A flurry of new state bills; Preliminary synthetic 5-MeO-DMT phase II results; Lessons from a suicide
Plus: Evaluating Oregon’s psilocybin services workforce
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.
A flurry of new bills, and advocates oppose new psilocybin services legislation in Washington State
The psychedelics-related legislation season is in full swing nationally. On Monday, the Virginia Senate voted unanimously to pass Senate Bill 1101, which creates a Breakthrough Therapies for Veteran Suicide Prevention Advisory Council. If approved, council appointees would “provide assistance to and advise the Department of Health on methods to support clinical research and implementation of treatment of post-traumatic stress disorder, treatment-resistant depression, major depressive disorder, and traumatic brain injury.” It now heads to the House for a vote.
Last week, lawmakers in New Mexico proposed Senate Bill 219, or the Medical Psilocybin Act, which would make it state-legal for clinicians, producers, or patients to grow, prescribe, or use psilocybin for medical purposes, and establishes a state department and advisory board to create a state medical psilocybin program. That program would receive $2 million from the state’s Department of Health’s general funds to start the program.
A New Hampshire representative introduced House Bill 528-FN, which would allow people over 21 to “obtain, purchase, transport, possess, or use psilocybin” starting in 2026. Unlike some similar bills previously introduced in other states, this bill does not specifically state an upper limit to the amount of psilocybin people can have and use.
Last month, we reported that legislators in both Colorado and Virginia filed bills to make it state-legal to use or prescribe “crystalline polymorph psilocybin,” or COMP360, a proprietary formulation of psilocybin produced and patented by psychedelics company Compass Pathways. Kansas legislators have now also introduced a “crystalline polymorph psilocybin” bill; House Bill 2218 would exclude the drug from the state’s definition of “psilocybin,” and would instead classify it in the state’s controlled substances act as a schedule IV drug. According to the text of the bill, it was “requested by Steve Kearney on behalf of Compass Pathways” — Kearney is the founder of a communications firm. Just how these bills are proliferating and why legislators are choosing to move them forward is unclear. The Microdose has reached out to state legislators and to Compass Pathways twice for comment but has thus far not received a response.
Last month, we reported that Washington Senator Jesse Salomon (D) proposed Senate Bill 5201, which would create a state-regulated psychedelic services program similar to those in Oregon and Colorado, which would begin in 2027. (Its companion bill in the house is HB 1433.) This week, the House Health Care & Wellness and Senate Health and Long-Term Care committees held public hearings on the proposed legislation.
In the days before the hearing, Washington psychedelics advocates and activists organized to oppose the bill’s current language, and instead to encourage the legislature to amend the bill to protect Washingtonians’ right to personal use of psilocybin outside of regulated settings.
“Although the bill would legalize access to psychedelic experiences in strictly regulated settings, advocates oppose the bill because they say it would create an oligopoly on psychedelic experiences that criminalizes people who seek the experiences outside of clinical settings,” advocacy group REACH Washington Coalition wrote in a press release. According to the statement, costs in Oregon are prohibitively high — typically upwards of $1000 for a single session — despite the fact that “psilocybin can be found in nature or grown at nominal cost.”
Representative Nicole Macri (D) proposed an amended version of the bill, which specifies that the bill “does not preclude or supersede local ordinances” — an explicit acknowledgment of the four Washington cities that have previously voted to make prosecution of psilocybin-related laws the lowest enforcement priority. But the amendments do not resolve REACH WA’s concerns, says Jon Dennis, an attorney and an advisor to the group. The proposed bill still explicitly allows law enforcement to apprehend people who violate the psilocybin program’s rules and requires enforcement to notify prosecutors, and also makes unlicensed facilitation a gross misdemeanor and any subsequent violations a Class C felony. “There is no statutory clarity concerning the scope of practice, meaning that it may result in the criminalization of harm reduction services at festivals and gatherings, and religious use,” Dennis told The Microdose.
At their Thursday meeting, the Senate Health and Long-Term Care Committee also discussed another psychedelics bill co-sponsored by Senator Salomon: SB 5204, which would direct the University of Washington to conduct a study to determine the efficacy of ibogaine-assisted therapy in treating opioid use disorder. At the meeting, Salomon said this study would be undertaken by UW researcher Nathan Sackett, who directs the Center for Novel Therapeutics in Addiction Psychiatry.
Preliminary synthetic 5-MeO-DMT phase 2 results
The hallucinogenic compound 5-MeO-DMT comes from the secretions of Bufo alvarius, also known as the Sonoran Desert toad. This week, two companies developing synthetic forms of the substance as medical treatments announced preliminary results.
UK-based biotech company Beckley Psytech publicized initial findings from a phase IIa study of BPL-003, a synthetic nasal form of 5-MeO-DMT, in treating alcohol use disorder alongside cognitive behavioral therapy. (Beckley completed its phase I study of BPL-003 in late 2022, and reported that no serious adverse events resulted from its use.)
The study included 12 people with moderate to severe alcohol use disorder, and was open-label, which means all participants knew they were receiving BPL-003 rather than a placebo. Beckley Psytech reported that the average amount of alcohol consumed by participants dropped after participants received a single dose of BPL-003 and therapy, and that half the participants had abstained from drinking in the 12 week follow-up period after their dosing session.
Dublin-based biopharma company GH Research also announced positive preliminary results for GH001, a synthetic inhalable form of 5-MeO-DMT, in a phase IIb study in people with treatment-resistant depression. The study included 81 people, 40 of whom received GH001 and 41 who received a placebo. Unlike Beckley’s study, participants did not receive therapy alongside their dosing session. Overall, GH reported that participants who received GH001 showed a significant reduction in their depression symptoms a week after their dosing session, while participants in the placebo session showed a slight uptick in depression symptoms.
Neither company’s data has yet to be peer-reviewed, but after GH Research announced its results, the company’s stock value jumped from $11.75 to nearly $20 a share. (Beckley Psytech is a privately held company.)
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Lessons from suicide
Researchers in Switzerland submitted a case report to the journal Psychiatry Research detailing the 2023 suicide of a patient after receiving psilocybin-assisted therapy. The patient had a two-decade history of depression, and over the years, he’d tried a variety of treatments, including psychotherapy and several antidepressants. He was admitted to University Hospital Basel in March 2023 reporting feelings of hopelessness, exhaustion, and brain fog, and received inpatient treatment at the hospital for over 7 months, which included lithium, ketamine, and transcranial magnetic stimulation, but nothing worked. “Treatments with psilocybin and other psychedelic drugs can be granted by Swiss authorities in specific cases,” the authors write, and so this patient received psilocybin-assisted therapy. The treatment followed an Acceptance and Commitment Therapy (ACT) approach with a total of four psilocybin sessions. Three days after the fourth session, the patient died by suicide.
The authors acknowledge that suicide after psychedelic-assisted therapy is rare, and that there were many preexisting suicide risk factors present, including existential fears, interpersonal conflicts, and, as the authors put it, “male gender” (the global suicide rate for men is over twice that for women). But they note that this case “underscores critical considerations for psychedelic-assisted therapy,” such as the importance of following up with patients after treatment, which could in some cases best be accomplished through inpatient care. The patient also appeared to withhold some of his inner thoughts and potentially delusions or psychotic symptoms from his treatment team, which underscores the importance of establishing a strong therapeutic alliance between patient and clinicians before beginning psychedelic-assisted therapy.
Evaluating Oregon’s psilocybin services workforce
Oregon’s psilocybin services program was the first legal psychedelics industry in the U.S. In late 2023, a group of researchers in the state set out to collect data about the industry’s workforce. Their findings, published in Journal of Psychoactive Drugs, “may inform policy decisions, improve training programs, and lay the groundwork for future research on service delivery and outcomes,” the authors write.
Overall, they found that the tuition costs for psychedelic facilitator training programs ranged widely, from $4,500 to $12,000, and “ranged in intensity from 80 to 200 hours of coursework, plus a practicum experience.” Of the 106 participants who responded to the researchers’ survey, the majority (57%) had a professional license or certification in healthcare, and 90% said they intended to work in a licensed service center, though the authors note that 9% of respondents stated that they preferred not to answer the question. The vast majority — 93% — said they wanted continuing education options, and that they wished they’d had more in-person training, scholarship opportunities, and more diversity among trainees in facilitator training programs.
The authors note that if the survey’s demographics — 64% were white, and 40% identified as a sexual or gender minority — are representative of the psilocybin workforce, “it appears that early efforts to train psilocybin facilitators may have achieved a somewhat more diverse workforce relative to the Oregon population,” they write. A theme that emerged in their surveys was facilitators’ desire to use expertise from their professional fields, including therapy, medicine, nursing, and social work, in their psilocybin facilitation work. (Oregon legislators are currently considering House Bill 2387, which would, among other things, protect medical and health professionals from being disciplined by the state’s professional regulatory boards if they also do work as psilocybin facilitators.) Many of the respondents work part-time as contractors at service centers. In the survey, many reported wanting more access to insurance and banking services that worked with their psilocybin facilitation businesses. Like cannabis, psilocybin remains illegal at the federal level and financial institutions often won’t bank with or offer loans to such businesses to minimize exposure to potential legal trouble. “Facilitators may pass on the cost of expensive, specialized liability insurance to clients,” the authors write. “Indirectly, this could result in service inequities for lower-income clients.”
CBS show 60 Minutes followed nine veterans to Mexico for a psilocybin and 5-MeO-DMT retreat to treat their PTSD.
Shereef Elnahal, who was appointed by former President Joe Biden as the Under Secretary for Health at the U.S. Department of Veterans Affairs, pushed for the VA to be a leader in MDMA-assisted therapy research. Recently, he announced his resignation, and on Tuesday, the U.S. Senate confirmed former Air Force chaplain and Georgia Congressman Doug Collins as the VA’s new secretary; the new under secretary to replace Elnahal has not yet been appointed.
“The psychedelic movement has built new frontiers around Elon Musk, Maga, QAnon, fans of Jordan Peterson and the broader anti-woke network around Joe Rogan,” writes Ed Prideaux in a New Statesman piece about the “psychedelic elite.”
Business Insider covers the growing trend of white-collar parents who use psychedelics including MDMA, LSD, and psilocybin or other drugs to unwind.
In his new memoir Source Code, Bill Gates writes about dropping acid in high school with his friend and later Microsoft co-founder Paul Allen, according to People.
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