DEA concludes hearing on 2 psychedelic research compounds; healthcare professionals enthusiastic but not so knowledgeable about MDMA & psilocybin; New association for “prescription psychedelics"
Plus: Vermont lawmakers conclude state is not ready for psilocybin, and psychedelics stocks get a boost after Trump nominates RFK Jr.
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.
DEA concludes hearing on two psychedelic compounds used in research
On Tuesday, the U.S. Drug Enforcement Administration concluded its hearing on a proposal to schedule DOI and DOC, two previously unscheduled psychedelic drugs often used in research. This is the second time the agency has proposed adding DOI and DOC to the list of Schedule I drugs. The DEA withdrew the first proposal after outcry from scientists and other professionals in the psychedelics field, who say the substances are important to their research.
The agency’s second attempt at introducing the proposal has been contentious. During its open comment period, the agency received over 150 comments voicing overwhelming opposition. Several requested the agency hold a hearing, which was originally scheduled for June and then delayed until November due to a lawsuit questioning the constitutionality of the DEA’s rulemaking process. Dozens of researchers submitted evidence and offered testimony for the hearing, and the DEA filed a court motion to dismiss much of it. Paul Soeffing, the U.S. Administrative Law Judge assigned to the case, ruled against the DEA and said that those witnesses should be allowed to testify in the hearing. “To the extent that the Government asserts that any witnesses are providing testimony otherwise irrelevant to the proceedings, and a proper objection is raised in the context of the hearing, then the objection will be ruled upon at that time,” he wrote in his decision.
The hearing began last Tuesday at DEA Headquarters in Virginia, in a small courtroom on the second floor of the building. It was not broadcast online, but after the hearing concluded, we spoke with two neuroscientists who testified against the proposal: Wayne State University’s Alaina Jaster and U.C. Berkeley’s Raul Ramos. Jaster noted the heavy security in the building — “like the airport, but even more locked down” — and the bright blue carpet of the hearing room (“I got used to it by day 3”). Some attendees were federal employees who were interested in the unusual hearing; hearings are rarely scheduled for 10 full business days, and the last major DEA hearings on rescheduling psychedelic drugs were held in 1985, where 16 witnesses testified at hearings held in Los Angeles, Washington DC, and Kansas City that MDMA should not be classified as a Schedule I drug. (The list of witnesses included well-known psychedelics researchers, such as David Nichols, Rick Strassman, and Philip Wolfson.)
The DOI and DOC hearing kicked off with opening statements, and both sides — the DEA and the opposition, which consisted of the Students for Sensible Drug Policy and Ramos — presented their case through calling witnesses. According to Jaster and Ramos, both sides mainly stuck to the arguments they presented in legal documents filed before the hearing: the DEA argued that DOI and DOC have abuse potential and that there is evidence of illegal drug diversion to individuals using the drug in unauthorized ways. The opposition spoke to the importance of using DOI and DOC in drug discovery research and studies of psychedelics’ mechanisms of action.
Both Ramos and Jaster said they were struck by some of what the DEA’s lawyers presented as evidence. While the DEA said their conclusions were based on “recent data,” Jaster said that many relevant publications by people who testified were not included, which called into question how many recent publications were consulted in DEA’s fact-finding. Ramos said the hearing attendees also spent an entire day talking about Reddit: a witness called by the DEA presented a Reddit thread as evidence of DOI’s use and abuse. In that thread, a commenter described a gathering of 200-300 people using DOI. Ultimately, the witness could not prove this gathering really happened. “We had a very interesting conversation about what it means to be a Reddit troller or shitposter, in federal court,” Jaster said. Meanwhile, Ramos said that numbers from the DEA’s database tracking drug seizures show no DOI seizures over the last few years.
There were moments when tensions ran high, with raised voices and pointed questioning. According to Jastor, a DEA lawyer asked her during the hearing if she believed psychedelics should be legal, and whether all drugs should be legal. Jaster told The Microdose in an interview afterwards that she hadn’t prepared to answer such personal questions, but answered yes to both. “I was under oath, I wasn’t going to lie!” she told The Microdose. Later in the hearing, she says, she learned that DEA lawyers had a binder of her tweets. Ramos said that while there were cordial moments between both sides — jokes shared, small talk made — it was surreal to see one of DEA’s lawyers get angry. When a DEA lawyer tried to dismiss a witness by challenging his expertise, the lawyer began shouting and was “red all over,” according to Ramos. “None of this has ever been personal to me; it’s all professional,” Ramos said. “But there were moments where I felt like it was personal for this lawyer.” (The Microdose reached out to the DEA for comment but did not receive a response.)
Now that the hearing has concluded, both sides will have a chance to file a post-hearing brief by January 6. Judge Soeffing will then review the evidence and make a ruling, which will likely not come until several months into the new year. Both Jaster and Ramos said they found Judge Soeffing to be a good listener, who patiently guided attendees through the process. “Obviously, I’m hoping they don’t schedule the drugs and that we’ve set a precedent for future cases,” Jaster said. “But if we don’t win this round, we’re not just going to give up.”
Healthcare professionals enthusiastic but not very knowledgeable about MDMA and psilocybin
A new survey of 900 U.S. healthcare professionals suggests that respondents have limited knowledge about psilocybin- and MDMA-assisted therapy. The research was recently published in Scientific Reports and was led by researchers at Johns Hopkins, who asked practicing healthcare workers — including physicians, nurses, social workers, psychologists, and therapists — to fill out an anonymous online survey, advertised through the Hopkins’ website and social media accounts.
Respondents were asked to assess their own knowledge of psychedelics on a scale of 1-5. The average score for psilocybin knowledge was 4 out of 5, and for MDMA, 3 out of 5; however, that self-assessment did not square with their actual knowledge. The survey asked respondents to identify the risks of psilocybin and MDMA, their mechanism of action, and which indications the drugs could help treat, and despite respondents’ generally high confidence in their own knowledge, only 5.5% of the respondents answered all three questions about psilocybin correctly, and just 1.1% provided correct responses to all 3 questions about MDMA.
The researchers also asked respondents about their openness to using MDMA and psilocybin in clinical settings and whether they believed the drugs have therapeutic promise, which they rated on a scale of 1-5. Respondents were, on average, more enthusiastic about using psilocybin (4.47) with clients than MDMA (3.98) and were more optimistic about psilocybin’s therapeutic promise (4.67) than MDMA’s (4.25).
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New association for “prescription psychedelics”
Psychedelics are not prescription drugs in the U.S., but a new group is hoping to change that. This week, the Association for Prescription Psychedelics announced its official public launch. The group’s purpose is to integrate prescription psychedelic medicines into the healthcare system. Its founding industry members include Lykos Therapeutics, Compass Pathways, MindMed, and B.More, a nonprofit company partnering with New York University researchers to develop synthetic psilocybin as a treatment for alcohol use disorder. The group also has a scientific advisory board, which includes researchers from Johns Hopkins, University of Wisconsin, University of California San Francisco, Cleveland Clinic, and others.
Jon Kostas, the organization’s executive director and CEO of the patient advocacy organization Apollo Pact, says that the group is a natural next step to capitalize on the momentum of psychedelics, particularly in Congress where members have formed a psychedelics caucus and introduced legislation to create psychedelics research funding. To advance legislative efforts, “lawmakers want to see diversity — advocates, nonprofits, biotech companies, universities, patient advocates, researchers,” Kostas told The Microdose. “We wanted to get all the leaders in the space to come together for the greater good, and advocate on behalf of psychedelic research and medicine.” Kostas says the group will look to support efforts to increase federal funding for research, to help members of congress better understand psychedelics issues, and to advocate for issues related to FDA approvals and insurance coverage for psychedelic medicines.
When asked about the incoming Trump administration’s impacts on APP’s work, Kostas said the group was “optimistic and excited.” “It seems like there’s some chatter about psychedelic research from the executive branch in the incoming administration, so we want to serve as the voice of the experts, patients, and people doing the work,” he said.
Vermont lawmakers conclude state is not ready for psilocybin
In May 2024, Vermont lawmakers passed S.114, which created the Psychedelic Therapy Advisory Group. The group was tasked with reviewing the potential role of psychedelics in treating mental health and to make recommendations to the state about the possibility of creating a state-regulated program in which healthcare providers could administer psychedelics in a therapeutic setting. Last week, the group published a report with its findings.
Overall, the group reports they quickly focused their research on psilocybin. They found that existing data were promising but “insufficient to inform the public health impact of legalizing the therapeutic use of psilocybin.” Additionally, group members say it was hard to decide what type of action to pursue: “Because current state models, active legislation, and ballot measures are so varied and new in development, advisory group members found it difficult to conclude which model should be pursued in Vermont.” Overall, the majority of the advisory group did not recommend creating a state program at this time. They did, however, recommend extending the current working group to continue monitoring research and legislative developments, as well as expanding harm reduction and education efforts in the state.
Psychedelics stocks get a boost after Trump nominates RFK Jr.
Last Thursday, president-elect Donald Trump announced his nomination of Robert F. Kennedy Jr. as Secretary of Health and Human Services on X. Kennedy has been a vocal supporter of psychedelics, and after Trump’s announcement, share prices for several psychedelics companies increased. atai, a psychedelics company with offices in the U.S. and Germany, maintains a portfolio of psychoactive drugs, from ketamine and ibogaine to novel psychedelics; it saw its shares increase by around 22%, from $1.34 to $1.64; Compass, a UK-based company developing psilocybin therapies, saw a 13% increase, from $4.85 to $5.51. Cybin, a Toronto-based company working on psilocybin and DMT (16%), and MindMed, a New York-based psychedelics company (11%) also saw increases. For most companies, the boost was short-lived; for instance, a week later, Compass shares were back down to $4.66.
The Ferriss - UC Berkeley Psychedelic Journalism Fellowship offers ten $10,000 grants to print and audio journalists reporting on psychedelics. Applications are open now through January 31.
Colorado’s Arapahoe County issued a press release that it is considering a proposal to regulate where psilocybin businesses can operate in unincorporated parts of the county, and specify that psilocybin businesses “shall not cause off-site odors, smoke, heat, glare, or light that is discernible from off site.”
Oregon’s Jefferson Public Radio visits the state’s “first legal shrooms party,” where licensed facilitators are on hand for support as attendees take psilocybin mushrooms at a Medford psilocybin center called the Shrooms Cafe. The event included a mushroom taco food truck and tunes spun by a live DJ.
MAPS announced that it will be moving forward with Phase 2 trials of smoked cannabis to treat PTSD in veterans. The study had been under partial clinical hold for the last 3 years over concerns from the FDA about the study’s proposed materials and protocols, which the agency said MAPS had not adequately provided safety data for. The organization says it has now reached an agreement with the FDA to continue the study.
The Microdose’s Indigenous affairs contributing writer Joseph Lee has a new book available for pre-order called Nothing More of This Land. In the book, Lee, an Aquinnah Wampanoag who grew up on Martha’s Vineyard, asks what it means to be Indigenous through telling his and his family’s stories and talking with Indigenous scholars, leaders, and artists.
The fitness tracking app Whoop added a function to log psychedelics use to understand how the experience affects user biometrics. (Other loggable events include ice baths, acupuncture, and sex.)
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