DEA seeks to exclude testimony and evidence in case of two drugs used in psychedelic research; The role of therapy in psychedelic therapy; and Portlanders introduce Psychedelic Health Act
Plus: Designing psychedelic placebos and Psyence backs out of Clairvoyant purchase
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 seeks to exclude testimony and evidence in the case of two drugs used in psychedelic research
Since 2022, the U.S. Drug Enforcement Administration has made moves to add two previously unscheduled drugs, DOI and DOC, to the list of Schedule I controlled substances. After outcry from researchers, who use the drugs to understand the mechanisms underlying psychedelics’ effects, the DEA withdrew its proposal. If the two drugs were to be added to the list of Schedule I drugs, getting and using them in research would become more onerous. This year, the agency again proposed scheduling DOI and DOC, and after researchers petitioned the agency to hold a hearing to discuss the proposal, the DEA announced a 10-day hearing in November on this issue. The agency said petitioners could submit testimony and exhibits for consideration.
In late September, the DEA’s attorneys filed a document in the case requesting that specific witnesses and their testimony and the exhibits they submitted to the case by excluded, “on the grounds that much of the proposed testimony and exhibits are incompetent, irrelevant, immaterial, and/or unduly repetitious.”
The filing lays out the eight factors the DEA uses to decide whether a non-controlled substance should be scheduled, which include the drug’s potential for abuse, risks to public health, and scientific evidence of the drug’s pharmacological effects, among other factors. Testimony and exhibits, the filing says, “should be restricted to evidence that is relevant to the factors.” In this case, many witnesses’ testimony largely focuses on the use of DOI and DOC in research, which the DEA claimed “is not relevant to addressing the factors.” Discussion about how scheduling DOI and DOC would affect research “would result in a waste of judicial time and resources,” the agency’s attorneys argue.
The DEA filed a similar motion to exclude researchers’ testimony in 2022, after the agency proposed scheduling five previously unregulated tryptamines which were also used by psychedelics researchers; soon after, the agency withdrew its proposal.
Last week, attorneys representing two of the witnesses the DEA wishes to exclude — the Students for a Sensible Drug Policy (SSDP)’s Science Policy Council, and Raul Ramos, a University of California, Berkeley postdoctoral fellow studying the neural mechanisms of the actions of psychedelics — filed a legal document opposing the government’s motion, in which they argue that harm to research is relevant to scheduling determinations.
“Our goal is to ensure that the most qualified experts are able to present evidence on the broader implications of this decision,” said SSDP’s Director of Strategy and Development Gina Giorgio. “We question the fairness and credibility of a DEA-led trial that excludes the world’s foremost experts from participating in the discussion.”
Examining the role of therapy in psychedelic-assisted therapy
In discussions of psychedelic-assisted therapy, the focus often turns towards the psychedelic drugs: do they work in helping participants or clients? A new op-ed published in JAMA Psychiatry argues that the psychotherapy piece needs much more attention. Specifically, psychologists Ioana Cristea, Pim Cuijpers, and Joar Halvorsen analyze the FDA’s recent rejection of MDMA-assisted therapy as a treatment for PTSD, and argue that examining the psychotherapy component of MDMA-assisted therapy “plays a critical role in assessing the validity of the trials.”
They note that the psychotherapy standards framework developed by MAPS to accompany MDMA in clinical trials “is not standard of care, and has not been studied previously for PTSD or any other mental disorder.” With no previous track record of the therapy’s efficacy, evaluating the MAPS clinical trial results is challenging — how much were results driven by the drug, MDMA, versus the psychotherapy used with it? “MDMA-assisted psychotherapy is a combination of 2 experimental elements, each of unknown efficacy or safety,” the authors write.
Additionally, they argue that MAPS’s training manual for the psychotherapy used in its clinical trials gives facilitators a lot of latitude to determine their therapeutic approach. Some elements, such as the concept of helping a participant connect with their “inner healing intelligence” to heal themselves, “lack empirical evidence and are not even operationalized to allow measuring. They are not derived from any tested or testable theory and are not recommended by clinical practice guidelines,” they write. As a result, it’s unclear how much variability there was in the type of therapy patients received and how to determine the effect of that therapy.
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Portlanders introduce Psychedelic Health Act
At the Portland Psychedelic Symposium last weekend, Oregon activists announced a new ballot initiative called the Portland Psychedelic Health Act. The act is led by the Portland Psychedelic Society, and it proposes that “the investigation, arrest, and prosecution of individuals engaging with natural psychedelic substances will be among the City of Portland’s lowest law enforcement priorities.”
Oregonians voted to pass Measure 110 in 2020, which removed criminal penalties for the possession and use (but not distribution) of limited quantities of drugs including fentanyl, methamphetamine, MDMA, psilocybin, and LSD. But this year, the Oregon legislature passed a bill that essentially reversed that measure. According to the Portland Psychedelic Health Act’s website, the act was established to protect psychedelic use in the wake of these changes. The Microdose reached out to the Portland Psychedelic Society and the act’s organizers for more information but did not receive a response by publication time.
Designing psychedelic placebos
Psychedelics are mind-altering drugs — above some certain dose, people typically know when they’re tripping versus when they’re not. As a result, it is notoriously difficult to create a true “control” condition in psychedelic studies; if people know they’ve been given an inert substance instead of a psychedelic, their expectations of their experience will inevitably change. In a new paper published in Nature Mental Health, University of Maryland researcher Luana Colloca and Massachusetts General Hospital psychiatrist Maurizio Fava dig into what an effective control condition in psychedelic studies might look like.
The authors detail a number of approaches for creating placebo conditions in clinical trials, such as providing an inert placebo, an active placebo, and varying the doses of the drug under study instead of using a placebo. Perhaps most interestingly, they suggest possible strategies to use in future studies. Some require complex study design with multiple-stage studies, deception, incomplete disclosure of research methods, and psychedelically naive participants. Other ideas proposed included using anesthesia before dosing patients, or using virtual reality environments to simulate the psychedelic experience.
Psyence backs out of Clairvoyant purchase
Three weeks ago we reported that psychedelics company Psyence was acquiring psilocybin company Clairvoyant. Psyence has now announced it “has decided not to proceed with the acquisition at this time” after completing “due diligence.” Due diligence is a process during which buyers analyze aspects of the company they’re purchasing, such as tax liabilities, intellectual property portfolio, and leadership. As part of the original deal, Psyence had agreed to take on Clairvoyant’s $1.8 million in debt.
Despite the buzz around psilocybin mushrooms, they remain illegal. Still, plenty of businesses are openly selling them, and for the Los Angeles Times, drugs journalist Michelle Lhooq explores this new above-ground wellness marketplace. “Consumer demand for psychedelic experiences remains, and players in an illegal market who were once cautiously discreet are becoming bolder,” she writes.
As Colorado is on the cusp of starting its psilocybin program, many aspiring entrepreneurs have expressed concerns about licensing fee structures included in the state’s draft rules, Tiney Ricciardi reports in The Denver Post. Healing centers that hold several psilocybin sessions a month will need to pay $3,000 with its license application, which will ramp up to $12,000 by 2027.
Mark Chavez, a San Diego doctor who was charged with a felony for illegal distribution of ketamine to the late actor Matthew Perry, pleaded guilty last week, reports the Associated Press. He is the third person in the case to do so.
You’re all caught up! Monday is Indigenous Peoples' Day, so we’ll be rerunning a 5 Questions interview with physician and medical researcher Sylver Quevedo on connecting Indigenous ways of knowing and western science. This interview was originally published before many of you were subscribers. We hope you enjoy it.
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