Happy Friday and welcome back to The Microdose, an independent journalism newsletter brought to you by the U.C. Berkeley Center for the Science of Psychedelics.

Scientists test if ketamine’s antidepressant effects occur under anesthesia

Stanford anesthesiologist Boris Heifets and colleagues recently published a JAMA Psychiatry report testing the neurological effects of ketamine in different states of consciousness. This paper follows previous research from Heifets’s group that found that patients experienced relief from depressive symptoms after receiving either ketamine or placebo under anesthesia. “I looked back at what some of these participants wrote about their experience and it was clear that something really happened for them, even if they were given a placebo,” Heifets told The Microdose at the time.

In this most recent paper, the study authors similarly examined the effects of ketamine, known for its dissociative, analgesic, and antidepressant effects, while patients were under general anesthesia. The goal was to see what brain “signatures” of ketamine’s effects were present in the absence of conscious awareness. For example, the authors posit, in electroencephalogram (EEG) readings “ketamine’s antidepressant mechanisms have been attributed to high-frequency oscillations, while its dissociative properties have been linked to low-frequency oscillations.”

The authors conducted a secondary analysis on three studies that included dozens of participants who received a 40 minute infusion of ketamine, with or without general anesthesia. Participants’ EEG data showed that ketamine paired with anesthesia modulated the low-frequency theta-band signatures of ketamine that have been linked to dissociation, but not the high-frequency beta- and gamma-band signatures that have been linked to antidepressant effects.

The authors conclude that key aspects of ketamine’s biological actions are preserved while patients are under anesthesia, and that perhaps, distinct mechanisms of action of ketamine could be targeted for therapeutic development. The results could inform research to develop antidepressant therapies without inducing dissociation, they reason.

France is the first to approve IV ketamine for severe suicidal crisis

In March, French regulators became the first to approve intravenous racemic ketamine for treating adults in severe suicidal crisis. The racemic form of ketamine contains an equal proportion of two molecular structures, known as R- and S-ketamine, which are mirror images of each other. While a nasal spray with just S-ketamine (esketamine) has been approved elsewhere for treatment of major depressive disorder, studies have shown that racemic ketamine infusions can reduce suicidal ideation in just hours.

France’s “compassionate prescription framework” requires that ketamine be administered in hospitals, with a psychiatrist’s prescription. The country’s authorization “recognises not only ketamine’s clinical potential, but also the absence of any officially approved, evidence-based, rapid-acting pharmacological alternative when suicide risk is imminent,” French researchers wrote in The Lancet on April 11.

The FDA has previously issued warnings on compounded racemic ketamine’s risk of abuse and misuse, explaining that the drug has not been approved by the FDA for the treatment of any psychiatric disorders. In an opinion piece for The Clinical Trial Vanguard, chief editor Moe Alsumidaie argues that FDA regulators may want to question their hesitancy. French regulators “made a regulatory risk-benefit call that the FDA has not made,” he writes. “One authorization does not constitute a global evidence consensus — but it does constitute a precedent, and precedents in regulatory science travel.”

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Johns Hopkins psychedelics researchers report trip sitters are key to psychedelic experiences for patients in clinical trials. But what about for “healthy” volunteers?

It’s unclear just how much facilitators, the people who support trial participants before, during, and after a psychedelic experience, tangibly impact participants’ outcomes. The study authors set out to investigate this question by analyzing what they claim is the largest dataset of its kind, drawing from nine psilocybin studies including nearly 300 participants and 60 facilitators. They published their findings in the May 2026 issue of Psychiatry Research.

The authors compared participants’ reported psychedelic experiences and whether facilitators influenced that experience between two groups – those in clinical trial populations, with a condition like major depressive disorder or anorexia that researchers are hoping to treat, and “healthy” volunteers from other pharmacological studies. The researchers found that facilitators accounted for greater variance (over 13% of total variance) in participants’ “acute subjective effects ”(measured by the Mystical Experience Questionnaire) for clinical populations, compared to less than one percent variance accounted for in healthy volunteers. There is evidence from multiple studies suggesting that mystical-type experiences under psychedelics predict therapeutic benefits.

“For healthy volunteers, the experience was shaped almost entirely by the drug itself and individual differences, not who facilitated the session,” lead author Sean Goldy wrote on Bluesky. “Facilitators seem to have the biggest impact on psychedelic experiences when therapeutic stakes are highest.” The results should inform how clinical trials and therapies are implemented moving forward, the authors conclude.

Various state bills move to expand psychedelic research and access to the drugs

In Oklahoma, the Inter-Tribal Council of the Five Civilized Tribes unanimously passed a resolution in support of developing ibogaine as a treatment of addiction and trauma disorders, the Chickasaw Nation announced April 13. On the same day, the Oklahoma Senate Health and Human Services committee advanced HB 3834 to the Appropriations committee. The Oklahoma bill supports ibogaine clinical trials in partnership with a private drug developer, one of 13 states with similar proposals across the country.

Many states have also been considering “trigger law” bills that would change the legal status of certain psychedelics on the state level, if and when they are approved by federal regulators. Some specifically pave the way for UK-based pharmaceutical company Compass Pathways to roll out their proprietary formulation of psilocybin — “crystalline polymorph psilocybin,” also known as COMP360.

Earlier this month, Virginia’s governor signed companion bills to legalize psilocybin following FDA approval. If federal regulators decide to re-schedule a certain form of psilocybin in a healthcare setting, the legislation directs the state’s Board of Pharmacy to reschedule the same drug accordingly. COMP360 was not named specifically in this legislation. Elsewhere, Colorado’s rescheduling trigger bill, SB26-031, which would change state law if any Schedule I drug is federally approved for prescription use, was sent to the Governor on April 8 for him to sign or veto.

Lawmakers in Missouri are moving forward with HB 1717, directing the state to study psilocybin for conditions like major depression, PTSD and substance use disorder. Under the legislation, veterans and first responders could possess psilocybin for use with a facilitator, as long as they are enrolled in a therapeutic study. An amendment also directs the state Department of Health and Senior Services to award grants for ibogaine trials, and creates a “Ibogaine Intellectual Property Fund” for intellectual property revenue that may arise from drug development trials.

Connecticut Senators recently voted to expand access to the state’s psychedelics pilot program. SB 191 opens eligibility to residents 18 and over who meet clinical eligibility criteria for the state’s psychedelic-assisted therapy program, which includes MDMA and psilocybin studies. Currently, the pilot program is limited to veterans, retired first responders, and health care workers. Now, the bill is advancing to the House.

• According to CBS, the White House is currently drafting an executive order to further U.S. research into ibogaine. Two anonymous sources told CBS that President Trump could sign the executive order this week.

• On April 14, Compass Pathways announced plans to award up to three grants of $250,000 to U.S. organizations who apply to train healthcare providers on COMP360 psilocybin treatment and related protocols, if and when it gets regulatory approval.

• Psychedelic Alpha published a patent update covering Q1 of 2026. There were dozens of patent applications, including new entries from well-known organizations such as Reunion Neuroscience, Usona Institute, AtaiBeckley and Delix Therapeutics. Still, the larger story appears to be a deceleration in patents related to psychedelics. “Filing activity across the board has declined since 2023,“ the authors write.

• The Philadelphia Inquirer lab tested products marketed as psychedelic drugs in an investigation into Philadelphia’s unregulated market. These products took all sorts of forms including, candy ice cream cones and tablets and contained a wide range of ingredients such as synthetic analogs of psilocybin, a compound related to GHB (a notorious “date rape” drug), and in some cases, only THC.

• Colorado’s first licensed and operating psilocybin center is suing two former employees, accusing them of stealing trade secrets as they opened their own psilocybin healing center, Westword reports.

• The BBC published excerpts from a 1986 interview with Dr. Albert Hofmann recalling his historic first bike ride while tripping on LSD, commemorated by “Bicycle Day” events this weekend.

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Scientists engineered plants to produce five psychedelics at once

Scientists in Israel genetically engineered tobacco plants to simultaneously make five psychedelic compounds. Researchers added genes to the Nicotiana benthamiana plant that enabled it to produce psilocin and psilocybin, naturally found in mushrooms; DMT, known for its psychoactive effects in ayahuasca; and bufotenin and 5-methoxy-DMT, naturally secreted from the Sonoran Desert toad.

The authors published their findings on April 1 in Science Advances. Their goal is to allow for scalable production of psychedelics for therapeutics, without straining natural sources. “Harvesting these organisms for their psychoactive compounds raises ecological and ethical concerns, being increasingly threatened by habitat loss and overexploitation,” the scientists write.

Because the five psychedelic compounds contain similar chemical structures, scientists were able to genetically engineer plants to create all their biosynthetic pathways. After elucidating the complete biochemical pathway for DMT synthesis in plants, the authors went on to overexpress select enzymes in N. benthamiana, which prompted the production of all five psychedelic compounds within a week.

Producing the five drugs at once is not necessarily pharmacologically useful, Miami University bioengineer Andrew Jones (who wasn’t involved with the research) told Science. The psychedelics were produced at low concentrations when synthesized together, compared to when the synthetic pathways were expressed individually. Still, the paper’s authors said their genetically engineered plants demonstrate the feasibility of biosynthesizing psychedelic compounds in a more sustainable way.

‘Mega-analysis’ shows five psychedelics share a neural “signature”

In the largest analysis of its kind, an international cohort of scientists recently found that five psychedelics all produce strikingly similar changes in brain network connections. The authors applied a uniform analysis to brain scans from over 500 people on psychedelics from 11 datasets – bringing together evidence from 267 participants across five countries. They published their results April 6 in Nature Medicine.

The brain mechanisms behind psychedelics’ effects remain elusive. By analyzing multi-center functional magnetic resonance imaging, or fMRI, data, the researchers found psilocybin, LSD, mescaline, DMT, and ayahuasca all impact how brain regions involved in cognitive and sensory processing interact. Specifically, the scientists found increased functional connectivity between high-level cortical networks and networks for visual, tactile and motor processing.

“Usually, the brain’s perception of the external world is very distinct from our memory and abstract thinking,” lead author Manesh Girn told National Geographic. “This is suggesting the psychedelics might close that gap between how we think and how we perceive—between the internal and external.” In addition, the mega-analysis contradicts a popular theory that psychedelics ‘disintegrate’ brain networks, instead finding that the crosstalk between brain regions was boosted, Nature reports.

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Texas moves forward with ibogaine trials alone, after an unsuccessful search for a drug company partner

Texas plans to launch its ibogaine research program alone after its search for a drug company partner came up empty. The program was initiated by Senate Bill 2308 in 2025, kicking off a $50 million pledge of state dollars for ibogaine clinical trials. The legislation said state leaders must partner with a private drug developer that will collaborate to match state funds and help the trials advance towards Food and Drug Administration approval.

But on March 31, Lieutenant Governor Dan Patrick and House Speaker Dustin Burrows announced new plans after the state Health and Human Services Commission received no qualified drug company applications in its search. “Texas will proceed with our own research program,” Patrick and Burrows write in a joint statement. “We intend to fully fund this program, and will work in partnership with our great medical research teams in Texas to conduct the research.” Advocates said this move will position UTHealth Houston as the state’s “drug developer” and in total commit $100 million in Texas funds for the effort.

The state’s unsuccessful search for a drug company partner isn’t surprising, drug policy fellow Katharine Neill Harris of Rice University told multiple Texas news outlets. It suggests competitive companies were not enticed by the program outlined by Texas officials. “Without the private partner, I don’t know that they actually have the appetite to spend what needs to be spent on this,” Harris told the Dallas Observer. “I think $100 million is a kind of low-ball for what it would take to get to the FDA approval process.” The typical cost of developing new medications is nearly $1 billion, and sometimes more.

Following Texas, many other states are now passing similar legislation to initiate their own ibogaine research trials. For example, Mississippi’s HB314 requires its research consortium to partner with the same drug developer as the leading consortium in another state, Psychedelic Alpha reports. The non-profit advocacy group Americans for Ibogaine has championed these efforts. The group’s CEO W. Bryan Hubbard said Texas doubling its independent funds for this project is a “fabulous evolution of circumstances,” and added that other states may still decide to partner with private drug companies.

“Because of the nature of the multi-state framework that is being built, if the University of Texas at Houston falters in their execution of this project, then there are other states that are ready and willing to lead this effort nationally,” CEO Bryan Hubbard told The Microdose Wednesday.

UC San Diego study identifies factors associated with psychiatric hospitalization following psychedelics use

As recreational use of psychedelics continues to rise, UC San Diego researchers recently analysed emergency department visits associated with taking the drugs. The scientists looked at 232 cases associated with recreational psychedelic use at UC San Diego Medical Center between 2010 and 2023, and found about 11 percent of those patients required psychiatric hospitalization.

“Concurrent cannabis use and pre-existing psychotic or bipolar disorders are associated with increased odds of psychiatric hospitalization,” the authors write. Psychedelic clinical trials often exclude people who could have psychotic or bipolar disorders. The UC San Diego authors published their results on April 1 in the Community Mental Health Journal. They found most of the psychedelic emergency visits were made by patients who were young, white and male after they took LSD, MDMA, or psilocybin. Common symptoms were agitation, anxiety and nausea and vomiting.

U.S. Senators want to create a federal office to prepare for possible approval of psychedelic treatments for veterans

A bipartisan group of federal lawmakers recently introduced Senate Bill 4220 to establish an “Office of Novel Therapeutics” inside the Department of Veterans Affairs (VA). The goal is to have a center to coordinate research and care standards ahead of potential FDA approval of psychedelic treatments. The “Veterans Health Administration Novel Therapeutics Preparedness Act”, introduced in late March, directs the new office to make “implementation-readiness plans” and prepare the VA to approach such treatments safely.

“FDA approval is coming. This bill ensures the VA prepares now so it can deliver these treatments as soon as they’re available. Not years later,” Marine Corps veteran Juliana Mercer, executive director of the advocacy group Healing Breakthrough, told The Microdose Wednesday. “What the VA builds now, in clinical models, training, and reimbursement pathways, can shape how care is adopted across the broader healthcare system, including insurers and pharmacy benefit managers.”

The bill would also create a Veteran Advisory Committee on Novel Therapeutics to guide the office on patient safety, informed consent, and barriers to treatment access. The act would further help designate “Centers of Excellence” to lead the VA’s approach to new therapies and share their best practices with other VA centers. At the same time, S4031, the Innovative Therapies Centers of Excellence Act, is moving through the Senate. The act would establish and fund at least five VA centers focused on psychedelic therapies.

• On March 27, Japan’s Otsuka pharmaceutical company announced its American subsidiary will acquire Transcend Therapeutics, Inc. for $700 million dollars. Psychedelic Alpha reports Transcend’s methylone TSND-201 drug (an MDMA analog) will soon be tested for PTSD in a Phase 3 clinical trial.

• After receiving an unexpected marketing email recruiting influencers to publicize the promise of psychedelics on behalf of certain drug companies, STAT investigated such social media campaigns. They found the resulting exaggerated promos could undermine psychedelic biotechs’ efforts to “gain a foothold in the medical mainstream and with established pharma companies that may be interested in acquiring them.”

• Denver’s Rocky Mountain Poison and Drug Safety was recently promised an over $3 million federal grant to track psychedelics use for their years-long National Survey Investigating Hallucinogenic Trends, The Colorado Sun reports. (Read our September 5 questions with RMPDS’s Kari Rockhill for more on the center’s research.)

• Researchers are testing if psychedelic coaches, and the structured preparation and integration they can provide, improves the patient ketamine treatment experience, STAT reports in a Q&A with psychiatrist Franklin King of Massachusetts General Hospital.

• On April 8, Jasveen Sangha was sentenced to 15 years in prison after pleading guilty to selling ‘Friends’ actor Matthew Perry the ketamine that led to his death in 2023, AP reports.

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Two psilocybin bills progress in Massachusetts; Washington’s King County passes deprioritization proposal

The Massachusetts House Committee on Mental Health, Substance Use, and Recovery advanced two psilocybin bills last week. H.2203 would establish a pilot program run by the Department of Public Health to allow people with PTSD and other conditions to access psilocybin services, while H.4200 would establish a pilot program allowing licensed mental health treatment facilities to administer psilocybin.

In a press release from Mass Healing, an advocacy group whose leaders have been pushing for psychedelics reform in the state for years, the organization emphasized “the need for passage of a bill exploring therapies beyond psilocybin alone, including ibogaine.” In a LinkedIn post, Mass Healing co-founder thanked psychedelic advocacy organizations VETS and Americans For Ibogaine for their support, and pointed to testimony last fall from other groups, like MAPS, Clusterbusters, and Law Enforcement Action Partnership, as being influential in the bill’s advancement.

Washington State’s King County Council voted 6-2 to pass a motion stating the council’s support for continued entheogen-related research, and requesting that the investigation, arrest, and prosecution of “entheogen related activities” be among the county sheriff’s lowest priorities. Seattle, King County’s largest city, has already passed a similar motion, as well as other Washington cities like Tacoma, Olympia, and Port Townsend. King County Councilmember Reagan Dunn was one of the two councilmembers who voted against the motion, writing in a press release that “the State of Oregon experimented with full drug decriminalization in 2021. It failed so spectacularly and was so unpopular the state had to reverse course and re-criminalize in 2024.” Dunn’s statement incorrectly describes Oregon’s policies and inaccurately conflates them with the motion proposed in King County. Oregon voters passed a measure (110) in 2021 that lowered penalties for many drug-related offenses and provided an opportunity to waive some charges if those charged sought help from a drug hotline, but this did not constitute a “full drug decriminalization.” Meanwhile, King County’s policy calls for a deprioritization of county sheriff resources.

Unlike King County’s policy, Oregon’s Measure 110 included not just entheogens — a term which typically encompasses psychedelic substances such as psilocybin and DMT — but a wide variety of non-psychedelic drugs, including heroin and fentanyl. Indeed, in 2024, the Oregon legislature passed legislation reversing Measure 110 (for more on this, read our 5 Questions interview with attorney Jon Dennis); the bill’s supporters pointed to a rise in fentanyl overdose deaths in the state, despite evidence that decriminalization efforts and fentanyl deaths are not correlated.

Dunn’s statement reflects a common stumbling block in conversations around drug decriminalization: ambiguities regarding the definition of “decriminalization.” So-called decrim can mean changing the legal status of drug use, possession, transportation, or even sale so that they have no or decreased legal consequences (as in Oregon’s Measure 110), but it can also refer to a governing body directing local law enforcement to deprioritize the enforcement of existing drug laws (as King County’s proposal does).

New Mexico psilocybin program proposes new rules

New Mexico’s medical psilocybin program recently released a draft of proposed standards for psilocybin producers and testing labs. Some highlights:

• Dual ownership is not permitted; people who apply for a permit for one business may not have an ownership interest in another psilocybin business applying for a permit.

• Synthetic psilocybin is prohibited, as are pesticides

• Product packaging “shall not feature a design that is attractive to minors,” and must list total psilocybin and psilocin amounts

• Testing for adulterants like bacteria and heavy metals, as well as pesticides

• Businesses must have permits to transport psilocybin, and while doing so, they have to have the psilocybin in a locked container in a car with an alarm system

These are the first proposed rules for New Mexico’s Medical Psilocybin Program, which is set to launch later this year. Program staff will hold a hearing to discuss the proposed rules on April 24, 2026 in Santa Fe.

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AbbVie-acquired psychedelics company raises $60 million

New York-based psychedelics company Gilgamesh announced Tuesday that it had raised $60 million in its Series A financing round. This comes on the heels of news that its lead product, bretisilocin, was added to the European Medicines Agency’s list of priority medicines. Bretisilocin is chemically similar to DMT, but engineered to provide a roughly two-hour trip, rather than the approximately 15 minute duration of a typical DMT trip. The EMA’s designation means the drug will have an expedited drug application process.

The $60 million raised was the first formal round of financing after pharmaceutical company AbbVie acquired Gilgamesh’s bretisilocin program for up to $1.2 billion around six months ago. Gilgamesh is also developing what it bills as a “cardio-safe” ibogaine analog; a Phase 1 trial investigating the drug, GM-3009, is expected to begin this year.

Tracking psychoactive use via European wastewater

Wastewater analysis has been around for decades, but it became better known to the public after the rise of COVID-19, as researchers used wastewater to track the spread of the virus. A group analyzing sewage in 19 cities across Europe first formed in 2010, and since then, they have been tracking illicit drug use — specifically, cocaine, cannabis, methamphetamine, amphetamine, MDMA, and ketamine — through studying European wastewater. Last week, the European Union Drugs Agency released data that the group collected in 2025 across 115 European cities.

Overall, the researchers report that, unsurprisingly, metabolites of illicit drugs were found in all of the cities. From 2024 to 2025, the amount of MDMA in wastewater decreased by about 16%, but the overall amounts of ketamine increased by 41%. Belgium and the Netherlands seem to be hotspots for both, and many cities in those countries seem to have higher loads of MDMA or ketamine use over the weekend, as opposed to on weekdays.

The researchers note that the methods associated with wastewater analysis as a form of drug monitoring are still being improved. “Translating the total consumed amounts into the

corresponding number of average doses is complicated, as drugs can be taken by different routes and in amounts that vary widely, and purity levels fluctuate,” they write. Still, they say, the studies they’ve done so far present a “promising” method of monitoring drug use, a notoriously hard-to-study area.

Selection bias in psychedelic studies

Conducting psychedelics clinical trials is no small feat — only select institutions have the funds and resources to apply for the proper licenses to store and administer controlled substances and to obtain the required regulatory approvals of the research. It’s much easier to conduct studies of self reports of psychedelics users about their previous experiences, so many modern studies rely on survey data instead. But who chooses to participate in such surveys might represent a specific subset of people who are more enthusiastic about psychedelics than the average person.

A new study recently published in Journal of Psychoactive Drugs dug into this question by recruiting over 1100 participants to complete a survey about psychedelics. About half of the participants were what the researchers considered “psychedelic enthusiasts” — they were recruited via social media accounts of a psychedelic science nonprofit, while the other half represented what the researchers considered the “general population”; they had psychedelic experience but were recruited via an online survey platform.

Participants were asked questions like how their most meaningful psychedelic experiences affect their relationships and what their motivations are for using psychedelics, as well as a standard personality trait questionnaire. Overall, the researchers found that the psychedelic enthusiasts were much more likely to say that their psychedelic experiences influenced their quality of life in the long-term, even when controlling for other variables like personality traits. They conclude that recruiting participants through psychedelic groups can bias samples, as it likely favors people who have had good psychedelic experiences in the past. “Individuals who have had unremarkable or adverse psychedelic experiences are unlikely to be recruited through such channels,” the authors write, so studies that seek to represent the general public should take steps to recruit outside of these channels.

• Australia became the first country to allow physicians to legally prescribe psilocybin and MDMA to patients, but the high cost is preventing many from seeking treatment, The New York Times reports.

• What are the legal ramifications of operating a foreign psychedelic retreat center? Attorney Jason Adelstone details a range of liability considerations in Harris Sliwoski’s Psychedelics Law Blog.

• The Wall Street Journal reports on the rise of mail-order ketamine and on the death of Tricia Anne Dewey, whose family is suing a telehealth company called Better U after it provided a ketamine prescription to Dewey, which ultimately played a role in her death.

• Tech founder turned longevity influencer Bryan Johnson livestreamed his 5-MeO-DMT trip on X, during which UCSF psychedelics researcher Robin Carhart-Harris joined him on the livestream. Johnson has been experimenting with psychedelics in an effort to boost longevity. In November, he also took large doses of psilocybin, livetweeting and then streaming his trips.

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New analysis: Psychedelics may be no better than SSRIs in treating depression

For the last few decades, medications like Zoloft, Lexapro, Prozac, and Effexor — known as SSRIs and SNRIs — have been the dominant medications prescribed for depression. Psychedelics are often touted as a more effective or “natural” alternative to these drugs, but according to a new analysis published in JAMA Psychiatry this week, psychedelics may not be more effective than SSRIs or SNRIs in treating depression.

In order to receive approval from the U.S. Food and Drug Administration, drug developers must show that their drug is not only safe but also more effective than a placebo. The SSRIs and SNRIs on the market have already undergone this process, and as companies seek to bring psychedelics to market, many have attempted to conduct double blind trials with psychedelic-assisted therapy (PAT) — trials where neither participant nor clinician know whether the participant has received a psychedelic or a placebo. But because psychedelics produce marked subjective effects like perceptual alterations and mystical experiences, it’s quite difficult to achieve functional blinding — the paper’s authors say that in PAT trials, participants’ guesses about which condition they’re in are accurate up to 95% of the time.

Only one study so far has compared the efficacy of PAT to the existing dominant depression treatment, SSRIs, and in that study, there were no significant differences in treatment outcomes between groups. The authors of the new meta-analysis set out to probe that further by comparing studies of psychedelic-assisted therapy with open-label SSRI and SNRI studies — studies where participants know whether they are receiving an antidepressant or a placebo. Their logic: since all PAT studies are, essentially, open-label (participants can generally tell whether they are receiving a psychedelic or placebo), it’s only fair to compare PAT to open-label SSRI studies.

In a meta-analysis, the three researchers included data from 24 previous studies using either psychedelic-assisted therapy or open-label SSRI/SNRIs, and compared changes in participants’ scores on the Hamilton Depression Rating Scale, a widely-used depression assessment. They found virtually no difference in Hamilton scores between participants who received PAT vs. participants who were given traditional antidepressants.

Moreover, they found that participants in the placebo arm of PAT trials show significantly worse depression symptoms than people in the placebo arms of SSRI or SNRI clinical trials. “We speculate that this suppressed placebo response in PAT trials is attributable to the ‘know-cebo’ effect,” the authors write, referring to the disappointment patients can experience when they realize they got the placebo instead of the psychedelic. (For more about the know-cebo effect, read our 5 Questions interview with study co-author and UC San Francisco researcher Balázs Szigeti.)

Overall, the analysis suggests that participants’ expectations play a substantial role in their clinical outcomes, and, the authors write, it “presents a sobering viewpoint on [PAT]’s potential.”

Kentucky ibogaine bill and New Mexico psilocybin equity fund

Kentucky legislators are considering Senate Bill 77, which would establish a public-private fund to conduct ibogaine research. The bill is one of at least a half-dozen introduced across the U.S. that promises states a portion of intellectual property rights if ibogaine is approved by the Food and Drug Administration as a drug. The initial version of the bill included appropriating $42 million from the state’s opioid abatement trust into the established fund, but that part of the proposal was removed in committee amendments.

Last week, the bill passed the Senate 35-2 and is now with the House. Kentucky’s legislative session ends in the next couple weeks, which means the bill must move swiftly through the House to be viable. The seed for Americans for Ibogaine, the advocacy group drafting the ibogaine bills introduced nationwide, was first planted in Kentucky; co-founder W. Bryan Hubbard, then chair of the state’s Opioid Abatement Advisory Commission, introduced a proposal to use $42 million of Kentucky’s opioid settlement money for ibogaine research. (The proposal lost steam once Hubbard was replaced by the incoming attorney general’s new appointee.)

Last week, New Mexico Governor Michelle Lujan Grisham (D) signed a bill establishing the state’s annual budget. That included an extension of the $1 million already allocated to run the state’s medical psilocybin program, which announced in late 2025 that it would be launching by the end of 2026, a full year earlier than originally planned. An additional $300,000 will cover psilocybin research for end-of-life and palliative care, as well as $630,000 for a newly-established Medical Psilocybin Treatment Equity Fund. “With the investment in this fund, our state leadership is sending a clear message: access to treatment in New Mexico will not be based on ability to pay,” Healing Advocacy Fund’s New Mexico director of strategic support Denali Wilson said in a statement.

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Bretisilocin becomes first psychedelic to receive EU designation

In the U.S., promising drugs under development can receive “breakthrough therapy” designation by the Food and Drug Administration which expedites a drug’s review. The EU’s European Medicines Agency (EMA) offers a similar pipeline, called the Priority Medicines (PRIME) scheme, which aims to expedite the drug application process. Recently, the EMA added the psychedelic compound bretisilocin to its list of PRIME medications. Bretisilocin is chemically similar to DMT, but was engineered by researchers at psychedelic company Gilgamesh Pharmaceuticals to provide a roughly two-hour trip, rather than the 15 or so minutes a DMT trip lasts. About six months ago, pharmaceutical company AbbVie acquired Gilgamesh’s bretisilocin program for up to $1.2 billion.

Tadeusz Hawrot, founder of the advocacy group Psychedelic Access and Research European Alliance (PAREA), wrote on LinkedIn that this move “could be an important turning point.” PRIME designation is far from authorization, and bretisilocin is just one drug, he said, “but it could signal a shift towards Europe becoming more relevant in psychedelic drug development and, eventually, access.”

Psychedelic Medicine Association creating accreditation program

The Psychedelic Medicine Association, a public benefit corporation dedicated to psychedelic education, announced it has founded a non-profit arm that will create an accreditation program for psychedelic facilitators. The PMA was founded in 2020 to educate healthcare professionals about psychedelics; for more about the organization, read our 5 Questions interview with co-founder Lynn-Marie Morski.

In a video posted to LinkedIn, Morski compared the creation of a psychedelic facilitator accreditation to the accreditation board that certifies physicians. She pointed to a lack of standardization across psychedelics training programs, giving the example that while some programs require two years of training, UCLA offers a psychedelic-assisted therapy training program that consists of a 4-hour seminar.

Morski also raised the possibility that having a third-party accreditation body could be a boon to psychedelics’ acceptance in the long-term; she mentioned the report that the Institute for Clinical and Economic Review (ICER) released shortly before the FDA declined to accept Lykos’s new drug application for MDMA. That report recommended “rigorous certification and oversight of providers,” suggesting that a third party group like the American Psychiatric Association or American Psychological Association could take this on as a way “to reduce potential conflicts of interest in maintaining the highest standards.”

The PMA’s efforts are still in their infancy; Morski said the group was in the process of designing a core curriculum in hopes that it could establish international standards, and that it was piloting assessments and planning to gather feedback from graduates of training programs. In the half-decade since above-ground psilocybin facilitator training programs first began taking applicants to work in Oregon state’s psilocybin industry, there’s been a boom and bust — some training programs have shuttered amidst scandal, and some graduates report difficulties in finding work. The announcement signals the growing professionalization and regulation of the psilocybin industry.

Oregon palliative psilocybin lawsuit inching forward

On Tuesday, an Oregon judge ruled that Cusker v. Oregon Health Authority, a lawsuit filed in U.S. District Court back in 2024 by four trained Oregon psilocybin facilitators against the state agency that oversees psilocybin services in the state, may proceed. In the suit, psilocybin facilitators allege that the Oregon Psilocybin Services’ requirement that all psilocybin sessions take place in a service center violates the Americans with Disabilities Act (ADA). Facilitators say some of their clients with disabilities or terminal illnesses are unable to leave their homes and travel to service centers, and that the state has not made reasonable accommodations for those clients, as required by federal law. (I wrote about the case for OPB in late 2024.)

Since the suit was filed, the State of Oregon’s attorneys, representing the Oregon Health Authority, have fought to get the case dismissed. First, they argued that federal court was the wrong venue for the lawsuit, but in a February 2025 hearing, Judge Mustafa Kasubhai denied that move. In the case’s most recent volley, Oregon’s attorneys say that the claims of the plaintiffs — the psilocybin facilitators — are “too speculative,” because they allege only future harms to clients who might be denied psilocybin services, and none have disabilities themselves. Judge Kasubhai, again, denied the defense.

“We are pleased that the Court has denied OHA’s attempts to avoid review of the merits. We will now move forward, seeking to ensure access for disabled and dying Oregonians,” Kathryn Tucker, an attorney representing the plaintiffs, said in a statement shared with The Microdose. Next, she said, the plaintiffs will file a motion asking the court to require OHA to allow accommodations for homebound Oregonians seeking psilocybin services.

• Elon Musk is suing OpenAI and its cofounder Sam Altman, alleging the company “defrauded” him in how it represented its intentions to remain a non-profit. According to Bloomberg, OpenAI’s defense had intended to “undermine Musk’s credibility on the witness stand by asking him about his alleged use of ketamine during key negotiations with the company” — apparently, “significant communications” between Musk and OpenAI took place at Burning Man. But a judge ruled last Friday that she would not allow this line of questioning of Musk “unless OpenAI can provide more concrete evidence about the mind-altering effects of ketamine, an anesthetic drug that can have hallucinogenic properties.”

• Writer Shanetta McDonald writes in Essence that at first, she thought traveling to Costa Rica for an ayahuasca retreat might be “the most non-Black thing I’ve ever done” — but she was pleasantly surprised to find several other “melanated women” at her retreat, and “left Costa Rica with an expanded view of who has the right to heal.”

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Psilocybin shows promise over nicotine patches to help tobacco smokers quit

As researchers continue to explore psychedelics’ potential in addiction treatment, a recent pilot trial found psilocybin prevailed over a nicotine patch in a test to help tobacco smokers quit.

Results from the randomized clinical trial were published Tuesday in JAMA Network Open. Researchers recruited 82 tobacco smokers at Johns Hopkins Bayview Medical Center and randomly assigned them to receive either a relatively high (30 mg) dose of psilocybin or weeks of using a nicotine patch. Both treatment conditions were paired with 13 weeks of cognitive behavioral therapy designed to help smokers quit.

Those who received a single dose of psilocybin were over six times more likely to have remained abstinent after six months than participants who used nicotine patches. About 40% of the psilocybin group successfully stopped smoking, whereas only 10%, or 4 people, in the patch group quit. Cigarette smoking is a leading preventable cause of death in the U.S., and 2022 data shows fewer than 10% of adult smokers successfully quit in the past year.

Tobacco dependence researcher Megan Piper, who wasn’t involved in the trial, told NPR the findings suggest a promising new treatment option, but will need to be replicated in a larger, more diverse study. The researchers who led the trial are currently testing psilocybin for tobacco use disorder in a Phase 2 clinical trial with a placebo condition. Tobacco use disorder is a chronic and relapsing addiction to tobacco products characterized by an inability to quit.

Scientists discover a new species of psychedelic mushroom in Africa

Scientists discovered a new species of psychedelic mushroom from sub-Saharan Africa. The study, published Wednesday in Proceedings of the Royal Society B, describes the new species, Psilocybe ochraceocentrata, as a close relative of the well known Psilocybe cubensis. “This discovery sheds light on the wild origins of domesticated P. cubensis and provides new genetic resources for research on psychedelic mushrooms,” the researchers write. Using genetic analyses, the researchers suggest the two species likely diverged from a common ancestor approximately 1.5 million years ago. The discovery hints at the evolutionary origins of Psilocybe mushrooms, which has been debated.

The study authors suggest the two species, whose spores commonly spread on animal dung, diverged through “global ecological shifts” such as the migration of Homo erectus and grazing herbivores out of Africa and the trans-Atlantic dispersal of grass seeds and dung beetles from Africa to South America. These shifts, which occurred more than a million years ago, “opened novel niches for dung-specialist fungi.”

The researchers say the newly discovered species was likely being misidentified as P. cubensis for years. “Incorrect species designations like this could lead to widespread confusion over the species identity of commercially sold Psilocybe,” the authors write.

The new species is one of seven in the Psilocybe genus that are native to Africa, they add. Altogether, there are approximately 160 species of Psilocybe, mostly documented in the Americas. There are likely many undocumented species in Africa due to less mycological survey work across the continent, the authors said.

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Minnesota lawmakers advance psilocybin-assisted therapy bill. Plus, ibogaine research bill approved in Mississippi.

On Monday, Minnesota lawmakers in the House Health Finance and Policy Committee approved a bill that would state-legalize a psilocybin therapy program for adults 21 and older.

Under the bipartisan proposal, HF 2906, residents could receive psilocybin-assisted therapy “administered under strict supervision by a licensed facilitator.” The initial program would allow a maximum of 1,000 patients “with qualifying medical conditions” to receive the therapy in the first three years, with the guidance of no more than 50 registered facilitators. Qualifying conditions include posttraumatic stress disorder, depression, substance use disorders, anxiety, and chronic pain. The move follows a state task force recommendation to create a regulated clinical psilocybin program.

“It will help Minnesotans who are struggling with a wide variety of mental illnesses,” Representative Andy Smith (D) said Monday. “It builds on successful programs in other states like Oregon, Colorado and New Mexico.” The legislation sets aside money from the state’s general fund for management of the program. It also says registered facilitators can charge for their services.

The bill would also reschedule psilocybin and psilocin from Schedule I to IV on the state’s controlled substances list. Schedule I drugs are the most restricted and characterized as having high abuse potential and no accepted medical use. Also on Monday, the Minnesota State Senate introduced a separate bill aiming to eliminate criminal and civil penalties for psilocybin use and possession.

Meanwhile, on Tuesday Mississippi state senators voted to pass House Bill 314, which would create a system for ibogaine clinical trials. This appears to be the House version of SB 2561, which died in committee. According to lawmakers, the goal of the legislation is to provide the U.S. Food and Drug Administration with data on the safety and efficacy of ibogaine to treat conditions including opioid use disorder.The bill is returning to the state House with an amendment for a vote before it could advance to the governor’s desk.

It’s similar to other state-level ibogaine research bills across the nation, as it promises states intellectual property royalties if the drug is ultimately FDA approved. Under the bill, some state funding would be directed to the trials, perhaps opioid settlement funds. The amendment states that people leading the ibogaine trial must “plan to secure third-party payor approval for ibogaine treatment following approval by the FDA through: private insurers; Medicare; Medicaid; and the TRICARE program of the United States Department of Defense.”

Mississippi State Senator Josh Harkins (R) suggested Mississippi’s trial could have a “multiplier effect,” on ibogaine research already funded by laws passed in Texas and Arizona.

Psychedelics with exercise to treat major depressive disorder?

A commentary published March 7 in Discover Mental Health suggests psychedelics and exercise could be used together to treat major depressive disorder. Both approaches show promise alone, and could have “synergistic antidepressant effects,” psychedelics researchers Nicholas Fabiano, Robin Carhart-Harris and collaborators argue. “Exercise and psychedelics have numerous potential complementary mechanisms,” they write, warranting future research on their use together.

Both approaches boost glutamate, serotonin, neuroplasticity, and brain-derived neurotrophic factor. Exercise may even have the potential to sustain or enhance the effects of psychedelics, through psychological flexibility and default mode network connectivity, the authors add.

Athletes using psychedelics during sport isn’t a newfound idea. American baseball pitcher Dock Ellis famously threw a no-hitter game in 1970 while tripping on LSD. The professional surfer Darryl Virostko, nicknamed “Flea,” first surfed California’s giant Mavericks waves while high on LSD. (For more on athletics and psychedelics see our 5 Questions interview with sports psychologist Courtney Walton.)

• Writer and emergency medicine doctor Clayton Dalton digs into the world of non-psychedelic psychedelic medicine in The New Yorker. This story was reported with the support of the Ferriss-UC Berkeley Psychedelic Journalism Fellowship.

• Colorado transportation officials concerned about people driving while microdosing are urging residents to “plan your trip before you trip,” according to the Denver Post.

• The New York Times reports that memoirist Amy Griffin, whose best-selling book The Tell recounts sexual abuse by a teacher in Texas, is being sued by a former classmate. The woman alleges that the abuse Griffin describes in her book was based on experiences she’d shared from her own life. Griffin, who is also a philanthropist in the psychedelic space, wrote about retrieving these repressed memories of abuse through MDMA therapy. Griffin’s lawyer denies the classmate’s charges.

• A commentary published in Psychedelic Medicine discusses an increase in “naturalistic use” of psychedelics, citing data that shows reported psilocybin use in the past year rose 188% between 2019 and 2023 for U.S. adults 30 and above. The surge highlights a need for more robust epidemiological research to better understand risks and benefits, the authors argue.

• On March 5, a United States District Judge sentenced a New York man to over 6 years in prison for trafficking MDMA by mail. Homeland Security investigations reportedly seized over 10 kilograms of MDMA as part of the case.

  

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AtaiBeckley’s MDMA product could treat social anxiety

Last Thursday, AtaiBeckley announced preliminary results for a Phase 2a clinical trial using a formulation of MDMA to treat social anxiety. MDMA is typically a “racemic mixture,” meaning it contains an equal proportion of two molecular structures, known as R-MDMA and S-MDMA, which are mirror images of each other. AtaiBeckley’s drug candidate, which they call EMP-01, is a formulation of only R-MDMA. Previous research has suggested that while S-MDMA is associated with strong visual effects and higher blood pressure, R-MDMA more strongly activates serotonin 2A receptors.

In the company’s study, 69 UK adults who had been diagnosed with social anxiety disorder received a dose of either EMP-01 or a placebo capsule, then a second identical dose four weeks later. Notably, the participants did not receive psychotherapy. Two weeks after their second dose, participants’ social anxiety symptoms were assessed and compared to their baseline scores from before the study.

According to AtaiBeckley, participants who received EMP-01 showed a clinically meaningful improvement in their symptoms, as measured by a social anxiety scale. The study results have not yet been published in a peer-reviewed journal. When the paper undergoes peer review, reviewers will more substantively assess whether the company’s data support their claims.

In December, AtaiBeckley announced that the U.S. Patent and Trademark Office granted the company a patent for EMP-01. But they’re not the only company developing R-MDMA products; last year, San Francisco-based Arcadia received Investigational New Drug status from the Food and Drug Administration for its R-MDMA formulation, which it calls AM-1002, in the treatment of anxiety, and New York-based company MindMed also has an R-MDMA research program, investigating its use in people with autism spectrum disorder.

HHS Secretary Kennedy talks psychedelics on Rogan podcast

On Friday, Health and Human Services Secretary Robert F. Kennedy Jr. appeared on podcaster Joe Rogan’s show.

Both the podcaster and HHS secretary agreed psychedelics could be helpful in treating people with addiction or mental health issues, especially veterans and police officers. Both repeated common talking points about psychedelics advanced by testimony in state legislature from veterans groups: that the substances can “rewire the brain,” and that veterans should not have to give everything to their country only to be forced to go to Tijuana for psychedelic mental health treatment afterward. The two pointed to their personal connections to ibogaine; Rogan said he had many friends who had positive outcomes from trying ibogaine, and Kennedy said he, too, had a family member who tried it, and he pointed to his own decades-long recovery from heroin addiction. “It’s pretty hard to convince me that you can fix what’s wrong with you by taking something outside of you, but I have seen so much overwhelming anecdotal evidence, but also clinical studies that attest to the effectiveness under some circumstances with some people for these medicines,” Kennedy said.

While Rogan pressed Kennedy on specifics — what hurdles he faces in rolling out treatment, and what the result could look like — Kennedy spoke only in generalities, saying the government is developing guidelines for therapeutic treatments and follow-ups, and that he, personally, would like to see such treatment take place in a “very controlled setting.” “You need to move in baby steps,” he said. He also incorrectly suggested that the VA is conducting clinical trials with ibogaine.

“Everybody in my agency and over at Veterans Affairs is very anxious to get a rule out there that will allow access under therapeutic settings, particularly in the military,” Kennedy said. “We’re all working on it.” He said that he meets every day with NIH director Jay Bhattacharya, FDA chief Martin Makary, and Administrator for the Centers for Medicare & Medicaid Services Mehmet Oz — according to Kennedy, the health leaders are “like family,” even vacationing together, and are “doing whatever they can” to move psychedelics treatments forward.

These remarks come after some psychedelics advocates have voiced disappointment with the Trump administration not meeting initial promises that psychedelics might be fast-tracked. In July 2025, Kennedy said that psychedelics would be available within 12 months, but so far, there has been little tangible action taken by the administration. In fact, the Trump administration recently blocked the FDA’s bid to fast-track the approval of Compass’s synthetic psilocybin COMP360.

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West Virginia Senate and South Dakota legislature pass Compass trigger bills

On Friday, the West Virginia Senate voted 31-2 to pass Senate Bill 906, which proposes amending state law to permit the prescription, distribution, and marketing of “crystalline polymorph psilocybin” should the U.S Food and Drug Administration approve and reschedule the drug. The bill is the latest so-called “trigger law” that paves the way for UK-based pharmaceutical company Compass Pathways to roll out their proprietary formulation of psilocybin — “crystalline polymorph psilocybin,” also known as COMP360.

Over the last year, Compass has introduced similar bills in at least ten states, and the company’s associate director of government affairs spoke to the Vermont Senate Committee on Health and Welfare on this issue just two weeks ago. Many lawmakers and their constituents are seemingly unaware that these bills are written in such a way that would permit only Compass’s formulation of synthetic psilocybin — not psilocybin mushrooms, or even other psychedelic pharmaceutical companies’ psilocybin products — to be used in the state. One local news source asserted that if passed, “West Virginia would join the likes of Oregon and Colorado, which already have laws legalizing the supervised medical use of psilocybin.” That’s not correct — both Oregon and Colorado’s program exist independently of FDA approval (and Oregon Psilocybin Services is not a medical program), and explicitly use whole mushrooms, not any synthetic formulation (and certainly not Compass’s proprietary formulation).

Meanwhile, the West Virginia Senate is also considering an ibogaine bill: House Bill 4626, which proposes funding ibogaine research through a public-private partnership program, passed the WV House in late January and is currently with the Senate Finance committee.

The South Dakota legislature also just passed a similar trigger bill, House Bill 1099, which would move “crystalline polymorph psilocybin” from Schedule I to Schedule IV in the state’s controlled substances act if it is approved by the FDA. In the floor discussion, Senator Greg Blanc (R) opposed the bill, saying it would be a return to the Woodstock era and calling proposals to use the drugs to treat service members “experimenting on veterans.” Assistant minority leader Jamie Smith (D) spoke in favor, reiterating that the drug’s legal status in the state would only change if approved by the FDA, and asserting that a counselor and doctor would be present during the drug’s administration. (That might be the case, but those details would be determined by any Risk Evaluation and Mitigation Strategies — or REMS — issued by the FDA in the event of approval.) Ultimately, the Senate voted 21-12 to pass the bill, which now heads to Republican Governor Larry Rhoden’s desk for a signature.

Pilot study uses psilocybin for post-treatment Lyme disease

Psychedelics have been posited as a treatment for a variety of ailments, from mental health disorders such as depression and anxiety to addiction and chronic pain. A study recently published in the Nature journal Scientific Reports suggests it might also be used in the treatment of post-treatment Lyme disease (PTLD), a chronic condition that arises after people recover from bites from Lyme bacteria-carrying ticks. People with PTLD often report fatigue, mood changes, pain, and a general decrease in quality of life.

In the study, Johns Hopkins researchers treated 20 participants with PTLD with two psilocybin sessions and psychological support, which the researchers define as “nondirective” and focusing on goals and education rather than explicit psychotherapy. Over the following six months, participants reported significant improvement in their symptoms and quality of life.

“We consider the current findings to be sufficiently positive to encourage additional randomized controlled research with psilocybin in patients with PTLD,” the researchers write — and given that there are currently no accepted treatments for PTLD, psilocybin seems especially promising. The researchers also propose further investigation of psilocybin and other psychedelics as a treatment for other infection-associated chronic conditions such as myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS), post-acute sequelae of SARS-CoV-2 infection (PASC), and fibromyalgia, that may benefit from similar approaches.

Psychedelic-assisted therapy bill rejected then resurrected in Georgia

On Tuesday, the Georgia House voted 88-73 to reject House Bill 717, which proposed rules governing clinics offering psychedelic-assisted treatment — including ketamine clinics — in the state. Among those rules was the requirement that physicians practicing in any ketamine or psychedelic clinic meet competency requirements for psychedelic-assisted treatment and therapy, and that clinics must be majority owned by physicians. According to local news site Savannah Now, “critics saw HB 717 as an attempt by doctors to corner the [ketamine] market.” However, the bill’s sponsor, Georgia Representative Sharon Cooper (R), saw it as a proactive way to put regulations in place to dictate not only ketamine clinics, but other potential psychedelics clinics. “There are more psychedelic drugs coming that are under study now that are even more dangerous,” she told Capitol Beat News Service. “How about Ecstasy? Or magic mushrooms?” The next day, the House passed another measure — 159 to 8 — to reconsider the bill at a later date.

• “Telehealth companies are mailing a Schedule III narcotic to tens of thousands of depressed patients, hailing it as the democratization of mental health. They call it access. I call it abandonment,” writes Michael Alvear in a STAT News op-ed. Alvear runs a patient advocacy site called Ketamine Therapy for Depression, and raises the alarm about mail-order ketamine companies.

• In a commentary piece published in Nature, researchers Eduardo Schenberg, Franklin King IV, and Marion Haberkamp call on researchers to more carefully assess and report the effects of blinding in psychedelics clinical trials, as unblinding can affect participants’ expectations, which in turn can bias outcomes.

• Researchers believe they may have solved part of the mystery of kykeon, the brew supposedly consumed by Marcus Aurelius, Cicero, and other ancient Greek legends in a multi-day rite known as the Eleusinian Mysteries. For Science, journalist Rachel Nuwer reports on the new findings and what other religious history scholars make of them.

• Psychedelics came up in U.S. v. Hemani, a Supreme Court case that could change a federal statute that prohibits anyone who is “an unlawful user of or addicted to any controlled substance” from owning a gun. According to the New York Times, Justice Elena Kagan brought up ayahuasca as a hypothetical case: when people are under the influence of ayahuasca, “reality dissolves,” Kagan says, but the substance is not addictive and only temporarily alters consciousness.

• For WIRED, journalist Webb Wright reports on a new DMT retreat calling itself a “SETI for the mind,” which aims to establish communication between trippers and the non-human entities they encounter on their journeys.

• Vanity Fair’s “guide to microdosing” takes a tongue-in-cheek approach to identifying the macro and micro effects of various psychedelics, who is trying them, and where they live. (Psilocybin microdosers? “Overextended elder millennial moms.” Ibogaine microdosers? “Your weirdest friend’s weirdest friend.”)

• New York Times political reporter Robert Draper went to the ibogaine clinic Ambio Life Sciences in Tijuana, Mexico, and recounts his experience with the substance and the memories and questions his trip resurfaced.

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Editor’s Note: I'm thrilled to introduce Anna Marie Yanny, a neuroscience researcher turned science journalist and radio producer. She's joining The Microdose to help cover This Week in Psychedelics on Fridays. This is her first post.

The FDA is changing the drug approval process

The U.S. Food and Drug Administration is moving to require only one “pivotal trial” for drug approvals, instead of the historical two-study requirement. (A pivotal trial is almost always a Phase 3 trial.) The change could be welcome news for psychedelics companies planning to seek approval. But some scientists worry that the sweeping change will limit safety and efficacy data, especially for psychiatric studies.

The FDA announcement came via a Feb. 18 publication in the The New England Journal of Medicine authored by FDA Commissioner Marty Makary and Vinay Prasad, director of the Center for Biologics Evaluation and Research. It notes the FDA currently can, and often does, allow a drug to proceed to market following one “adequate and well-controlled study” paired with “confirmative evidence.”

The new two-trial standard was implemented “in a world where biologic understanding was more limited than it is today,” the FDA leaders reason. In 2026, they write, researchers have other ways – like statistical power, blinding, and robust control groups – “to feel assured that our products help people live longer or better than requiring manufacturers to test them yet again.” Some studies will still need two trials, but one will be the new default, FDA Commissioner Makary told STAT in December.

In their commentary, FDA leaders wrote that the one-trial standard ”will substantially reduce costs for sponsors and will speed drugs to market.” Psychedelic Alpha reports the change could potentially allow the non-profit Usona Institute’s psilocybin formulation to piggyback on a possible Compass Pathways approval for synthetic psilocybin, which may happen as early as next year. Usona Institute has completed a single Phase 3 trial, and COMPASS recently announced results from its second.

After the FDA announcement, several scientists voiced their concern about the change, suggesting it could hinder rigorous verification of a drug’s safety and efficacy.

“Besides setting a lower bar for FDA approval standards by setting a default of 1 instead of 2 clinical trials (what happened to reproducibility as gold standard science?!), they sell the policy as a gift for pharma (less to do to prove the drug actually works!)” Yale School of Medicine assistant professor Reshma Ramachandran posted on X.

Studies on treatments for cancer or rare diseases historically benefit from single-trial review, but it’s unclear what this move will mean for psychiatry and psychedelics. A JAMA study analyzed a cohort of drugs, many of them for cancer, that achieved FDA approval in 2020, and found over half were supported by just one pivotal trial.

According to The Wall Street Journal, the one-trial change and other frustrations led to the abrupt departure in December of Richard Pazdur, the FDA’s director of the Center for Drug Evaluation and Research.

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In a Senate hearing, Surgeon General nominee Casey Means was asked about psychedelics use.

President Trump’s U.S. Surgeon General nominee Casey Means testified at a Senate committee nomination hearing on Wednesday. She and her brother, Calley Means, have both publicly advocated for psychedelics access. He is a senior advisor in the U.S. Department of Health and Human Services.

In the hearing, Means was mostly asked about her views on vaccination but several questions were also raised about her experience and opinions on psychedelics, which she described in her 2024 book Good Energy. The book was written together with her brother.

In the book, Means advocates for psilocybin-assisted therapy. “If you feel called, I also encourage you to explore intentional, guided psilocybin therapy,” she writes. “Strong scientific evidence suggests that this psychedelic therapy can be one of the most meaningful experiences of life for some people, as they have been for me.”

In Wednesday’s hearing, Senator Susan Collins (R-ME) raised concerns about Means’s enthusiasm for psilocybin mushrooms and asked Means if she would endorse illicit drug use when speaking to the American public.

“What I would say as a private citizen is, in many cases, different than what I would say as a public health official,” Means responded. “And when it comes to psychedelic therapy for mental health issues, I think the science is still emerging … under no circumstances would I recommend that to the American people in this role.” She went on to say she believes that many psychedelic therapy studies are “exciting” and should continue.

Means’s somewhat tepid response may add to existing disappointment from some psychedelic advocates who had hoped that the Trump Administration would have moved more quickly on psychedelic access.

The committee will vote on Means’s nomination soon. If approved, her nomination moves to the full Senate for a vote. The Senate is expected to confirm her.

RAND survey shows that nearly a quarter of U.S. adults support legal use of psilocybin mushrooms

About one quarter of U.S. adults support legal use of psilocybin mushrooms, according to a national report published by the RAND research organization on Tuesday. Support for legal use of LSD or MDMA was closer to 10%. For context, approval for cannabis legalization was much higher, at around 65%.

The 2025 RAND Psychedelics Survey includes responses from 10,122 U.S. adults gathered between Sept. 9 and Oct. 1, 2025. Researchers said it’s the first survey of its kind to ask about policy preferences for individual psychedelic substances, instead of psychedelics as a general category.

The survey found support for legalizing psilocybin was similar to attitudes towards cannabis in the mid-1990s, before states began implementing medical marijuana laws. “Perspectives shift depending on the substance and the reason for use. Recognizing these nuances can help shape more informed research and policy discussions,” said lead author Ben Senator in a press release.

When asked where people should access psilocybin if legal, nearly half of survey respondents said under supervision at a medical facility. Meanwhile, 28% said a dispensary, and about 23% endorsed a “grow and give” system.

The most common reason people gave for endorsing legal use of psychedelics was to address mental or physical health conditions. Opinions on the drugs differed depending on respondents’ age and sex, as well. For example, about 29% of males supported legalizing psilocybin, compared to about 18% of females. And about 31% of 18 to 29 year olds supported it, compared to about 11% of those 60 and older.

Reunion Neuroscience gets FDA Breakthrough Therapy status

On Monday, biopharmaceutical company Reunion Neuroscience, Inc. announced the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for use of its proprietary drug “luvesilocin” (formerly RE104) in treatment of postpartum depression. Luvesilocin is a prodrug of the psilocin analog 4-OH-DiPT. (A prodrug is an inactive, or less active compound that is converted to the active drug by the body.) Reunion designed luvesilocin to deliver a shorter psychoactive experience (about 2-3 hours), compared to psilocybin trips that can be twice as long.

Since 2017, the FDA has issued at least eight other psychedelic treatment protocols Breakthrough Therapy Designation. The designation is designed to fast track the review process for drugs meant to treat serious conditions.

The company plans to launch a Phase 3 clinical trial in 2026 for postpartum depression treatment. Reunion expects the results from a single Phase 3 trial would amount to sufficient data collection FDA review.

• Michael Pollan’s tenth book “A World Appears: A Journey into Consciousness” is out this week (a journey that includes psychedelics). “Along the way,” DoubleBlind’s Shelby Hartman writes for The Los Angeles Times, “he realizes that the ethical significance of his investigation is much greater than he first imagined.”

• A Utah bill that would create a clinical study testing psychedelic-assisted therapy for veterans with PTSD passed in the House Feb. 18 and now moves to the Senate.

• In an op-ed for STAT, author Erica Rex writes about her experience in a 2012 psilocybin trial and warns that the field is moving away from safety and support in an effort to profit on psychedelics.

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Compass announces promising yet modest results from second Phase 3 trial

On Tuesday, Compass Pathways announced results from COMP006, its second Phase 3 trial using the company’s formulation of synthetic psilocybin, COMP360, for treatment-resistant depression. The results have not yet been peer-reviewed, but according to the company, participants who received two 25mg doses of COMP360 showed a “highly statistically significant and clinically meaningful reduction in symptom severity” compared to participants who received 1mg placebo doses of the drug. Participants’ depression symptoms were assessed using a standard clinical measure of depression called the Montgomery-Åsberg Depression Rating Scale (MADRS). On average, participants who received the two 25mg doses of COMP360 showed a 3.8 point decrease in MADRS scores compared to the placebo group.

These results were nearly identical to those of COMP005, the company’s first Phase 3 trial, in which participants received just one dosing session. Those results were initially reported in June 2025, and in that trial the difference between the 25mg group versus a group that received an inert placebo was 3.6.

At the time, we noted that compared with the company’s Phase 2b results, published in The New England Journal of Medicine in 2022, COMP005’s outcomes were less impressive: in the earlier study, the difference in MADRS scores between the 25mg group and 1mg group was, on average, 6.6 points, nearly twice that of what the company reported for both of these Phase 3 trials.

In a post on X, UCSF researcher Balázs Szigeti noted that Compass had modified its definition of “clinically meaningful” in COMP006’s results compared to earlier studies. In this most recent announcement, Compass defined a meaningful response as a greater than 25% decrease in MADRS score, but the company has previously used 50% as their criteria in reporting data from pilot studies and its Phase 2B study results. “Virtually all studies measure the ‘response rate’ which is defined as a MADRS reduction of at least 50%, not 25%,” Szigeti wrote. Fellow UCSF researcher Robin Carhart-Harris noted the same thing in an X post: “Odd switch in definition of response criteria here,” he wrote, calling this trial’s response rate “quite underwhelming.” But, he noted, a “25+% drop is clinically meaningful, it’s just inconsistent with the standard criteria for response.”

Still, UCSF’s Szigeti wrote that in his view, the company’s two Phase 3 studies “should be enough for FDA approval.” Similarly, Jerry Rosenbaum, director of Massachusetts General Hospital’s Center for Neuroscience of Psychedelics, told STAT that the data “probably meets the bar for approval,” though “it doesn’t shout out to you that this is miraculous.”

Compass’s stock price has increased by some 30% since the company announced their results on Tuesday.

Missouri hearings on ibogaine and psilocybin bills, New Hampshire psilocybin bill advances

On Monday, the Missouri Emerging Issues committee held a hearing to discuss House Bill 2961, a bill that proposes the state’s Department of Health and Senior Services award grants to study ibogaine in the treatment of opioid use disorder, substance use disorder, or “any other neurological or mental health condition for which ibogaine demonstrates efficacy.” The bill states that money for this research could come from private sources as well as the federal government, and would be put in an “ibogaine study fund,” and the state would receive a stake in the intellectual property and commercial rights of any drug that comes out of the research.

At the hearing, all attendees who spoke did so in favor of the bill. Among them were first responders and veterans who talked ardently about how receiving ibogaine treatment in Mexico saved their lives or “cured” them of a range of issues, from PTSD and depression to back pain. Many of these testimonies were moving and tearful; though speakers were limited to two-minute speeches, the committee allowed one particularly passionate speaker to keep talking for more than 10 minutes.

Over a dozen people submitted written testimony ahead of time, including psychedelic non-profit VETS’s legislative director Logan Davidson (who lives in Texas and has worked on psychedelics legislation in the state), and members of the Modern Health Coalition, which one member described as “a Missouri-based organization dedicated to advancing legislative and regulatory policies that support responsible psychedelic research, education, and clinical trials.”

Just three people opposed the bill. Two were registered lobbyists with the Missouri State Medical Association; the other took issue with the bill’s dependence on federal approval for ibogaine to make the drug accessible at the state level, and raised questions about what happens if disputes arise over intellectual property interests.

This week, Missouri lawmakers also took up House Bill 1717, which would allow people with PTSD, major depressive disorder, substance use disorder, or a person receiving end-of-life care to take psilocybin under supervision of a licensed medical professional. Missouri’s Emerging Issues committee also heard testimony about the bill in their Monday session. The bill’s sponsors, Republican State Representative Matthew Overcast and Richard West, also introduced the ibogaine legislation above. “There’s nothing more American than the ability to choose which medication works for you,” Overcast said, after asserting that pharmaceutical companies had no incentive to cure mental illness.

Meanwhile in New Hampshire, the state house passed HB 1809, which proposes initiating a medical psilocybin program run by the state’s Department of Health and Human Services. Earlier this legislative session, representatives declined to advance HB 1796, a similar bill that went into much greater detail about the potential program’s parameters. The less specific HB 1809 now heads to the House Finance Committee for review; should that committee approve it, it will head to the full State Senate for a vote.

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Helus’s DMT formulation shows promise in treating depression

A new study published in Nature Medicine suggests that a formulation of the psychedelic compound DMT could help treat moderate to severe depression. In the Phase 2a study, a group of researchers primarily affiliated with Imperial College London and Small Pharma (a UK-based biotech company that has since been purchased by Helus, formerly known as Cybin) gave 34 adults with depression either a single dose of intravenous DMT — its proprietary formulation, which it calls SPL026 — or a placebo. The IV infusion took 10 minutes, and participants were accompanied by two therapists to provide what the authors characterize as “silent, attentive support.” Compared to other classic psychedelics such as psilocybin or LSD, DMT trips are generally fairly short; when injected, the drug’s effects can wear off within minutes. The researchers assessed participants’ depression symptoms before the DMT dose, then one and two weeks after the dosing session. After a week, participants who received DMT scored on average 10 points lower on the MADRS compared to those in the placebo group; after two weeks, that difference was 7 points.

At the two-week mark, participants were able to receive a second dose of DMT. This time, all participants knew that they were receiving the drug (researchers call this kind of study an open label design). The researchers again assessed participants’ depressive symptoms at 3, 4, 6, and 14 weeks. Those who were originally in the DMT group — meaning they’d received two doses of the drug — showed little additional change in their Montgomery-Åsberg Depression Rating Scale score in the weeks immediately following their second dose, but those who were in the placebo group showed a significant decrease in MADRS score following their DMT dose. The authors interpreted these results to mean that just one dose is effective in decreasing depressive symptoms; the second dose didn’t further improve participants’ depressive symptoms.

The day after the paper was published, Helus’s share price jumped around 15%.

The company is no longer continuing to study intravenous DMT, it says in a press release, but these results will inform the company’s development of HLP004, an intramuscular formulation of DMT the company is studying as a potential treatment for generalized anxiety disorder.

Compass laying groundwork for COMP360 trigger law in Vermont

Tess Bettler, associate director of government affairs at UK-based pharmaceutical company Compass Pathways, presented to the Vermont Senate Committee on Health and Welfare on Wednesday morning. The hearing took place in a charmingly intimate room in the Vermont State House; Bettler was the last speaker in the meeting, and she explained that Compass’s synthetic formulation of psilocybin, COMP360, showed promise in treating depression and that the company would soon be seeking approval for the drug from the Food and Drug Administration. “We are asking for your help to ensure that patients have access to this innovative treatment, in the event it is FDA-approved and rescheduled by the Drug Enforcement Administration,” Bettler read from written testimony submitted ahead of the committee meeting. Bettler also explained that in order to prescribe the drug, Vermont would need to pass legislation to add it to the list of the state’s regulated drugs, and along with her testimony, Bettler submitted draft language for that state legislation.

That language specifically names “crystalline polymorph psilocybin,” which refers to Compass’s proprietary formulation called COMP360. Over the last year, Compass has introduced similar bills in at least ten states; Bettler herself testified in Kansas and Pennsylvania.

The committee seemed receptive to the idea of allowing psilocybin use; one lawmaker said she was “in favor of exploring alternative therapies under the watchful eye of a practitioner, of a therapist and a doctor.” None of the lawmakers indicated that they were aware that this draft language applies only to the company’s formulation of the drug.

• Canadian writer Sheila Heti sets out to try several forms of psychedelic therapy and reports back on the experience for Granta.

• In Q4 of 2025, psychedelic drug developers continued to invest in paying lobbyists, with Compass leading the bunch with $100,000 of spending, reports Psychedelic Alpha.

• MAPS just announced it will be holding the next Psychedelic Science conference in Denver again in May 2027.

• Oregon Health & Science University announced it received a five-year, $3.3 million grant from the National Institute on Drug Abuse (NIDA) to study the safety and effectiveness of Oregon’s state-regulated psilocybin program. Shereef Elnahal, who was formerly the under secretary for Veterans Affairs and has spoken openly about his enthusiasm for psychedelic drugs, is now OHSU’s president.

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More ibogaine bills in Tennessee, Maryland and Vermont

Another three states are considering ibogaine bills this week. Ibogaine is a psychedelic substance made from a shrub native to Central Africa which researchers and advocates are interested in as a potential treatment for opioid use disorder, other substance use disorders, and other mental health conditions. So far, at least ten states have introduced ibogaine-related bills; many reference Americans for Ibogaine, a national consortium of ibogaine advocates co-founded by former Republican Texas Governor Rick Perry which helped secure $50 million for ibogaine research in Texas last year.

Last week, Tennessee State Senator Page Walley (R) introduced SB 2149, also known as “Helping Open Pathways to Effective (HOPE) Treatment Act,” which would create a state fund called the Tennessee Mental Health Innovation Fund by leveraging public-private partnerships to fund ibogaine research. In Maryland, Democratic State Senator Kevin M. Harris introduced SB 527, which would also establish funding for ibogaine research via $1.5 million from the state’s Opioid Restitution Fund, the $670 million the state will receive from prescription opioid-related legal settlements over the next decade or so. In Vermont, a group of six state representatives introduced H0859, which would establish a psychedelic advisory board. According to the bill, this board would be “a step toward Americans for Ibogaine’s goal of establishing ‘the medicalization of ibogaine in the United States — specifically, the successful completion of Phase 3 clinical trials, and ultimately, FDA approval.”

Colorado and New Mexico introduce psilocybin trigger laws

New Mexico lawmakers introduced HB 336, which would make synthetic psilocybin, or any drug containing it, state-legal should the U.S. Food and Drug Administration approve synthetic psilocybin. While roughly half of U.S. states already have laws on the books that would automatically update state law if the federal government reschedules a drug, many do not; last year, at least ten states considered similar trigger laws. Many of those bills were drafted by Compass Pathways, a British pharmaceutical company developing psychedelics as medicines,

and they contain language specifying “crystalline polymorph psilocybin,” the terms the company uses for its proprietary formulation of synthetic psilocybin. However, New Mexico’s law uses the broader term “synthetic psilocybin.”

Last year, Colorado was one of the states that passed a trigger law for “crystalline polymorph psilocybin,” and legislators have now introduced SB 26-031, a broader bill that changes state law if any Schedule I drug is approved for prescription use.

And more psychedelics legislative updates in Washington and Arizona

Last week, Washington’s Senate Committee on Health & Long-Term Care voted 9-1 to advance Senate Bill 5921, a bill drafted by the national group Coalition for Better Community Health, which proposes a medical psilocybin program overseen by the state’s Department of Health. It is now with the Senate Ways and Means Committee. Washington alternates between longer 105-day sessions during budget years, and short 60-day sessions during non-budget years; this is a non-budget year, so all bills must pass the chamber they originated in by February 17. If the Washington State Senate doesn’t vote to advance the bill by next week, it will effectively be dead.

Earlier this legislative session, Washington state lawmakers were also considering Senate Bill 5201 / House Bill 1433, a bill reintroduced from 2025 that proposed a state-regulated psychedelic services program similar to those in Oregon and Colorado and contained a detailed structure for how the program would operate. That bill was not advanced by a committee by a February 9 deadline, and is therefore dead.

Arizona’s SB 1752 prohibits people from knowingly harvesting, processing, or making mescaline for commercial use or research, but it allows use of the substance if used for “bona fide practice of a religious belief.” Mescaline is a compound found in cacti including peyote and San Pedro. The bill specifies that unpermitted mescaline use would be a class 4 felony, which could mean a prison sentence of between 1 and 4 years.

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A death and other troubles at ibogaine centers in Mexico

On January 21, Ambio, an ibogaine clinic with locations in Baja California and in the Republic of Malta, published a statement explaining that a patient died in Mexico while receiving ibogaine to treat addiction through a program Ambio calls its “Detoxification Program.” While the clinic’s post said the company would not discuss details of the incident publicly, its statement suggests the patient could have died due to complications from other drugs. The clinic mentions “the increasing number of dangerous, unknown, and ever-changing adulterants in the global supply of street fentanyl” as a major risk to ibogaine treatment, and mentions it will implement enhanced screening protocols and a minimum 21-day stay for “anyone consuming fentanyl prior to treatment.”

About a week later, Americans for Ibogaine posted a statement saying it was “aware of a serious incident reported by an ibogaine clinic in Mexico involving alleged misconduct by an individual practitioner.” Americans for Ibogaine did not name the clinic, but Transcend Clinic Cancún posted a statement on January 26 saying its staff “detected an irregular situation,” transferred a patient to the hospital, and that the clinic “maintains a zero-tolerance policy toward any form of misconduct.” No details have been made publicly available by the clinic about the nature of the situation or alleged misconduct.

MAPS releases policy guidebook

Last week, MAPS released a policy guide laying out the organization’s priorities and goals amidst a shifting landscape for psychedelics. Founded in 1986, the non-profit has seen — and pioneered — some of the field’s most radical changes. Traditionally, the group was known for its grassroots, anti-establishment approach, bootstrapping funding and researchers to run the world’s first-ever MDMA clinical trials, and supporting people working in the underground.

More recently, the group spun out a for-profit arm of the organization to seek federal approval for MDMA-assisted therapy. After the Food and Drug Administration rejected their New Drug Application in the summer of 2024, the non-profit laid off a third of its employees, and its for-profit arm Resilient (formerly Lykos) also laid off 75% of its employees. At MAPS’s Psychedelic Science conference last summer, the mood was more subdued than in 2023, and panelists and attendees asked: what’s next?

MAPS’s new guide shows the organization wants to take a big-tent approach. It takes care not to alienate psychedelic pharmaceutical companies and those in favor of the medicalization of psychedelics, though it also acknowledges the “practical and cultural limitations of the current healthcare system” and “the need to design, develop, and implement other regulatory approaches.” It notes protecting consumers as a core principle, highlighting the need to limit marketing of psychedelics, and to regulate claims about psychedelic use as “therapy.” “Over the last few years, a tension has emerged in the use of the word “therapy” as a catch-all for any facilitated use,” they write. “It is vital to watch out when lines blur between medical, therapeutic, or other (like adult-use, community or “recreational”) frameworks to ensure people know what they are getting into.”

The organization also weighs in on trigger laws, pointing out that even in states with existing drug rescheduling trigger laws, those laws often only apply to the FDA-approved version of the drug. This is called bifurcated scheduling; for instance, if Compass’s synthetic psilocybin formulation COMP360 were to be approved by the FDA, the DEA would move to reschedule COMP360, but that rescheduling will not apply to all forms of psilocybin, such as the psilocybin found in mushrooms. (For more on bifurcated scheduling, read our interview with regulatory attorney Kim Chew.)

The MAPS policy guide recommends using the broadest language possible in any trigger law — for instance, “any compound, mixture or preparation containing any Schedule I substance upon federal rescheduling or descheduling,” instead of a specific formulation. “By utilizing broad language, states can avoid favoring certain drug producers, as well as the need for additional substance-specific legislation,” they write.

• NFL players are trying psilocybin to recover from traumatic brain injuries, reports The New York Times.

• Psychedelic Alpha’s Josh Hardman interviews Michael Cola, the new CEO of Helus (formerly Cybin) about the regulatory environment for psychedelics and Helus’s priorities in the coming months.

• Harvard’s Psychedelics and Spirituality program lead Jeffrey Breau tells The Harvard Gazette that psychedelic chaplaincy is crucial to supporting people who try the substances. “Patients are having these experiences, and if there is no awareness and specific training on the part of the clinicians or others who are supporting them, then patient outcomes can be harmed,” he told the Gazette. Harvard’s program is studying how psychedelic facilitators are trained and leading workshops for facilitators and clinicians on “spiritually responsive care.”

• The government of Australia has just earmarked $739 million AUD (nearly $524 million USD) to fund well-being activities for veterans, including MDMA and psilocybin for PTSD, according to Australia’s ABC.

• Forbes profiles billionaire financial advisor Ron Carson, whose personal life “frayed” as his business grew. Carson says his psychedelic use (according to Forbes, “he won’t say which one”) helped him reshape his business and to feel more centered. “In 2022, after he hosted indigenous leaders from around the world at his remote hunting lodge–turned–healing ranch, a Lakota chief bestowed on him the name Ta Te Omani, meaning “walking into a stiff wind.” He legally changed his name. Ron would now go by Omani. He gave away all his neckties. He started taking psychedelics and fasting as part of what he describes as a broader effort to heal himself,” Forbes reports.

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State legislative updates in Mississippi, West Virginia, Oregon, and New Hampshire

On Tuesday, Mississippi’s ibogaine bill, SB 2561, failed to advance out of the state Senate’s Public Health and Welfare Committee. (Tuesday, February 3 was the deadline for the House and Senate to advance bills.) Last week, it appeared the bill had momentum after the state House voted 111-1 to pass it. The legislation was one of several ibogaine bills championed by the advocacy group Americans for Ibogaine. It proposed using a portion of the state’s opioid settlement funds, which are expected to total around $421 million over the next 15 years, to study ibogaine.

A similar bill in West Virginia, HB 4626, passed the house last Thursday 96-0. It also proposes funding ibogaine research but through a public-private partnership program. The bill is now with the Senate Health and Human Resources Committee.

On Monday, Oregon legislators introduced HB 4110, a bill that would amend state law to allow physicians to provide ibogaine to patients for PTSD, major depressive disorder, an anxiety disorder, or a substance use disorder. The bill proposes exempting this prescribed use of ibogaine from the definition of “controlled substance” defined by Oregon state law. States generally adopt federal controlled substance guidelines, but some, like Oregon, have made state-specific special exceptions; Oregon has carved out different state policies for psilocybin and cannabis. It now heads to the House Behavioral Health Committee.

The New Hampshire house has rejected one psilocybin bill while advancing another. HB 1796 and HB 1809 both propose a medical psilocybin program run by the state’s Department of Health and Human Services, but the former bill, the one that failed, includes much more detail about the potential program’s parameters, laying out particulars about licensing psilocybin manufacturers and testing products, education requirements for qualified medical providers, and establishing a team of five new employees to run the program. New Hampshire’s House Health, Human Services, and Elderly Affairs Committee voted 11-7 to kill the bill. Meanwhile HB 1809, which has far fewer details — it only says that the health department will develop rules later — passed the same committee 18 to 0.

Fast-tracked federal approval of Compass’s synthetic psilocybin was vetoed

On Wednesday, STAT reported that several anonymous sources told them that the Trump Administration vetoed the U.S. Food and Drug Administration’s suggestion to fast-track Compass Pathways’ drug COMP360 for the treatment of depression. COMP360 is a synthetic formulation of psilocybin.

In July 2025, the FDA began accepting applications for a program called the Commissioner’s National Priority Vouchers; through the program, companies would receive accelerated approval — within 1-2 months — of any drugs that addressed “a large unmet medical need.” At the time, no psychedelic companies stated their intention to apply for the program. The FDA announced it had chosen nine companies for the vouchers in October, including a company called Phlow, which aims to establish a ketamine supply chain in the U.S. According to STAT’s reporting, Compass was meant to be the tenth company; FDA commissioner Marty Makary presented this list of companies to officials in the Health and Human Services Department, who vetoed the FDA’s inclusion of Compass.

STAT did not specifically name which officials were involved in the decision, only referring to them as Makary’s “superiors.” (The FDA commissioner reports directly to the Secretary of HHS, Robert F. Kennedy Jr.) “For some advocates of psychedelic medicines, the last-minute roadblock also underlines an emerging disconnect between HHS Secretary Robert F. Kennedy Jr., a vocal proponent of the field, and other factions of the administration,” STAT reports. It also underscores concerns that the voucher program could be used as a way for high-level politicians or drug companies to interfere with the FDA’s decisions. STAT reported in December that high-level FDA officials have been involved in every part of the voucher program, and “awarded at least one voucher over the concerns of staff.” Additionally, it wrote that the White House “sought to use the FDA program as a bargaining chip, offering the possibility of vouchers to companies like Eli Lilly and Novo Nordisk in exchange for lowering the cost of their blockbuster weight loss drugs,” and that likewise, companies have used the program to “exert pressure on the agency.”

Regardless, Compass is widely believed to be the next company to submit a New Drug Application for a psychedelic treatment to the FDA. In November, the company said they’d accelerated the timeline of their commercial launch by 9 to 12 months, which means the FDA could make a decision on COMP360 in 2027.

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Federal bill proposes VA study psychedelics

In mid January, U.S. Representatives Lou Correa (D-CA) and Jack Bergman (R-MI), co-founders of the Psychedelics Advancing Therapies (PATH) Caucus, introduced H.R. 7091, which directs Secretary of Veterans Affairs Doug Collins to “establish an investigational research and extended access treatment program” which would use “innovative treatments and emerging therapies to address conditions with unmet needs.” Those conditions include chronic pain, PTSD, and substance use disorders, and the clinical trials it calls for specifically includes “psychedelic- and entactogenic-assisted therapies.” (MDMA is often classified as an entactogen rather than a psychedelic.) It’s now been referred to the House Committee on Veterans’ Affairs, where it awaits next actions.

This week, Clearmind Medicine, a psychedelic biotech company, published a statement in support of the bill, calling it “a transformational opportunity for veterans.” Its proprietary drug MEIA, or 5-methoxy-2-aminoindane, is specifically named in the bill alongside ibogaine, ketamine, psilocybin, MDMA, and 5-MeO-DMT.

Definium (formerly MindMed) hit with “trade secret” lawsuit

A Pennsylvania-based company called Signant Health Holding Corp, which specializes in building technology used to run clinical trials, has sued Definium Therapeutics — formerly known as MindMed, a psychedelics biotech company based in New York. Definium, then MindMed, had contracted with Signant to run its Phase 2 trials using their LSD formulation MM120 to treat anxiety and depression. The lawsuit, filed in the U.S. District Court in Delaware, alleges that when Definium contracted with a different company to run its Phase 3 trials, it fed “confidential and trade secret protected” information it had learned from working with Signant.

According to the lawsuit, Todd Solomon, a director at MindMed, worked with former Signant employees and shared information about Signant’s clinical trial design with another company, EMA Wellness, which Definium contracted to run their Phase 3 clinical trials. MindMed “fed those trade secrets to EMA in an effort to shore up EMA’s nascent capabilities and mask EMA’s inability to perform,” the suit alleges. This, Signant alleges, constitutes a violation of trade secret law.

The company announced in January that it was changing its name from MindMed to Definium. In clinical trial results published last fall, its lead drug, a formulation of LSD called MM120, reduced anxiety symptoms.

“We disagree with the claims and will respond through the legal process,” Definium’s vice president of corporate communications Beth Calitri told The Microdose.

An analysis of ibogaine experiences

A great number of bills put forth by the advocacy group Americans for Ibogaine seek provide funding for studying ibogaine as a treatment for veterans’ mental health issues, substance use disorders, and traumatic brain injuries. In a new paper published in npj Mental Health Research, researchers asked 30 veterans open-ended questions about their experiences after taking ibogaine at a 5-day visit to the Ambio Life Treatment Center in Tijuana, Mexico. The authors are all affiliated with Stanford and include the late researcher Nolan Williams, known for his pioneering work on ibogaine.

Many of the veterans interviewed reported re-encountering and reappraising traumatic memories — or as the authors put it: “Traumatic, sometimes previously repressed, experiences replayed with radically altered affect—often suffused with love, forgiveness, and acceptance—leading to catharsis.” Some say they experienced looking at their experiences from outside of themselves, with a “detached, observer-like awareness,” and reconnecting with emotions such as compassion, forgiveness, and love. Some even reported feeling somatic sensations they attributed to being a type of “brain healing.” In the words of one participant, “What was happening in my brain was as if all my neurons and synapses were firing and recharging and healing.” That last idea, in particular, might be a direction for empirical study, the authors say; they theorize that noribogaine, the main metabolite of ibogaine, could elevate serotonin levels and that this increased serotonergic activity could stimulate oxytocin release, leading to feelings of connection.

• The non-profit psychedelic advocacy organization MAPS announced it is partnering with Columbia University to study MDMA-assisted couples therapy. The study will not be a clinical trial, and no MDMA will be administered; rather, the researchers will gather survey data from practitioners who have facilitated MDMA-assisted couples sessions.

• If alcohol and tobacco are exempt from the Controlled Substances Act, psilocybin — ranked by researchers as having the lowest harm on a list of 20 substances — shouldn’t be a Schedule I drug, argue bioethicist Julia Etkin and UC Berkeley law school’s Vincent Joralemon. In a post on Petrie-Flom Center at Harvard Law School website, they make a surprising but cogent argument for why psilocybin should be regulated as a food, not a drug.

• CBS reviews the case of Ameen Alai, who is currently serving a four-year sentence in connection with the death of 54-year old weightlifter Andy Haman, who died after taking ibogaine in Alai’s Colorado basement in 2021.

• On Friday, police in Windsor, Ontario raided the psilocybin dispensary FunGuyz for the ninth time, reports the Windsor Star. Police across Canada have been raiding dispensaries like FunGuyz over the last several years, playing a game of whack-a-mole as the dispensaries continue to re-open after raids. But this time, FunGuyz’s owners say they will be closing the location. During the raid, police found not only psilocybin but LSD, DMT, and crystal meth. “Because of what was found in there, we’ve made the decision to close that location now,” the owner told CTV News.

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The State of Psychedelics: Ibogaine consortium gains steam with new bills in MS and OK; Another psilocybin bill in NJ

The Mississippi house voted 111-1 (with 10 abstentions) last Wednesday to pass Senate Bill 2561, which proposes using a portion of the state’s opioid settlement funds (which are expected to total around $421 million over the next 15 years) to study ibogaine “and secure the United States Food and Drug Administration’s approval of ibogaine as a medication for the treatment of opioid use disorder, co-occurring substance use disorder, and any other neurological or mental health condition for which ibogaine demonstrates efficacy.” Americans for Ibogaine, a national consortium of ibogaine advocates co-founded by former Texas governor Rick Perry, cheered the bill’s progress. “Momentum is building,” the group wrote on LinkedIn. “One state at a time, the path for responsible, FDA-aligned ibogaine research in the United States continues to expand.”

Americans for Ibogaine was established in 2025 and evolved out of an effort by W. Bryan Hubbard, another of the group’s co-founders, who in 2023 was the chair of Kentucky’s Opioid Abatement Advisory Commission. He proposed using $42 million of the state’s opioid settlement funds to study ibogaine, an effort that was ultimately unsuccessful but has expanded into a national strategy. The group’s other co-founders include Marcus Luttrell, a former Navy SEAL whose brother, Morgan, is a Republican Congressman from Texas who is a member of the Psychedelics Advancing Therapies (PATH) Caucus for psychedelic advocacy. Since then, Americans for Ibogaine has made inroads in multiple states. Oklahoma’s legislative session doesn’t begin until next week, but legislators have pre-filed HB3834, a proposal for the state’s department of health to partner with a drug developer to conduct ibogaine clinical trials. If ibogaine were to be approved by the FDA as a treatment, the bill would allow the state to share in any intellectual property profits resulting from the partnership.

It appears Americans for Ibogaine will also be leading or assisting with legislative efforts in Florida, Tennessee, California, and Ohio. In an interview with Seattle alt-weekly The Stranger, State Senator Jesse Salomon, who has been introducing psychedelics bills in Washington State for years to no avail, says he is now taking up ibogaine too. (One of the bills Senator Salomon has introduced this legislative session was drafted by the Coalition for Better Community Health, which includes Americans for Ibogaine’s Hubbard.)

Meanwhile, psychedelics bills are also progressing in other states. New Jersey just passed A3852, which designates $6 million for psilocybin research. Legislators have also introduced another bill, S3148, which would create a state-regulated psilocybin program similar to Oregon’s. Denise Rue, a licensed social worker who raised concerns about A3852 before its passage, told The Microdose that this new bill is similar to an earlier version of A3852, presenting another opportunity for grassroots advocates to advance legislation that provides access to psilocybin outside of a strictly medical model.

Federal psychedelics efforts remain stagnant

When President Trump took office in 2025, some psychedelics advocates were excited about the cabinet he selected that appeared poised to fast-track psychedelics through federal approvals; Health and Human Services Secretary Robert F. Kennedy Jr. said in July that psychedelics would be available within 12 months. Now, more than a year into Trump’s presidency, a trio of recent articles give us a glimpse into what advocates see as a lack of strategy at the federal level regarding psychedelics.

• Psychedelic executives and advocacy groups tell POLITICO they’re disappointed they’ve not seen any progress. “A year into his tenure, Robert F. Kennedy Jr. has yet to expand access to the mind-altering drugs and advocates are starting to lose patience,” journalist Amanda Chu reports.

• Lawmakers are trying to pressure the administration to take action. Two weeks ago, The Mission Within, a veterans psychedelic group, and advocacy group Psychedelic Medicine Coalition, held a forum to advocate for veterans’ access to psychedelics. U.S. Representatives Lou Correa (D-CA), Jack Bergman (R-MI), and Morgan Luttrell (R-TX), all part of the Congressional Psychedelics Advancing Therapies (PATH) Caucus, also joined them. Marijuana Moment reported that Luttrell warned that even a single misstep could jeopardize the movement; Bergman agreed that other members of congress were “risk-averse” about the issue.

• While psychedelics may not be gaining much traction at the federal legislative or agency policy level, FDA Division of Psychiatry Director Tiffany Farchione recently revealed there’s been a glut of psychedelics drug applications. Psychedelic Alpha reports that Farcione spoke at a webinar held by the American Brain Coalition and said that “fully a third of my workload” was reviewing psychedelic investigational new drug applications. Farchione said that the eventual goal was to approve psychedelics so “folks won’t have to go on a retreat in another country to receive these medications.” National Institute on Drug Abuse director Nora Volkow, who also recently penned a blog post on the drugs’ promise, writing that they “represent a potential paradigm shift” in the treatment of mental health conditions.

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Distinguishing psychological “support” from therapy

So far in psychedelics research, most studies have paired a drug with some form of psychotherapy. The types of psychotherapy approaches used in studies vary widely. Complicating matters further, it’s difficult to evaluate psychotherapy’s contribution to psychedelics’ efficacy. Some companies developing psychedelics as pharmaceuticals offer what they call “psychological support” in place of psychedelic-assisted therapy, but what differentiates such support from psychedelic-assisted therapy remains murky. A paper published recently in General Hospital Psychiatry seeks to define those differences.

The authors, all researchers at Johns Hopkins, propose that while psychedelic-assisted therapy (PAT) and psychological support share an emphasis on safety, they ultimately have different aims and require building different types of relationships with patients. Whereas psychotherapy aims to treat a psychological problem, psychological support avoids that. (For example, a therapist might guide a participant through an exploration of their own values or setting intentions as a part of PAT, but a person providing mere support would not.) Similarly, whereas a therapist might explain how their psychological approach could contribute to healing, people providing support would explicitly avoid such a statement as well.

After landing on these distinctions, the researchers then set out to test them by reviewing recent psychedelic studies and comparing the terms those researchers used to describe the care participants received — e.g., “psychological support” or “psychotherapy” — to the assessments of third party raters using their new criteria for “support” and “therapy.” In total, the paper’s authors analyzed 11 studies and found that while the majority called the care their participants received “support,” it appeared that the majority were indeed providing psychotherapy, at least by the authors’ definitions.

The authors emphasize that they are not looking to adjudicate whether one approach is superior to another, only to define their differences. “With shared definitions of psychotherapy and psychological support in hand, the interpersonal interactions that occur in psychedelic administration contexts may be more reliably characterized and more effectively studied,” they write.

Oregon Psilocybin Services closes loophole allowing after-hours events

Last week, the Oregon Health Authority (OHA) announced that it will permanently adopt a temporary rule it first issued late last summer. The rule, OHA said, closes an “unintended loophole”; current law specifies that psilocybin service centers can only sell products and provide services between 6am and 11:59pm, but the law also allows service centers to be used for temporary purposes, for which there are no specified hours. The now-permanent rule change states that psilocybin center activity cannot take place between midnight and 5:59am. “Events that extend beyond 11:59 PM are not consistent with the safe and orderly operation of psilocybin service centers; and they are more likely to involve intoxicated individuals who have consumed alcohol at neighboring businesses,” OHA said in a report summarizing the changes and public comment received about the proposed change.

According to the report, the OHA appears to have received only one letter opposing the change, calling the cutoff of 11:59pm “arbitrary,” and disagreeing that there are additional risks with late-night operations. In oral testimony, the agency wrote, others testified that the rules covering these temporary evening events “are reactionary and are informed by anxiety and fear, similar to the same feelings that were present about psilocybin when the Act was passed in 2020.”

• Placebo is a part of pretty much any medical treatment, including psychedelics. For Slate, I explore the history of placebo, several recent psychedelics studies that attempt to assess the contribution of expectation, and whether it’s possible to leverage the power of belief in a medical system built on western science.

• In Rolling Stone, journalist Mattha Busby tells the harrowing and surprising story of an ayahuasca trip that ended with the brutal stabbing of an ayahuasca maestro by a client.

• On NPR’s Planet Money reporter Alexi Horowitz-Ghazi takes listeners inside the Zide Door, an Oakland-based church which claims to be the world’s largest psychedelic church. (This work was supported by a Ferriss - UC Berkeley Psychedelic Journalism Fellowship; applications are currently open through Sunday.)

• According to The Washington Post, the FBI is investigating a California doctor in the death of former Indianapolis Colts owner Jim Irsay. The doctor, Harry Haroutunian, reportedly provided Irsay with ketamine and other painkillers.

• Former French Senator Joël Guerriau is currently on trial after allegedly spiking a glass of champagne with MDMA and serving it to Sandrine Josso, another member of parliament, reports The Guardian. Josso says the concoction was a prelude to sexual assault; Guerriau claims it was an accident.

• Washington Post columnist Leana Wen warns readers against taking products claiming to contain Amanita muscaria.

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RAND estimates millions of Americans microdosed psychedelics in 2025

In a new report, the RAND Corporation estimates that about 10 million U.S. adults microdosed psilocybin, LSD, or MDMA in 2025. The figure is based on the thinktank’s survey of a nationally representative group of 10,122 adults in the U.S. about their drug use, and scaling those figures to the entirety of the U.S. population. If their estimates do in fact represent the national prevalence of microdosing psychedelics, microdosing is hugely popular in the U.S.. While many people have anecdotally reported experiencing benefits from psychedelic microdoses, and studies surveying microdosers about their subjective experiences typically report that people who microdose say they feel more creative or in a better mood after microdosing. Recent placebo-controlled trials that have found the effects of microdosing may be no greater than those of placebo.

In addition to disclosing their microdosing use, participants in the RAND survey also reported taking a variety of psychedelics in the last year. Psilocybin — both mushrooms and synthetic — was the most popular, followed by MDMA and its chemical cousin MDA, and, surprisingly, Amanita muscaria in third. Amanita muscaria, a mushroom that contains the psychoactive compound muscimol, is not a traditional psychedelic, but it’s known to produce somewhat unpleasant trips, according to Kevin Feeney, an Amanita expert and anthropologist at Central Washington University we interviewed in 2024. The RAND Corporation report did not include details about where survey participants were sourcing their drugs; Amanita is frequently advertised as an ingredient in mushroom chocolates or candies, but such edibles are often mislabeled.

New Jersey to commit $6 million to psilocybin research; new bills in New Hampshire and Iowa; grassroots group in Washington State suggests amendments

On Tuesday, New Jersey Governor Phil Murphy signed bill S2283, which will provide $6 million from the state’s general fund for a two-year pilot program to conduct psilocybin research. Psychedelics veterans group VETS hailed the bill’s passage as a victory. Two of the organization’s grant recipients testified in favor of the bill, and it becoming law is a testament to the growing power of veterans groups in U.S. psychedelics legislation. VETS also threw its weight behind an initiative which secured $100 million for ibogaine research in Texas in 2025.

New Hampshire legislators are considering two psychedelics bills: HB 1796 and HB 1809, both of which propose a medical psilocybin program run by the state’s Department of Health and Human Services. The former bill includes much more detail about the potential program’s parameters, laying out details about licensing psilocybin manufacturers and testing products, education requirements for qualified medical providers, and establishing a team of five new employees to run the program. The latter bill includes far fewer details, merely tasking the health department with adopting rules later.

Last Thursday, legislators in Iowa introduced HF 2085, which would allow people to “recommend, possess, use, dispense, deliver, transport, or administer psilocybin” if the psilocybin is produced and administered in compliance with state-approved policies. The lengthy bill includes detailed standards for the potential program, which would include establishing a licensing board to review applications for psilocybin cultivators and qualified medical providers.

And in more state news, as we reported last week, legislators in Washington state are considering two bills: Senate Bill 5201 / House Bill 1433, which proposes a state-regulated psychedelic services program similar to those in Oregon and Colorado, and Senate Bill 5921, drafted by the national group Coalition for Better Community Health, which proposes a medical psilocybin program overseen by the Department of Health. Grassroots psychedelic advocacy group REACH WA released a statement this week outlining the strengths and shortcomings of both bills, along with recommendations for amendments. The group raised concerns that SB 5921’s medical framework and its “extensive regulatory requirements” would make it difficult for people to receive care - and that its standards are designed for the development of synthetic psilocybin. The organization recommends the bill be amended to allow for protections and use of “natural” psychedelics. REACH WA also recommends those protections for SB 5201.

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Most Americans still feel neutral to negative about psychedelics

In other polling data, a survey conducted by analytics company Ipsos and the news and analysis site Psychedelic Alpha found mixed attitudes among U.S. adults towards psychedelics. The survey included a nationally represented group of over 1,000 Americans, conducted over three days in November 2025. Of that group, 44% had neutral or mixed opinions about psychedelics being used in mental health care, while the rest were split between expressing positive (28%) and negative (28%) attitudes.

The survey also revealed that 7 in 10 people had not seen any psychedelics media coverage over the last 90 days — but that among people who had seen information about psychedelics, the majority reported seeing positive information about the substances. Unsurprisingly, of that group, those under 35 were most likely to have seen psychedelics information on social media, whereas those over 65 said they had encountered it in news broadcasts or newspapers.

New Mexico medical psilocybin program committees announced

New Mexico’s psilocybin program is getting underway, with the established goal of being available to the public in one year. Last Thursday, the state program announced meeting times for its new advisory board committees. During Oregon and Colorado’s psilocybin program roll-outs, the committees’ foci were representative of the burgeoning programs’ priorities and needs. New Mexico’s committees also give us a glimpse into what its state leaders are paying attention to. The current committees include:

• Patient qualification and safety: responsible for recommending which medical conditions could benefit from psilocybin treatment and establishing patient safety and exclusion criteria.

• Dosage, administration, and clinical practice: responsible for developing recommendations for dosing, therapeutic structure, and protocols.

• Education and training: responsible for recommending required training and education for practitioners.

• Research and continuous improvement: responsible for developing guidelines on data collection and harm reduction practices.

• Propagation: responsible for developing best practices for cultivating, handling, and testing psilocybin mushrooms.

• Equity, access, and cultural considerations: responsible for ensuring access to “rural, frontier, and underserved areas [of] New Mexico, including but not limited to telehealth-enabled screening and rural training.”

• End of life: responsible for developing recommendations for safety criteria and coordination to allow end-of-life patients to access psilocybin.

• Over the last year, former Arizona Senator Kyrsten Sinema has devoted herself to ibogaine advocacy. She is now being sued by the ex-wife of her bodyguard Matthew Ammel for allegedly encouraging him to leave his family. The suit alleges Sinema paid for Ammel to receive psychedelic therapy and encouraged him to bring MDMA on a work trip so she could guide him through a trip. In a piece called “More than you want to know about Kyrsten Sinema’s alleged psychedelic affair,” Ecstatic Integration’s Jules Evans details Sinema’s and Ammel’s recent psychedelic connections.

• Monica Schweickle, founder of Australian firm The Psychedelic Consultancy, joins Psychedelic Alpha in reviewing Australia’s grand experiment allowing psilocybin and MDMA treatment. While a Freedom of Information request revealed that zero severe adverse events had been reported across over 130 patients, there are other concerns: treatment still remains extremely expensive, and many are calling for more inclusion of Indigenous therapists to ensure culturally responsive care.

• The Denver Department of Public Health & Environment has removed PolkaDot brand chocolate bars from several Denver retailers, reports the city’s alt-weekly Westword. According to the public health department, the bars contained psilocybin and psilocin, as well as 4-ACO-DET, 4-HO-DET, and 4-HO-MET, all of which are not federally scheduled but are known as psilocybin analogs that produce psychoactive effects.

• Law enforcement in Europe has conducted a massive drug ring bust, arresting more than 85 people operating 24 labs across multiple countries that manufactured methamphetamine and MDMA, according to CBS News.

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The State of Psychedelics: Updates in WA and NJ

Washington State’s legislative session kicked off this week, and numerous psychedelic bills are in the mix. Senate Bill 5201 and House Bill 1433 both propose a state-regulated psychedelic services program similar to those in Oregon and Colorado. The same bills were introduced in the 2025 legislative but neither moved forward and so they’ve been reintroduced.

A third bill, Senate Bill 5921 also proposes a psilocybin program, but one that would be overseen by the Department of Health and focused on medical use only. The bill was drafted by the Coalition for Better Community Health, which includes Tom Eckert, one of the architects of Oregon’s psilocybin services ballot initiative, University of Washington psychedelics researcher Nathan Sackett, Americans for Ibogaine’s Bryan Hubbard, and Healing Advocacy Fund’s executive director Taylor West. The bill was proposed by Jesse Salomon (D), who also proposed SB 5201.

Meanwhile, local advocacy group REACH WA is also trying to get another psychedelics bill off the ground in Washington State. Their draft bill, for which the group is currently seeking a sponsor in the legislature, would allow people over 21 to access services to support natural psychedelic use, allow personal possession, use, cultivation, preparation, and gifting of psilocybin, psilocin, DMT, and mescaline (excluding peyote), establish rules about advertising such services, and require psychedelic businesses to retain majority Washington state residency through 2029.

On Monday, the last day of its legislative sessions, the New Jersey Senate passed bill S2283, which will provide $6 million from the state’s general fund to a two-year pilot program to conduct psilocybin research. The bill passed the assembly 48-23, then the senate 35-4. It now awaits a signature by Governor Phil Murphy.

At a New Jersey State Assembly Appropriations Committee hearing about the bill in December, members of the public raised concerns that the allotted $6 million would end up going to psychedelics companies conducting clinical trials with synthetic psilocybin (i.e., Compass Pathways, which is already partnering with New Jersey healthcare system Hackensack Meridian). People were also worried that the bill’s language did not explicitly mention preparation and integration sessions for study participants. The final version of the bill has amendments that explicitly include integration and require applicants for the research grants to include hospitals from each region of the state.

MindMed and Cybin rebranding

On Monday, New York-based psychedelic company Mind Medicine, known as MindMed, announced it would be changing its name to Definium. Definium also announced that it expected topline data from two Phase 3 clinical studies using DT120 — their formulation of LSD, which takes the form of an oral disintegrating tablet — in treating generalized anxiety disorder, as well as data from a Phase 3 study using DT120 to treat major depressive disorder.

MindMed isn’t the only psychedelics company to rebrand in the early days of the new year. Psilocybin company Cybin announced last week that it would be changing its name to Helus, pronounced “Heal Us,” and would be trading on the Nasdaq with the ticker symbol HELP.

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Psychedelic retreat safety protocols vary

As psychedelics have become more popular, so, too, have retreat centers offering guided trips. A new study spearheaded by bioethicists and health policy scholars studied the safety precautions put in place by 49 psychedelics retreat organizations in the Americas. The results were published recently in JAMA Network Open.

Of the 49 organizations the researchers interviewed, all reported collecting client medical histories and including integration sessions in their practices. All but one shared the names of the substances they offered; those 48 organizations all provided ayahuasca, psilocybin, or both, and some also provided ibogaine, 5-MeO-DMT, San Pedro cactus, or DMT.

The screening practices of the organizations were variable. Thirty-six of the 49 organizations said they excluded individuals with certain health conditions, and 32 provided specifics about grounds for exclusion, including mental health disorders like a personal or family history of schizophrenia or psychosis, heart conditions like hypertension, and neurological conditions like stroke or epilepsy. Six said they explicitly exclude pregnant people, and five presented exclusion criteria that the researchers labeled as “other,” which comprised a varied list, including AIDS, cancer, eating disorders, IBS, asthma, recent surgery, and a history of blood clots. Forty-three of the 49 organizations said they required or recommended clients stop taking medications like SSRIs before the retreat, but the methods by which they confirmed that client compliance varied.

Only about half (21 of 49) of retreat organizations said they worked with at least one licensed healthcare professional, such as a physician, nurse, or therapist; and 20 of the 49 said they had such a professional present at retreats.

Overall, the researchers say that the variability in standards across these 49 organizations suggests the need for clearer guidance on safety practices. “While many retreat organizations implement thoughtful safety practices, substantial variability and lack of oversight remain,” they write. “Consumers and health care professionals must navigate this landscape with caution.”

Are psychoplastogens “sanitizing” psychedelics?

There is still no scientific consensus on how, exactly, psychedelics might improve mental health, but there is a well worn divide in the field: some believe the subjective experiences that psychedelics engender — the trip — are crucial to healing, while others that these subjective experiences are not necessary for therapeutic benefit. Some who champion the latter theory are now engineering so-called psychoplastogens: drugs that are chemically similar to psychedelics, but that mostly skip the trip.

In a new paper published in BioSocieties, Bar-Ilan University scholar Ido Hartogsohn argues that the emergence of psychoplastogens has “begun to reshape how psychedelics are framed.” Now, he says, classic psychedelics like psilocybin or LSD are called “first-generation psychoplastogens” to contrast them with the “newer, purportedly more controllable and clinically tractable” drugs that are developed and marketed as “second- or third-generation psychoplastogens” by companies like Delix.

Furthermore, he writes, while psychedelics are associated with inner work and transformative experiences, psychoplastogens “exemplify a drive toward optimization without disruption, a form of experiential sanitization that tames unpredictability while extracting benefits.” Essentially, Hartogsohn argues that non-hallucinogenic psychoplastogens represent the desire to take a shortcut to healing without undergoing the potential difficulties and soul-searching that can accompany a psychedelic trip — and those values could set a dangerous precedent for mental health care in general. “At stake is not merely whether subjective experience is therapeutically necessary, but the nature of mental suffering, what kind of healing is valued, and what kind of subject it is meant to produce.”

• Journalists: Applications are now open for ten $10,000 awards to report in-depth print and audio stories related to psychedelics. Applications for the Ferriss – UC Berkeley Psychedelic Journalism Fellowship are due January 31.

• The New York Times reviews the growth of state-regulated psilocybin programs and the potential for Compass to become the second company to apply for Food and Drug Administration approval of a psychedelic treatment.

• Psychedelic Alpha’s Josh Hardman asked people across the psychedelics field (including yours truly) what they’re excited about, concerned by, and hoping to gain clarity on this year.

• Some psychedelics journalists are increasingly stepping into an influencer role, where they’re offered free access to retreats and deals to receive sponsorships or affiliate deals — a “troubling trend,” writes journalist Jim Tate in a Substack essay republished by Lucid News. “These relationships can create subtle (or overt) pressure to present psychedelics in a positive light, downplay risks, or ignore negative findings.”

• On Monday, the Ohio State University’s Center for Psychedelic Drug Research and Education held its first in-person training for therapists through its Psychedelic Emergency, Acute, and Continuing Care Education program. The event included training for how to handle a person undergoing a psychedelic crisis, reports Spectrum News.

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Compass Pathways partnering with mental health clinic chain Radial Health

On Tuesday, the British psychedelics company Compass Pathways announced that it will begin a partnership with Radial Health, a mental health company developing a network of clinics across the U.S. These clinics provide treatments including transcranial magnetic stimulation and esketamine and seek insurance reimbursements for them. The company currently lists clinics in midtown Manhattan, Chattanooga, Tennessee, St. Louis, Missouri, Conway and Myrtle Beach, South Carolina, and virtual care in other states. “We’re proud to collaborate with Compass to help ensure that its innovative, science-based treatment, if approved, reaches patients,” Radial’s CEO and co-founder John Capecelatro wrote in a LinkedIn post announcing the collaboration.

Last summer on a panel at Psychedelic Science 2025, Compass CEO Kabir Nath as well as Doug Drysdale (formerly CEO of Cybin) and former Lykos CEO Amy Emerson discussed developing psychedelic treatment infrastructure as an important next step for psychedelic companies. “They floated the idea that the process of getting psychedelic treatment might become similar to dialysis or Botox for migraines — a doctor prescribes it to a patient and educates them about what to expect before treatment, but clients go to a separate clinic for the actual treatment,” I wrote then. Radial’s clinics provide a similar boutique clinic environment, as well as the potential for working with insurance companies for reimbursement.

The company also announced on Wednesday that COMP360, its formulation of synthetic psilocybin, received Investigational New Drug status from the U.S. Food and Drug Administration to treat PTSD. Compass will now begin Phase 2b and Phase 3 clinical trials.

FDA lifts clinical hold on GH Research’s synthetic 5-MeO-DMT

On Monday, Dublin-based biopharma company GH Research announced that the U.S. Food and Drug Administration lifted a clinical hold on its drug GH001, a synthetic inhalable form of 5-MeO-DMT. The FDA initiates clinical holds if they believe there are safety concerns, lack of information, and/or flaws in the study design. In GH’s case, the FDA had concerns about the company’s inhalation device, and GH001 had been on clinical hold for more than two years.

Last summer, GH Research announced that they had officially submitted a response to the FDA’s concerns, which included additional studies examining how its inhalation device affects the respiratory tracts of dogs and rats, but the FDA again requested additional data. GH’s recent announcement did not include information about what data resolved the FDA’s remaining concerns, but heralded the decision as “a major milestone” that will allow the company to move forward with designing Phase 3 trials for GH001, which is being studied as a medication for treatment-resistant depression.

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DEA ups drug quotas for psilocybin, psilocin, and DMT research

On Monday, the U.S. Drug Enforcement Administration published a notice to the Federal Register updating 2026 quotas for drugs to be manufactured for research. The quotas for most psychedelics remained the same as those announced in November, but the updated quotas include increases for psilocybin, psilocin (the active metabolite of psilocybin), and DMT, which were already significantly increased compared to 2025 numbers.

DEA extends telemedicine policy for yet another year

On the last day of 2025, the U.S. Drug Enforcement Administration posted in the Federal Register that it would extend its telemedicine policy through the end of 2026, offering another year of runway for mail-order ketamine companies.

During the COVID pandemic, the federal government declared a public health emergency which allowed physicians to prescribe many drugs, including ketamine, after a telehealth consultation rather than an in-person appointment. In 2023, the DEA continued that policy through a “temporary” rule, which it has now renewed for a fourth time.

For companies that offer mail-order ketamine, the continued extension has been a key element for business. But the last year has seen difficulties in that sector, with at-home ketamine start-up Noma shuttering, and telemedicine ketamine company Mindbloom facing a wrongful death suit brought by the family of a 27-year-old who received ketamine from the company.

Qualitative experiences from a Compass psilocybin clinical trial

While many psychedelic studies released in the 2020s have focused on quantifying the efficacy of psychedelics in treating clinical symptoms of mental health disorders, the field is now turning more of its attention to variables that are more difficult to quantify, like the contribution of therapeutic support and participants’ subjective experiences. In a paper published in eClinicalMedicine, an open-access digital-only journal published by The Lancet, researchers who worked on Compass Pathways’ clinical trials review lessons from participants. Those participants had been diagnosed with PTSD and were given COMP360, the company’s formulation of synthetic psilocybin, in an open-label Phase 2 trial.

The researchers conducted interviews with 21 participants, and they reported four major themes. One was the factors that gave participants a sense of psychological safety and trust, which included intention-setting and receiving education about what they might experience before dosing. This is particularly noteworthy given concerns that preparation sessions could be phased out of some psychedelic treatments to cut costs. For instance, advocates recently raised concerns about a medical psilocybin program proposed by New Jersey assemblymembers and backed by veterans groups that did not include language about preparation and integration. Participants also talked about how the treatment actually felt to them — several mentioned the somatic experience, such as increased bodily awareness or even the sense that psilocybin was “repairing the nerves in the body.” While some participants had a positive somatic experience, others said it hurt.

Other themes included whether participants felt like they engaged directly with their trauma during their dosing sessions, and comparing their psilocybin experience to other treatments they’d tried. Overall, the researchers say, the participants’ accounts drive home how intense and ineffable psychedelic experiences can be, and the need for strongly informed consent to participate in such trials.

• The Guardian covers the rise of psychedelic churches in the U.S., from the Church of Gaia — a Spokane church that received a DEA exemption last year to serve sacramental ayahuasca — to Singularism, a Utah church suing the state for seizing its psilocybin mushrooms in 2024.

• When bees collect nectar from rhododendrons, they create honey that contains grayanotoxins, a natural compound that can produce hallucinations and is used by Indigenous Himalayan communities as a natural medicine. Members of those groups scale cliffs to collect this “mad honey,” and its popularity has grown after “podcast bros” like Joe Rogan have mentioned it, writes journalist Saugat Bolakhe in a piece co-published by The Xylom and The Himalayan Times. Mad honey harvesting is legal in Nepal, but ingesting the substance has caused serious illness, Bolakhe reports, and the increased demand is incentivizing disrespectful and dangerous mad honey harvesting.

• Toronto-based biomed company Psyence announced on Monday that it is now producing “high-purity ibogaine hydrochloride (ibogaine HCl) derived from a naturally extracted, ethically sourced supply in Africa,” compliant with good manufacturing practices.

• Bloomberg reports on Compass’s planned 2027 synthetic psilocybin launch and says the company “expects to file with US regulators” in 2026.

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AtaiBeckley patents R-MDMA formulation

AtaiBeckley announced last week that the U.S. Patent and Trademark Office granted the company a patent for EMP-01, a formulation of oral R-MDMA. MDMA is typically a “racemic mixture”: it contains an equal proportion of two molecular structures, known as R-MDMA and S-MDMA, which are mirror images of each other; EMP-01 is a formulation of R-MDMA.

Previous research has suggested that while S-MDMA is associated with strong visual effects and higher blood pressure, R-MDMA more strongly activates serotonin receptors. AtaiBeckley says EMP-01 has been “generally found to be more similar to classical psychedelics than to racemic MDMA.” In its announcement, the company said it would release preliminary data from a phase 2a study using EMP-01 to treat social anxiety disorder in the first months of 2026.

Other companies are also looking to bring R-MDMA to market. In October, a San Francisco-based company called Arcadia received Investigational New Drug status from the Food and Drug Administration for its R-MDMA formulation, which it calls AM-1002. Arcadia is also studying its R-MDMA formulation in the treatment of anxiety. The New York-based company MindMed also has an R-MDMA research program, investigating its use in people with autism spectrum disorder.

California issues shrooms edibles warning

The California Department of Public Health published a statement last week warning consumers to stay away from products claiming to contain magic mushrooms made by a brand called TRE House. According to the department, the brand’s gummies, chocolate bars, and syrup contain a drug called 4-acetoxy-DET, and some contain 4-acetoxy-DMT, both of which are analogs of psilocin. (Psilocybin is the prodrug of psilocin; when a human ingests psilocybin, it’s metabolized into psilocin.)

According to the statement, California authorities are investigating TRE House. No illnesses have been reported yet, but the Department of Health writes that “these food products have the potential to cause severe adverse health effects, including hospitalization and even death.” Last year, the CDC warned consumers to stay away from another brand of synthetic psilocybin edibles called Diamond Shruumz after 180 cases of illness, including 3 potentially associated deaths, were reported; some of those products also contained 4-acetoxy-DMT, along with other substances.

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Difficulties following naturalistic psychedelic use associated with having adverse childhood experiences

People with adverse childhood experiences have higher rates of difficult psychedelic trips, according to a new study published in the International Journal of Drug Policy. An international group of researchers used data from a 13,000-person study of naturalistic drug use and meditation. From that group, around 3100 respondents said they’d used psychedelics, and those data was analyzed for this study. Respondents also filled out a questionnaire to assess how many adverse childhood experiences (ACEs) they’d experienced, a measure that includes household dysfunction and abuse.

Overall, 88% of respondents reported no psychedelic difficulties, while 12% reported experiencing difficulties — including 40 people who said their difficulties lasted a year or longer. Those that reported difficulties after trips were also more likely to have had adverse childhood experiences. The authors note that while it’s not possible to infer causality — i.e., whether those childhood experiences caused those difficult psychedelic experiences — “ACEs may represent a psychedelic-specific risk,” such as heightening autobiographical recall or the resurfacing of forgotten or repressed traumatic memories. Given that psychedelics are increasingly being researched as a way to heal from emotional trauma, these results suggest that more research may be needed to explore the relationship between childhood traumas and psychedelic difficulties.

The State of Psychedelics: Updates in New Jersey, Alaska, Texas, and Ohio

On Thursday, New Jersey’s Assembly Appropriations Committee discussed A3852, a bill that would appropriate $6 million to establish a two-year pilot program to conduct psilocybin research, overseen by the state’s health department and an 11-person advisory board. When it was initially introduced in 2024, the bill proposed a state-regulated psilocybin program like Oregon’s, but the health committee proposed this amended version, which passed in late November 2025.

During the hearing, five out of six people spoke to oppose the bill during the committee’s public comment period. Neal Usatin, a filmmaker who edited the Netflix docuseries How to Change Your Mind, raised concerns that the bill leaves “too much room for interpretation as to how the pilot program will be set up, who will design the pilot programs, and who will benefit.” Usatin said he was worried that the state funds would go to companies’ Phase 2 or 3 clinical trials using synthetic psilocybin to treat patients, and that the bill focuses only on behavioral health issues rather than a wider range of conditions like chronic pain and cluster headaches.

Denise Rue, a licensed clinical social worker and founder of the New Jersey Psychedelic Therapy Association, also raised concerns that the psilocybin used in this potential research would be synthetic formulations rather than whole mushrooms. (For context, Compass Pathways is already partnering with New Jersey healthcare system Hackensack Meridian to use COMP360, its formulation of synthetic psilocybin in research.) Additionally, Rue pointed out that the bill’s current language removes preparation and integration sessions from psilocybin treatment. “This is not a pill that we give people like an antidepressant. If we remove that language, we remove the guardrails and we put patients at risk,” she said. She also questioned whether spending $6 million was a good use of funds when there was already data available from other clinical trials and people treated through state programs like Oregon’s.

Lisa Swain, chair of New Jersey’s Assembly Appropriations Committee, said she viewed the bill as “a first step,” and that the advisory committee would have the latitude to make determinations about what type of psilocybin is used in studies and other details of the program. Ultimately, it passed the committee 6 to 5, and now heads to the full assembly for a vote. The bill has a short runway to pass; the state’s legislative session ends on January 12, 2026.

Last week, Natural Medicine Alaska announced that the psychedelics ballot initiative that they were collecting signatures for would not qualify for the state’s 2026 ballot. “We came incredibly close, but limited funding ultimately made it impossible to reach the required signature threshold in time,” the group’s leaders wrote in a Facebook post.

According to Alaska’s guide to the ballot initiative process, petitioners must collect signatures “equal in number to 10% of those who voted in the preceding general election” — which, per the state’s records, is roughly 34,000 signatures. The Microdose reached out to Natural Medicine Alaska for comment but did not receive a reply by press time.

In June, Texas passed a bill allocating $50 million to research on the therapeutic potential of ibogaine, a psychoactive substance found in plants including the iboga bush. The legislation directs the state to create a public-private partnership to fund a clinical trial that uses ibogaine to treat opioid use disorder, other substance use disorders, and “any other neurological or mental health conditions for which ibogaine demonstrates efficacy.” At the bill’s signing ceremony, Texas Senator Tan Parker, a Republican and one of the bill’s sponsors, said that within the next 60 days, Texas authorities would begin evaluating trial proposals from universities, hospitals, and drug developers.

This week, those authorities announced that UTHealth Houston and University of Texas Medical Branch at Galveston would lead a two-year research trial, and that they would also be collaborating with ten other university affiliated research centers on the project. The bill also dictates that universities and hospitals work with a drug company on the trial. The Microdose reached out to UTHealth Houston to ask which company had been selected as a partner, but a media relations representative said that the project is still in its early phases, and that “the information will be available at a later date.”

Meanwhile, Ohio’s Ibogaine Treatment Study Committee had its first meeting last week — the committee was established by Ohio’s appropriations bill, passed earlier this year. The six-person committee is tasked with researching and writing a report about ibogaine that includes recommendations for legislation, due to the general assembly by the end of 2027.

• On Thursday, President Donald Trump signed an executive order ordering the U.S. Attorney General to “take all necessary steps to complete the rulemaking process related to rescheduling marijuana to Schedule III of the CSA in the most expeditious manner.” Marijuana is currently a Schedule I drug, the most restrictive category; moving it to Schedule III would make studying it easier. Trump’s order did not specify a timeline by which to complete the process, so it could still be months or years until the drug is rescheduled.

• According to The Guardian, the number of licensed psilocybin service centers in Oregon has dropped by a third since the program launched in 2023. “The attrition is setting in, and a lot of people are not renewing their license because it is hard to make money,” the owner of a psilocybin center told the Guardian.

• In the 1960s, Harvard graduate and LSD enthusiast Lisa Bieberman shipped LSD through the USPS, started a Psychedelic Information Center in Harvard Square, and spent years advocating for psychedelics. Paul Gillis-Smith, program lead on psychedelics and spirituality at Harvard’s Center for the Study of World Religions, tells Bieberman’s story as part of a digital symposium from the Petrie-Flom Center at Harvard Law School.

• According to journalist Rachel Nuwer in the BBC there is a growing body of research that suggests “there is something specific about psychedelic substances that make them useful for supportive explorations of sexual orientation and gender identity.”

• Mark Chavez, a doctor who pled guilty to supplying the late actor Matthew Perry with ketamine, has been sentenced to eight months of home confinement, reports The Guardian. (Two weeks ago, another doctor charged in the case was sentenced to 30 months in prison.) Perry drowned in his hot tub, and an autopsy revealed high levels of ketamine in his body at his time of death.

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Federal legislators try again on psychedelics legislation

Last week, U.S. Senators Cory Booker (D) and Rand Paul (R) and Representatives Madeleine Dean (D) and Nancy Mace (R) introduced the Freedom to Heal Act, which would force the U.S. Drug Enforcement Administration to create a registration process for physicians to administer MDMA and psilocybin, a system that sounds similar to the one enacted in Australia two years ago. The press release announcing the new bill says it would give access to Schedule 1 drugs to “people with severe, life-threatening conditions, including Veterans.” Most psychedelic substances including psilocybin, LSD, DMT and MDMA are currently classified by the DEA in the most restricted Schedule 1 category.

Under the 2018 Right to Try Act, terminally ill patients can try “investigational drugs” — drugs that have undergone Phase 1 clinical trials, but have not yet been approved by the agency. But because of psychedelics’ status as Schedule I drugs patients have been unsuccessful in accessing the drugs under Right to Try laws, leading to years-long legal battles such as the case AIMS v. DEA, where palliative care physician Sunil Aggarwal sought psilocybin for his terminally ill patients. (Here at The Microdose, we’ve been covering this case for so long that it has its own tag.)

Aggarwal told The Microdose he and his team were not consulted about the newly introduced legislation. “I am happy, of course, to see it as I welcome any option that will provide complete safe harbor to patients and doctors who wish to try psilocybin therapeutically as a palliative measure, given that this option exists in several countries around the world,” he said.

This isn’t the first time Booker and Paul have tried to introduce legislation that would increase patient access to psychedelics via Right to Try laws. In 2022, they introduced the “Right to Try Clarification Act,” which would have amended the Right to Try act with a statement explicitly allowing patients to access investigational drugs even if they are Schedule I substances, but that bill never made it out of committee. In 2023, Booker and Paul first teamed up with Mace and Dean to introduce another psychedelics bill called the Breakthrough Therapies Act, which proposed updating the Controlled Substances Act to reclassify any Schedule I drugs designated by the Food and Drug Administration as potential breakthrough therapies as Schedule II drugs instead. That bill also died in committee.

Those who have been close to these failed legislative efforts struck a cautiously optimistic note about the new proposed law. Kathryn Tucker, an attorney who brought the AIMS v. DEA case, as well as a petition to the DEA to reschedule psilocybin from Schedule I to Schedule II (which, as of August, had been transmitted to U.S. Health and Human Services), noted the failure of the previous two federal Right to Try bills. But she is hopeful about this new one. “There is no reason it could not sail through,” she says, pointing out that Republicans control Congress and President Trump signed the 2018 Right to Try act into law.

New Mexico to launch psilocybin program a year early

Last Friday, New Mexico’s Medical Psilocybin Advisory Board held their first meeting. It opened with an introduction from State Senator Jeff Steinborn (D), who sponsored the legislation that created the country’s third state-regulated psilocybin program. The meeting was led by Dominick Zurlo, director of the New Mexico Department of Health’s Center for Medical Cannabis and Psilocybin, who introduced the seven-person advisory board, and the news that the Medical Psilocybin Program had hired a program manager — its first dedicated staff member — and were in the process of hiring an environmental scientist and a compliance officer.

The biggest news was that the state plans to accelerate its launch of its psilocybin program. “We have until December 2027 to get the program implemented,” said Zurlo. “Because there has been such large interest in this and a push for us to try to help people with psilocybin treatments earlier, we have set a goal now to have the program see initial patients by the end of December 2026 — a full year earlier.”

The meeting also featured public comment from attendees, including individuals speaking about their personal mental health struggles, and aspiring practitioners voicing concerns about high cost of facilitator training in Colorado and Oregon, and urging the state to build a more affordable and accessible program.

Denali Wilson, of the non-profit psychedelic advocacy organization Healing Advocacy Fund (HAF) also spoke in the public comment portion of the meeting. Wilson is HAF’s New Mexico Director of Strategic Support; her counterparts in Colorado and Oregon have played significant roles in launching and supporting those states’ programs. “While it is important for the program to move forward with urgency, achieving the right balance of safety, affordability, and equity will require careful attention and thoughtfulness - so let’s be sure that any acceleration of the regulatory timeline doesn’t unintentionally compromise patient safety, undermine long-term sustainability, or limit meaningful public engagement,” Wilson said.

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Mapping psilocybin in the brain with…rabies?

While we still don’t know what, exactly, makes psychedelics effective in treating depression or anxiety, researchers do have theories. One of them is that a drug trip interrupts cycles of negative rumination. Some researchers have gone as far as to use the phrase “rewire the brain.” A new study published in Cell tried to illustrate how psilocybin might rewire brain connections with an unconventional method: they injected psilocybin into the frontal cortex of mice’s brains, and then injected a dose of rabies.

We know rabies as an incredibly contagious and fatal disease. That’s because the rabies virus is highly adept at infecting a host’s cells and then spreading via its connections to other cells. Neuroscientists have developed methods that harness rabies’ power as a way to map the brain and track neuronal changes.The researchers in this study used those methods to map differences between mouse brains that had received psilocybin, and those that did not.

Compared with mice injected only with rabies, mice injected with psilocybin and rabies showed weaker connections between the retrosplenial cortex, visual cortex, and default mode network with frontal cortex neurons. A Cornell press release about the study framed this as evidence that “psilocybin weakens the cortico-cortical feedback loops that can lock people into negative thinking.” While some previous studies suggest that cortical and subcortical connections underlie rumination and negative feedback loops in the human brain, it’s unclear whether these weaker connections in mice are a direct analog for rumination.

They also found that mice injected with psilocybin showed stronger connections between the mouse analog of the default mode network, visual cortex, and sensorimotor network, which the researchers said in the press release could be a sign that psilocybin strengthens the link between perception and action. Again, mice are not people, and it is not yet clear how, and if, these mouse brain areas and their connections map onto human brains, but the researchers say that this is an “exciting avenue for future research” to better understand how psychedelics influence brain plasticity.

Are the “MDMA blues” real?

Among recreational MDMA users, it’s a common belief that ecstasy’s comedown includes a period of lowered mood. To find out more about this phenomenon, researchers in the UK and the Netherlands surveyed around 250 young adults who had used MDMA recreationally, and they published their results in the journal Drug and Alcohol Dependence.

The study used data from a longitudinal European study called the ALAMA Nightlife study, which collected data on not just MDMA but any recreational substance use.

For 35 days after people used MDMA, researchers asked them to fill out an app-based, daily 3-minute questionnaire about their mental well-being. It included questions such as ranking their mood, reporting substance use, sleep quality, and cognitive and social functioning.

Overall, the researchers found that participants’ reported decreased mental well-being in the three days following MDMA use. They concluded that at least part of that decrease was attributable to MDMA use, but other factors, such as sleep quality post-drug use, pre-existing depression and anxiety symptoms, and cocaine use were also associated with worse well-being ratings, though none of those factors were associated with as strong an effect as MDMA use. But, they point out, factors like sleep quality could be directly associated with MDMA use as well; the dehydration and stimulation caused by the drug could lead to worse sleep.

The mood dip post-MDMA use is sometimes called the “Tuesday blues,” based on the belief that these blues hit three days after Saturday night MDMA use. But the researchers conclude that the decrease in well-being could actually carry through the entire three days after taking MDMA.

Newly launched Center for Psychedelic Policy

On Wednesday, a new non-profit think tank called the Center for Psychedelic Policy announced its launch. Its founder and executive director is Sam Chapman, previously campaign manager for Oregon’s Measure 109 (the ballot initiative that launched the state’s psilocybin program) and former executive director of the non-profit Healing Advocacy Fund.

In an email announcing the new center, Chapman enumerated the advances in state-by-state psychedelic policy over the last five years, including the launch of Oregon and Colorado’s psilocybin programs (and the impending launch of New Mexico’s), and hundreds of psychedelic-related bills across the majority of U.S. states. “But with this momentum comes a reality we cannot ignore,” he writes. “Now we must solve the challenge that will determine whether these programs truly serve the people who need them most: affordability.”

Chapman says the center’s goal is to expand access to psilocybin, and it will focus on translating lessons from Oregon into “actionable guidance for states”, with an emphasis on affordability.

• Portland alt-weekly Willamette Week reports that the psilocybin service center The Sacred Mushroom is shuttering as a psilocybin company and its parent company will instead be pivoting to cryptocurrency.

• For the MIT Press Reader, cultural anthropologist Graham St John tells the story of how Terence McKenna became a champion for entheogens like DMT.

• The playwright Jeremy O. Harris was released after being imprisoned for three weeks in Japan for MDMA possession. According to The Guardian, “Harris was detained at Naha airport on 16 November when customs officers allegedly found 0.78 grams (0.028 ounces) of a substance containing the stimulant MDMA.” For reference, a typical dose of MDMA is between 80 to 120mg. Assuming those 0.78 grams were pure MDMA, that would be equivalent to between 6 and 10 doses.

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Federal government announces new funding for psychedelics

An agency within the U.S. The Department of Health and Human Services recently announced a $100 million investment in behavioral and mental health research with a specific call for proposals to fund research on “neuroplastogens” such as ketamine, ibogaine, psilocybin, LSD, and DMT. The funding is available through the Advanced Research Projects Agency for Health, or ARPA-H.

ARPA-H was proposed by former President Joe Biden in 2021 and funded by Congress in 2022. The program is modeled on DARPA (the Defense Advanced Research Projects Agency). The goal of ARPA-H is to usher in scientific research breakthroughs supported by substantial federal funds. The new $100 million initiative is called EVIDENT — an acronym for “Evidence-Based Validation & Innovation for Rapid Therapeutics in Behavioral Health” — which will target the development of new drugs and therapies focused on personalized mental and behavioral health treatments. The EVIDENT initiative is soliciting pitches through December 22. Applicants’ studies will need to produce results quickly: the call for pitches says projects must “deliver and demonstrate preliminary results” by the one-year mark; grants are expected to be for $4 million to fund projects for a maximum of two years.

The State of Psychedelics: New beginnings in New Mexico, New Jersey advances bill

Today, New Mexico’s Medical Psilocybin Advisory Board will hold its first public meeting. In March, the state’s legislature passed a bill establishing a state-regulated medical psilocybin program, making it the third state in the nation to create such a program. It was the first state program in the United States that was passed via the legislature rather than a voter approved ballot measure, as well as the first establishing the medical use of psilocybin. Both Colorado and Oregon’s programs explicitly prohibit facilitators from requiring that clients receive referrals from medical professionals. Advertising psilocybin services as treatments for medical conditions is also forbidden in those states. The meeting will include introductions to key staff and board members working with the state to launch its program, as well as comments from the general public.

Last week, New Jersey legislators referred Bill A3852 to the State Assembly’s appropriations committee. The bill would give $6 million to establish a two-year pilot program overseen by the state’s health department and an 11-person advisory board. If passed, the department will have 6 months to create a system to accept applications for the pilot program. The state’s legislative session ends on January 12, 2026.

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Federal government increases 2026 drug quotas for psychedelic research

Each year, the U.S. Drug Enforcement Administration sets quotas for the production of Schedule I drugs to be used in research. Proposed quotas for 2026 were posted to the Federal Register last Friday, with the agency noting increased production quotas for psilocybin, psilocin (the active metabolite of psilocybin), MDMA, and methylone (also known as MDMC, an analog of MDMA) to support clinical trials investigating their use in treating depression and PTSD.

For reference, in 2023, the DEA initially set annual quotas of 8000 grams of psilocybin; in 2026, it calls for five times that — 40,000 grams — as well as 48,000 grams of psilocin. The 2026 quotas for 5-MeO-DMT and DMT are also higher than last year. In 2025, the government allowed 20,000 grams of DMT and 11,000 grams of 5-MeO-DMT. But for 2026, the DEA is now calling for 30,000 grams of 5-MeO-DMT and 20,000 grams of DMT.

New paper argues scientists should probe psychedelics’ bond with neuroreceptors beyond serotonin

Classic psychedelics like psilocybin and LSD are often called “serotonergic” drugs based on their binding to serotonin 5-HT receptors. But “not all psychedelics are created equal,” argues a new commentary piece published in Nature Mental Health. Different psychedelic molecules have different binding affinities to a broad array of receptors in the brain. The authors, psychology and psychiatry researchers at Maastricht University in the Netherlands and the University of Lübeck in Germany, point out that 5-HT receptors are unlikely to fully explain psychedelics’ effects — when activation of the receptor has been blocked in rodent studies, psychedelics have still induced antidepressant-like effects and neuroplasticity.

It’s still unclear how psychedelics’ receptor binding affects people’s subjective experiences, and the authors propose developing more rigorous methods to assess those subjective experiences, as well as to develop more standardization in dose equivalence between psychedelic drugs, and more robust neuroimaging maps to understand how psychedelics affect brain connectivity. “Psychedelic science is not ‘one size fits all’, and its successful implementation in neuropsychiatry will probably depend on embracing the pharmacological diversity of these compounds,” they write.

Longevity influencer livestreams shrooms trip

On Sunday, longevity influencer Bryan Johnson livestreamed his experience after taking a 5-gram dose of dried Psilocybe cubensis. This is the second time in a month Johnson has publicly documented his psychedelics use; about a month ago, Johnson livetweeted his trip, which he called “longevity therapy.”

The livestream included appearances from guests including the electronic artist Grimes, who performed a DJ set, Elon Musk biographer Ashlee Vance, YouTuber MrBeast, and psychedelic venture capitalist Genevieve Jurvetson, who with her husband Steve have donated to a broad range of psychedelic initiatives, including the Fireside Project, MAPS, and the Healing Advocacy Fund.

Over the last few years, Johnson has gained notoriety for his meticulous documentation of his health regimens and the millions of dollars he’s spent tracking biomarkers looking for evidence that he’s slowing his own aging. Those attempts have included everything from a strict diet and exercise regimen to receiving blood plasma from his then 17-year-old son. Publications including Stereogum, Business Insider, and TechCrunch covered Johnson’s psilocybin stunt, which he called “research,” but it’s worth noting that Johnson is no newcomer when it comes to psychedelics research: He is the founder of Kernel, a company that created a neuroimaging helmet Johnson wore during his trip — and which, back in 2021, announced a partnership with psilocybin company Cybin to study brain function in people taking ketamine, which we reported on in our second-ever issue of This Week in Psychedelics.

• Former Arizona Senator Kyrsten Sinema is a relatively new but vocal advocate for ibogaine, but until recently, she has been close-lipped about any personal experience with the drug — but she tells Politico she tried ibogaine at a Mexico center in hopes it would help keep her brain sharp.

• Natural History Museum of Utah Ph.D. student Colin Domnauer writes about the prevalence and history of Lanmaoa asiatica, a species of mushroom believed to cause what’s called lilliputian hallucinations: “the perception of numerous little people autonomously moving about and interacting in the real-world environment.”

• The Fireside Project, a psychedelic peer support non-profit, announced the launch of Lucy, “the world’s first AI-powered simulation and training platform designed to prepare clinicians for psychedelic-assisted therapy.” Lucy was built on anonymized support conversations from 7,000 Fireside Project users.

• Salvador Plasencia, a doctor who pled guilty to supplying the actor Matthew Perry with ketamine before his 2023 death, was sentenced to 30 months in prison, reports the New York Times. Perry drowned in his hot tub, and an autopsy revealed high levels of ketamine in his body at his time of death.

• National Geographic reviews the growing numbers of clinical trials studying the use of LSD in treating anxiety, depression, and more.

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Pilot who attempted to cut plane engines after shrooms trip avoids prison time

On Monday, a U.S. District Judge in Portland, Oregon ruled that former Alaska Airlines pilot Joseph Emerson would not face prison time for a 2023 incident in which he attempted to shut down the engines of a Horizon Air flight from Everett, Washington to San Francisco. He had pled guilty to a federal count of interfering with a flight crew; he had also pled no contest to 83 counts of endangering another person (one for every other person aboard the flight), as well as one count of endangering an aircraft that had been brought against him by Oregon prosecutors.

Emerson told investigators that at the time of the incident, he had not slept in 48 hours. He had traveled to Washington to memorialize the death of his best friend and had tried psilocybin mushrooms for the first time. He described his experience aboard the flight as “dreamlike:” he said he tried to shut down the engines to get out of the dream. After the incident, some commentators in news stories cast doubt about psilocybin having anything to do with Emerson’s actions, saying that mushroom trips typically only last 6 to 8 hours and that the substance would have cleared his system by the time he got on that plane two days after ingesting psilocybin. “I felt that the psychedelic movement was, in effect, trying to throw him under the bus by insisting that magic mushrooms couldn’t have affected him 48 hours after he took them,” writes Jules Evans, founder of the Challenging Psychedelic Experiences Project, who earlier this week published an extensive interview with Emerson in his newsletter, Ecstatic Integration.

In the interview, Emerson told Evans that before taking mushrooms he’d seen the Netflix documentary “Have a Good Trip,” and had no idea that psilocybin could produce such prolonged difficulties. “If I knew the risks, there’s no way I’d take that substance,” he said. He goes on to describe his trip, where he felt increasingly paranoid and anxious that something was amiss. He says he did not return to “a full sense of reality” until he was being arraigned for attempted murder.

Emerson was sentenced this week to time served and three years of supervised release. In Oregon, he was previously sentenced to time served and five years probation, as well as over 600 hours of community service, which he can serve in part by working on a new non-profit organization Emerson and his wife founded called Clear Skies Ahead. The organization supports mental health and wellness for pilots, air traffic controllers, and their families.

LSD microdoses not more effective than placebo in treating depression

Results from a Phase 2B clinical trial from Melbourne-based psychedelic company MindBio Therapeutics suggest that LSD microdoses are not more effective than placebo at treating major depressive disorder. The results have not yet been published in an academic journal, but CEO Justin Hanka published topline results on LinkedIn. In the study, 89 patients were given either LSD microdoses or placebo (caffeine) pills to take at home twice a week for eight weeks. Their depression symptoms were measured using the MADRS, a standard depression rating scale, at the beginning of the study and after eight weeks. Both groups showed a reduction in symptoms, but there was no significant difference between the placebo group and the LSD microdosing group.

The results are “not what we expected or hoped for,” Hanka wrote in his LinkedIn post. But the company claims they have found that participants’ speech changes when taking an LSD microdose, and that they have developed a “proprietary predictive algorithm” that can, they claim, detect whether someone has taken the drug. Hanka’s LinkedIn post did not include any further details to substantiate these claims, but Hanka did write that the company is also developing a tool to detect alcohol intoxication for use in law enforcement and suicide prevention.

Results from MindBio’s Phase 2A trial appeared in a special issue of Neuropharmacology focused on microdosing. (We included results from another study from that issue two weeks ago, which found no differences between psilocybin microdoses and placebo for mood and cognition.) Unlike the 2B study, the 2A clinical trial was open-label, meaning all participants knew that they were receiving an active drug. In the 2A study, participants saw an average reduction of 59.5% in MADRS scores; in the 2B study, those reductions were 36.4% in the placebo group and just under 30% in the LSD microdose group. In previous psychedelic studies, researchers have theorized that even the suggestion that participants could receive a placebo might decrease overall drug efficacy in clinical trials, and this could explain the large differences between efficacy in the 2A and 2B trials.

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Psychedelics advocate Calley Means now an advisor to RFK Jr.

The New York Times reports that Calley Means is now officially serving as a senior advisor to Health and Human Services Secretary Robert F. Kennedy, Jr. Means has been a vocal advocate for psychedelics, writing about them on his blog and lauding MAPS founder Rick Doblin as a hero.

President Trump nominated Means’s sister Casey Means as U.S. Surgeon General, but she went into labor with her first child shortly before her Senate confirmation hearing in October and has yet to be confirmed. Casey, too, has publicly advocated for psychedelic access. In Good Energy, a 2024 book she co-wrote with her brother Calley, she described her experiences with psilocybin-assisted therapy. Upon Casey’s nomination as Surgeon General, some right-wing figures, including Laura Loomer, criticized her psychedelic use.

Reports from people mixing antidepressants and classic psychedelics

Antidepressants like Prozac act on the body’s serotonergic system, as do psychedelics such as psilocybin and LSD. To avoid potential interaction effects between antidepressants and psychedelics, which can include serotonin toxicity, some clinical trials as well as many underground practitioners advise that people go off antidepressants before taking psychedelics. In online forums, it’s common to see people advising others that SSRIs can dampen a trip, and suggesting that SSRI users try a higher psychedelic dose to compensate for that potential dampening effect.

A new study published in the recently launched academic journal Psychedelics analyzed reports from 40 people who had mixed psychedelics and antidepressants that act on the body’s serotonergic system, and wrote about their experience on the drug education website and community forum Erowid. Of those reports from people taking SSRIs, 20 people used psilocybin, 14 LSD, and six used both psilocybin and LSD. The majority — 26 people, or 65% of participants — reported having less intense trips, a common experience for SSRI users. But six people felt SSRIs did not affect their trip, and another five said they felt it enhanced the trip. While many reported weak visual or other sensory effects, nine included elements indicating a mystical-type experience, which the authors define as “profound alterations in consciousness, including experiences of unity, transcendence of space and time, and noesis.” The preservation of these mystical experience elements could be the reason people on SSRIs in previous clinical trials still experience therapeutic effects of psychedelics, the authors write.

In terms of safety, the authors report that two people who had taken LSD reported symptoms that could indicate serotonin toxicity, like body temperature dysregulation or struggling to breathe — but those symptoms could also just indicate a difficult trip. “Our exploratory findings challenge widespread beliefs that combining serotonergic antidepressants with classical psychedelics poses inherent safety risks,” the authors write. But Erowid reports are hardly a general sample, they note, and they call for more robust, controlled studies investigating interactions between psychedelics and SSRIs.

• An ultrarunner is filming a documentary detailing his LSD- and psilocybin-fueled 500-mile run from Manitou Springs to Moab, the Colorado Sun reports.

• Author Abbie Rosner writes about the details of a new clinical trial studying psychedelics in older adults, funded by the National Institute on Aging and National Center for Complementary and Integrative Health, both a part of the National Institutes of Health.

• Political reporter Olivia Nuzzi’s new book has made quite the splash in the journalism world for its flowery prose and dishy gossip. According to The New York Times, Nuzzi, who had a romantic entanglement with Robert F. Kennedy Jr. while he was on the presidential campaign trail, stated that the Health Secretary still takes psychedelics, including DMT, despite being sober for decades.

• Three weeks ago, Jamaica was hit hard by Hurricane Melissa, and recovery will likely take years. DoubleBlind talked to leaders in its burgeoning psychedelics industry, who fear that wealthy developers will buy up land that once belonged to Indigenous and rural people.

• MAPS and Ohio State’s Center for Psychedelic Drug Research and Education announced that they will be partnering to train more than 127,000 Ohio doctors, nurses, social workers, EMTs, police officers, and other professionals in psychedelic harm reduction and crisis response. The Ohio Department of Behavioral Health is providing $400,000 in funding for the program.

• Attention journalists: applications are now open for $10,000 awards to report in-depth print and audio stories on psychedelics. The Ferriss – UC Berkeley Psychedelic Journalism Fellowship application is due on January 31, 2026.

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Happy Friday and welcome back to The Microdose, an independent journalism newsletter brought to you by the U.C. Berkeley Center for the Science of Psychedelics.

Closed-door MAHA summit discusses psychedelics

On Wednesday, Secretary of Health and Human Services Robert F. Kennedy Jr. and his “Make America Healthy Again” allies held a day-long summit at the Waldorf Astoria hotel in Washington DC. The speaker list included a who’s who of government officials including Vice President JD Vance and Food and Drug Administration commissioner Marty Makary. The summit also included industry leaders and medical technology, or “medtech” influencers such as longevity entrepreneur Bryan Johnson, who, earlier this week, livetweeted his trip after taking nearly five grams of dried Psilocybe cubensis as a “longevity therapy.”

The summit was closed to the media but speakers covered a wide variety of topics such as the future of the FDA and NIH. Psychedelics were also on the agenda at the summit in a session with Christian Angermayer, co-founder of psychedelic company atai (now AtaiBeckley) and an early funder of Compass. Angermayer was joined by Matt Zorn, an attorney who has sued the federal government over cannabis and psychedelic drug reform issues, and accepted a position as Deputy General Counsel at Health and Human Services in May. Some have called him the Trump administration’s “psychedelics czar.” The conversation was titled “Psychedelic Medicine: The Next Frontier in Mental Health.”

While little was reported from inside the summit due to the ban on media, attendees posted snippets on social media sites.

Maryland task force recommends psilocybin program

In 2024, the Maryland legislature passed a bill establishing a 19-person task force to study “natural psychedelic substances,” including psilocybin, DMT, and mescaline (excluding peyote). Recently, that task force released their findings in a detailed 373-page report, along with a set of recommendations.

Ultimately, the group recommended starting with psilocybin, and gradually rolling out psychedelic reforms in three stages. First, establish regulatory infrastructure like advisory boards, facilitator training, law enforcement training, and testing labs for a psilocybin program. Next, launch a program that includes medical oversight of psilocybin use before potentially allowing commercial sales, and expansion to other psychedelics.

The task force’s goals, they write, are to “ensure responsible and gradual expansion of access while maintaining capacity to identify and respond to emerging issues swiftly” — and part of that, it seems, is not waiting for federal agencies to take the lead. The group “does not support delaying state action pending future federal FDA approval,” the report states, in bold.

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New Oregon psilocybin rules, including psilocin reporting

Last Thursday, Oregon Psilocybin Services announced they had adopted amendments to the Oregon Psilocybin Services Act, which will go into effect January 1, 2026. Many of these changes are clearly a response to issues facilitators and clients have noted along the way. The new rules represent efforts to make the nation’s first state-regulated psilocybin program safer and more equitable.

Some of the rules were mandated through the passage of House Bill 2387, also known as the Oregon Psilocybin Services Program Improvement Bill, earlier this year. The bill shields health professionals who facilitate psilocybin sessions from disciplinary action by state professional regulatory boards such as the Oregon Medical Board, and requires that all psilocybin products be labeled with their psilocin content in addition to their psilocybin content. (A quick primer on psilocin: psilocybin is the prodrug of psilocin; when a human ingests psilocybin, it’s metabolized into psilocin. Mushrooms can contain both psilocybin and psilocin so knowing the quantity of psilocybin alone is not sufficient to predict the strength of a dose.)

The newly adopted amendments also include changes mandated by Senate Bill 907, also passed earlier this year, requiring all licensed psilocybin manufacturing facilities and license applicants to submit a notarized consent form from the owner of the property they operate from acknowledging that they approve.

Other changes include allowing psilocybin facilitator trainees to transfer hours between programs, should their program shut down, and requiring service centers to include how many clients opted-out of data sharing in their quarterly reports to the state.

Synthetic 5-MeO-DMT reduces depression scores

On Monday, pharmaceutical company AtaiBeckley announced preliminary results from an open-label extension following its Phase 2b clinical trial using BPL-003, a synthetic 5-MeO-DMT nasal spray, for treatment-resistant depression. In the initial clinical trial, the results of which were released in July, nearly 200 participants received 12mg, 8mg, or 0.3mg (placebo) doses of BPL-003. Researchers took baseline measures of participants’ scores on the MADRS, a standard depression questionnaire, and again the following day, the following week, four weeks later, and eight weeks later. The company reported that participants who received the largest dose showed, on average, an 11-point lower MADRS score four weeks after receiving BPL-003, while those in the placebo group showed a 6-point reduction. (A lower MADRS score indicates fewer depression symptoms.) MADRS scores of those who received 8mg of BPL-003 were, on average, 12 points lower, similar to that of the 12mg group, suggesting that the slightly smaller dose “may be sufficient to achieve therapeutic benefit,” the company’s press release says.

The study’s extension entailed giving over 100 participants from the Phase 2b trial a 12mg dose of BPL-003 8 weeks after their initial dose, then tracking their MADRS scores the next day, and then again at one-week, one-month, and 8-week timepoints. Unlike the initial Phase 2b study, where both participants and researchers were blinded to which dose participants received, this extension was open-label: all involved knew participants were receiving a 12mg dose of BPL-003. All three groups showed lower depression scores after receiving the drug, and those effects persisted to the 8 week mark.

The results follow a flurry of recent headlines from the company - chief among them that atai and Beckley Psytech recently merged, and the U.S. Food and Drug Administration granted BPL-003 breakthrough therapy status designation. The company says it has a meeting scheduled with the FDA to discuss the design of its Phase 3 clinical trial program, which could begin as soon as the second quarter of next year.

Relationship between psychedelic use and alcohol use disorder

While clinical trials are investigating the use of psychedelics like LSD in the treatment of alcohol use disorder, anecdotes abound of people who say they lost interest in drinking after taking psychedelics. A new study published in Journal of Psychoactive Drugs examined associations between psychedelic use and alcohol use disorder using data from the National Survey on Drug Use and Health (NDSUH), an annual survey on Americans’ substance use.

The researchers analyzed NSDUH data from 2021, 2022, and 2023 and found that LSD use within the last year and lifetime mescaline and DMT use was associated with lower odds of alcohol use disorder symptoms in the previous year. While previous-year use of MDMA and ketamine showed no correlation with previous-year alcohol use disorder symptoms, lifetime use of MDMA and psilocybin were both associated with a higher likelihood of alcohol use disorder symptoms in the previous year.

Correlational studies like this one reveal only associations between variables, not causation, so it’s unclear whether psychedelic use directly affects alcohol use disorder symptoms. But, the researchers write, this work sheds light on the fact that different psychedelics present different risk profiles in relation to alcohol use disorder symptoms.

• Recently, Colorado’s Natural Medicine Advisory Board recommended the state look into adding ibogaine to its program — and to ensure the iboga they import is ethically and sustainably produced in Gabon. But The Colorado Sun reports that a board member filed an anonymous complaint last month asking regulators to investigate Ean Seeb, Colorado Governor Jared Polis’s special advisor on cannabis and psychedelics, for “putting pressure on the board” to change their minds about sourcing sustainable iboga.

• In his newsletter Ecstatic Integration, Jules Evans dives into the psychedelic coaching industry, and what accredited coaches think of the practice.

• Internal Family Systems, or IFS, is a popular therapy approach, often used in psychedelic-assisted therapy. But some patients tell The Cut that IFS has destroyed their lives.

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Could psilocybin be the first FDA-approved psychedelic?

On Tuesday, British psychedelics company Compass Pathways announced that they’ve accelerated the timeline for the commercial launch of using their formulation of synthetic psilocybin, COMP360, by 9 to 12 months.

The company released preliminary results in June indicating that COMP360 decreased depression symptoms. In a press release summarizing the company’s most recent earnings call, the company said they’d had “positive” meetings with the U.S. Food and Drug Administration in September, and that they plan to release data from COMP005, a Phase 3 trial, early next year, as well as some data from COMP006, another Phase 3 trial.

After that, Compass “may begin a rolling submission in alignment with the FDA,” the company’s CEO Kabir Nath told The Microdose. “We now expect the 26-week readout from COMP006 in early Q3 2026, and we anticipate that dataset will be the final component to complete our NDA package for COMP360 in treatment-resistant depression. We are very encouraged by FDAs support of our TRD program and excited to advance our mission to transform the mental health landscape.” Given that the FDA takes 6 to 10 months to review new drug applications, this new timeline could mean COMP360 approval sometime in 2027.

After Lykos’s new drug application for MDMA was not approved by the Food and Drug Administration last summer, industry insiders have been looking to Compass as the psychedelics company most likely to seek a new drug approval. Atai’s former CEO Florian Brand posted on X that the news is “a clear sign that the FDA remains pragmatic, flexible and forward-leaning on evidence-based innovation in mental health.” Christian Angermayer, atai’s other co-founder and an early Compass founder, called the news “one of the clearest signs that we are truly entering the age of psychedelic medicine.”

Australia to fund psychedelic-assisted therapy for veterans

Last Friday, Australia’s Department of Veterans’ Affairs announced that it would provide funding for veterans to receive MDMA-assisted therapy to treat PTSD, and psilocybin-assisted therapy for treatment-resistant depression. The country surprised psychedelic insiders in 2023 when it announced that it would begin allowing authorized psychiatrists to deliver psychedelic-assisted therapy.

According to 2021 census data, there are around 600,000 veterans in Australia. In the Department of Veterans’ Affairs announcement about their decision, the agency said that not all veterans diagnosed with PTSD or treatment-resistant depression would be eligible; rather, they will need to be assessed by providers for approval. Moreover, individuals cannot self-fund treatment, and their provider must request funds from the department for treatment.

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No differences in mood and cognition between microdosing and placebo

While many people say microdosing improves their mood, well-being, or productivity, results from two double-blind trials suggest that a placebo produces similar improvements. In a paper published recently in Neuropharmacology, participants received either microdoses of psilocybin mushrooms, or a placebo pill that contained inert cellulose or non-psychedelic mushrooms. Before beginning the study, researchers measured participants’ performance on cognitive tests and found that there were no differences between the placebo group and the microdose group after participants received their doses. There was also no significant difference in participants’ ratings of pleasure or arousal.

However, the researchers say that most participants reported feeling some kind of subjective effect, and that 48% of participants who reported symptoms were in the placebo condition. That included two participants in the placebo condition reporting “strong adverse reactions, including flashbacks, extreme insomnia, and intense emotional experiences.” Microdoses are meant to be sub-perceptual,meaning they don’t cause common psychedelic effects like hallucinations. In this study, when researchers asked participants to guess whether they received a microdose or placebo, their guesses were no better than chance.

The results suggest that expectation makes substantial contributions to the effects of microdosing, and, in the authors’ words, “contribute to the growing number of placebo-controlled studies [of microdosing] that report inconsistent findings regarding cognitive and emotional benefits.”

AtaiBeckley merger completed

On Wednesday, atai Life Sciences and Beckley Psytech announced that their merger was complete: the company is now AtaiBeckley.

The two companies first announced their merger plans in June, pending results from a Phase 2B study using BPL-003, a synthetic nasal form of 5-MeO-DMT, for treatment-resistant depression. Preliminary results from that study were released in July, and 12mg and 8mg doses of BPL-003 reduced participants’ depression scores significantly more than a 0.3mg (placebo) dose. Three weeks ago, BPL-003 received Breakthrough Therapy designation from the U.S. Food and Drug Administration.

According to the company, AtaiBeckley expects to meet with the FDA to discuss its Phase 3 trials for BPL-003 soon, and that those trials could begin in mid-2026.

Psychedelic use in the real world

Psilocybin use in the United States has “sharply increased,” according to a new review published in JAMA Psychiatry, and alongside it, psychedelics-related poison control center calls have surged as well. According to poison control center reports, people have taken a psychedelic together with another substance in approximately 30% of cases; those substances are typically either cannabis or alcohol, and 85% of those cases resulted in hospitalization.

The authors, researchers at the University of Colorado Anschutz Medical Campus, argue that more research is necessary to better understand how psychedelics interact with other drugs. Such research could also improve public health approaches to keeping people safer. The researchers also recommend potency testing to better inform consumers. Cannabis, they say, is a good comparative case study: while the potency of cannabis flower in 1995 was about 4% THC, it’s now more than 20%. Similarly, the potency of psilocybin containing mushrooms can vary widely; the researchers cite data from Oakland Hyphae, whose analyses found that some samples had more than 20-fold more psilocybin content than others.

The researchers also identify an understudied aspect of psychedelics: the effects of naturally occurring, whole psilocybin mushrooms, rather than the synthetic compounds currently being developed and studied by psychedelic pharmaceutical companies. (Last week, Phoenix NPR affiliate KJZZ reported that a study using whole psilocybin mushrooms will soon be underway in Arizona.)

“The purpose of this review is not to advocate for stricter laws or greater enforcement of psilocybin or psychedelic use outside the clinic,” the authors conclude, “but rather to underscore the urgent need for new research programs to address the public health implications of a social environment that is already promoting greater use of psilocybin and other psychedelics.”

• The FDA’s rejection of Lykos’s new drug application for MDMA is an opportunity, writes consultant Jama Pitman in an op-ed for STAT. “This moment is less a dead end than an opportunity to learn from the Lykos experience and move the field forward,” she says, suggesting that future studies employ better trial design, full safety disclosures, and long-term observation.

• Last week, the non-profit National Security Archive, based on the George Washington University campus, published newly declassified transcripts from closed-door 1975 hearings in which Sidney Gottlieb, who worked on the government’s MK-ULTRA mind control experiments, testified about the government’s disturbing LSD research projects.

• This week, the Psychedelic Access and Research European Alliance (PAREA) sent a letter to Ursula von der Leyen, President of the European Commission, calling on the commission to launch a “mental health moonshot” that would support research into novel therapies like psychedelics.

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