VA funds first psychedelics study since the 1960s; Colorado municipalities pass ordinances to restrict psilocybin businesses; What would Trump’s cabinet nominees mean for psychedelics?
Plus: Permanent psilocybin bans in Oregon, and should people with schizophrenia be excluded from psychedelics studies?
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.
VA funds its first psychedelics study since the 1960s
This week, the U.S. Department of Veterans Affairs announced it is spending $1.5 million on a new study using MDMA-assisted therapy to treat veterans with both PTSD and alcohol use disorder. The research is the first VA-funded psychedelics study since the 1960s. VA researchers affiliated with Brown University and Yale University will carry out the research at VA hospitals in Connecticut and Rhode Island. In psychotherapy sessions, participants will receive a full dose of MDMA or an active placebo, which will be a lower dose of MDMA.
Colorado municipalities pass ordinances to restrict psilocybin businesses
Last week, the Colorado Springs City Council voted 6-3 to pass an ordinance preventing psilocybin centers from operating within a mile of child care centers, daycares, or schools, as well as drug or alcohol treatment centers. The ordinance was proposed last month, as the state prepares to start issuing licenses for its Natural Medicine Program, which will allow people to receive psilocybin at what the program calls “healing centers.” Measure 122, the ballot initiative that established the program, does not allow municipalities to opt out of providing services. It does still allow municipalities to issue “reasonable” restrictions dictating where and when such businesses can and cannot operate, and some places, such as Colorado Springs are proposing restrictions ahead of the Colorado program’s launch at the end of the calendar year.
The day before it voted, the council held a work session where it heard perspectives from invited speakers. Richard Zane, the executive director of emergency services at University of Colorado Health, said psilocybin had promise as a treatment but that the science on its negative effects is still developing. “I find it to be a very risky proposition, in all candor – but with enormous positive potential,” he said of the state’s new psilocybin program. “I wouldn’t want it near a library; I wouldn’t want it near children, near an elementary school,” he said. Other speakers included Tania Poinsatte, Colorado director of psychedelic advocacy non-profit Healing Advocacy Fund, and Henny Lasley, co-founder of One Chance to Grow Up, a group founded to “protect kids from THC.” The council also heard from members of the public before they voted, many of whom said the ordinance was essentially a ban on psilocybin within city limits.
As we reported last month, the city of Fountain, Colorado is considering a similar ordinance, which would additionally require centers to operate only between 9am to 5pm.
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What would Trump’s cabinet nominees mean for psychedelics?
As president-elect Donald Trump announced his cabinet nominees, many are trying to parse how those picks might affect the future of all kinds of things, including access to psychedelic substances. So far, Trump’s nominees include Robert F. Kennedy Jr. to run Health and Human Services, surgeon Martin Makary to run the Food and Drug Administration, Mehmet Oz to run the Centers for Medicare and Medicaid Services, and Jay Bhattacharya to run the National Institutes of Health. (Trump had also tapped Florida’s Hillsborough County sheriff Chad Chronister to run the Drug Enforcement Administration, but Chronister backed out three days later.)
Kennedy has previously stated his intention to advocate for psychedelics, and he’s spoken publicly about his son’s positive experience with ayahuasca. However, it’s unclear what he might do as head of HHS. “You don’t want to tangle psychedelics up with the kind of science that RFK Jr. has been promoting,” author Michael Pollan recently told Politico, referring to such things as his support hydroxychloroquine as a COVID-19 treatment and his anti-vaccination claims. “My worry is that his embrace will make psychedelics seem kooky…If the science is as good as the promoters think it is, then it will be approved under its own steam, without forcing it down the throat of the FDA.” Meanwhile, on social media sites like Reddit and Twitter, users have been speculating about nominees’ views on psychedelics.
Here’s what we know so far.
FDA commissioner nominee Makary was a harsh critic of the FDA during the Biden administration, specifically criticizing the agency’s decision to pause the use of Johnson & Johnson’s COVID-19 vaccine amid safety concerns. In Trump’s announcement about the nomination, he promised Makary would “course-correct and refocus” the FDA. “FDA has lost trust of Americans, and has lost sight of its primary goal as a regulator,” Trump wrote. So far, we could find no evidence that Makary has spoken publicly on psychedelics. If Trump’s nominees are confirmed, Makary would report to Kennedy.
NIH director nominee Jay Bhattacharya has also not spoken in direct support of psychedelics. However, in March, he posted on X about an episode of his podcast, The Illusion of Consensus, in which his co-host Rav Arora interviewed Canadian physician Pamela Kryskow about using psychedelic-assisted therapy as a treatment for depression. “This is a topic I do not know well and I learned much from listening,” he wrote. If confirmed, Bhattacharya would have power over setting NIH policy and advising the president on the agency’s annual budget requests.
Some have posited that Trump’s pick for Deputy HHS secretary Jim O’Neill might be pro-psychedelics; O’Neill was CEO of Peter Thiel’s private foundation between 2009 and 2012. (Thiel, the founder of PayPal, is a major investor in psychedelics companies atai Life Sciences and COMPASS Pathways; he is one of several high-profile tech billionaires who are enthusiastic about psychedelics. He was also a mentor to Vice President-elect J.D. Vance.) O’Neill has also been critical of the FDA, calling for the agency to pare down its approval processes, so that drugs are assessed only for safety and not efficacy. In a 2014 speech, he said people should be allowed to use drugs “at their own risk.” O’Neill was previously a speechwriter at HHS in the early 2000s.
Physician and TV personality Mehmet Oz, nominated to lead the Centers for Medicare and Medicaid Services, has been a long-time advocate for cannabis reform, and in 2019, he appeared on Jimmy Kimmel Live advocating for more research into how psychedelics could be used to treat substance use disorders.
The Latest in Oregon: Permanent psilocybin bans and updated program rules
Over the last week, Oregon counties filed their official results for the November election. In that election, seventeen municipalities voted on ballot measures to prohibit psilocybin services.
The reason for these local ballot measures goes back to the 2020 election, when Oregon voters passed Measure 109, a state-wide ballot initiative that created Oregon’s psilocybin program. The measure allowed municipalities to opt out of having psilocybin services, and in November 2022, as the state prepared to roll out its program, voters in 27 Oregon counties and dozens of cities voted to prohibit psilocybin services. While some of those municipalities banned psilocybin outright, others passed temporary, two-year bans; as those bans expired, those 17 municipalities again asked voters to weigh in on psilocybin services.
The final results led to permanent bans in unincorporated areas of Clackamas County, and in 15 towns across several Oregon counties. The city of Redmond was the only municipality who proposed a measure to extend its existing two-year ban for another two years rather than permanently banning psilocybin; that measure passed as well.
The majority of those towns that passed these bans have populations of fewer than 10,000, and in some of those towns, just a few hundred voters weighed in. The only town to reject a ban was the tiny town of Nehalem, where residents voted 87-83 against a ballot measure prohibiting psilocybin services. In total, nearly 317,000 voters weighed in on the bans, representing about 14% of people who voted in the election. All in all, 54% of those 317,000 voters elected to ban psilocybin, and 46% voted no.
Oregon Psilocybin Services also announced recently that it had adopted a set of updated rules, originally proposed in October and effective January 1, 2025. As a result of public comment, the agency made clarifications and amendments to some of its proposed rules. For instance, after facilitators complained that a new rule requiring facilitators to only conduct psilocybin sessions at centers might restrict them from participating in harm reduction activities, like providing support at concerts or festivals, OPS clarified that such work did not apply. The program will also now require training programs to receive approval for curricula annually instead of every five years.
Should people with schizophrenia be excluded from psychedelics studies?
Over the past several decades, physicians have raised concerns that psychedelics could trigger or worsen psychosis in people who have a family history of schizophrenia. As a result, people with such a history have been excluded from psychedelics clinical trials. But results from a recent systematic review published in Molecular Psychiatry suggest that the evidence linking psychedelics with the risk of psychosis is “low quality,” and that schizophrenia “might not be a definite exclusion criterion for clinical trials exploring safety and efficacy of psychedelics for treatment-resistant depression and negative symptoms,” according to researchers at the University of Geneva in Switzerland.
The study authors analyzed dozens of papers, and found that overall incidence of psychedelic-induced psychosis in participants across those studies were between 0.002% and 0.6%. In trials that included people with schizophrenia, 3.8% developed long-term psychotic symptoms, and among people who experienced psychedelic-induced psychosis, 13% of them were later diagnosed with schizophrenia. Moreover, the authors write that most of these instances of psychosis occurred in people who used illicit psychedelics. But they also note that many of these studies did not conduct not high-quality research and that more data are needed before determining if it is safe to include individuals with schizophrenia in future psychedelics research. “The current findings warrant further studies,” they write, but “a conservative approach is recommended until further data is available.”
Oregon law requires psilocybin clients receive the drug at a licensed service center — but for some people, disability or illness prevents them from traveling to a center. For Oregon Public Broadcasting, I reported on how Oregon psilocybin facilitators are suing the Oregon Health Authority for the right to provide terminally ill clients with psilocybin services in their homes or in a hospice setting.
Two months before Naropa University’s psilocybin facilitator training program was set to begin, the Boulder-based school announced the program’s cancellation. Naropa President Chuck Lief told Boulder Weekly that the school’s insurer “decided that they were not comfortable with the training happening through the university.” Naropa is looking to offer the same course with the same instructors through “a new entity.”
An Egyptian jar dating to the second century B.C. was used in rituals involving psychotropic plants, researchers wrote in the journal Scientific Reports.
Psychedelic Alpha’s Josh Hardman interviews former FDA director-turned-MindMed Vice President Javier Muniz about the FDA’s approach to psychedelics and why Lykos’s MDMA application failed.
For the London Review of Books, author Mike Jay pens a dispatch from an exhibit of textiles and ceramics from the Shipibo-Konibo people of Peru, “whose art is intimately connected to their use of ayahuasca,” and an accompanying exhibit of international drug artifacts called “Power Plants: Intoxicants, Stimulants, and Narcotics.”
Emory University is launching a study of psychedelic practices and philosophies in the Jewish community.
In September, the Detroit police raided the Psychedelic Healing Shack, a branch of the Sugarleaf Church, and seized 99 grams of psilocybin mushrooms, as well as 10 grams of marijuana. Recently, owner Robert Pizzimenti tells The Detroit Metro Times that he will reopen, because “it’s our religious freedom to have these psychedelics.”
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