New analysis: Psychedelics may be no better than SSRIs in treating depression, Kentucky ibogaine bill and New Mexico psilocybin equity fund
Plus: Bretisilocin becomes first psychedelic to receive EU priority medicines, Psychedelic Medicine Association's accreditation program and Oregon palliative psilocybin lawsuit inching forward
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.
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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