Another Breakthrough Therapy Designation for a psychedelic drug from the FDA; A critique of the mixing of psychedelic science and spirituality at Johns Hopkins; The patient-therapist bond
Plus: The State of Psychedelics in Utah and Kentucky, Oregon’s recriminalization
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.
Cybin receives FDA Breakthrough Therapy Designation for a psilocybin analog
Last week, pharmaceutical company Cybin announced that their psilocybin analog received Breakthrough Therapy Designation by the U.S. Food and Drug Administration to treat major depressive disorder. (The FDA grants such designations to “expedite the development and review of drugs for serious or life-threatening conditions.”) The news came just a week after the FDA also gave the same designation to MindMed for their LSD formulation MM120. Cybin becomes the fifth entity to receive FDA Breakthrough Therapy Designation for a psychedelic drug.
In their announcement, Cybin also included a summary of preliminary results from a Phase 2 trial using their psilocybin analog, which they call CYB003, to treat major depressive disorder. From the graphs Cybin provided, it appears the study included 23 participants who were given two doses of either 12 or 16 milligrams of CYB003. According to the company, 75 percent of participants in the 16 milligram condition showed an improvement in depression scores — which, according to Cybin’s graphs, represents just 6 participants. The results have not yet been peer-reviewed.
A critique of the mixing of psychedelic science and spirituality at Johns Hopkins
The late Johns Hopkins professor Roland Griffiths is often credited with resurrecting the area of psychedelic research with his 2006 study on psilocybin and mystical experience. Near the end of his life, Griffiths was open about his own psychedelic use; many psychonauts were drawn to Griffiths’s work and identified with his belief that the drugs could change humanity.
In a New York Times piece published Thursday, several former colleagues and collaborators raised concerns that Griffiths’s spiritual beliefs may have biased his work. The piece alleges that the Mystical Experience Questionnaire, or MEQ, that participants were asked to fill out may have “primed” volunteers to report high levels of mystical experience. The piece also includes concerns about Griffiths’s work with philanthropist and psychotherapist Cody Swift, who contributed funding to his research but also worked as an assistant guide in a research study and co-wrote studies with Griffiths.
Many of Griffiths’ research practices, as highlighted in the New York Times piece, are not uncommon among psychedelic researchers: many use the MEQ as a standard questionnaire and take pains to design inviting lab spaces, and some are known to collaborate with funders. So far, no researcher has faced repercussions for such practices, but leveling these critiques at one of the best-known psychedelic researchers could have the power to shift norms and ethics of the field. Other allegations made in the piece, such as not being forthright about the suicide of a man who had participated in a study, and asking a study participant to reconsider a questionnaire response are more troubling, and could constitute scientific misconduct.
A federal scientific research institute awards $14 million grant to a biotech startup for a ibogaine analog
Pharmaceutical start up company Gilgamesh announced last week that it received a $14 million grant from a drug-focused research institute that is part of the National Institutes of Health called the National Institute on Drug Abuse to develop an ibogaine analog for treating addiction. Researchers have been studying the therapeutic potential of ibogaine, a psychoactive substance derived from plants like the iboga bush. Last year, the state of Kentucky proposed spending $42 million on research into the drug. But ibogaine has been linked to adverse cardiac effects, which is significant not only for would-be users but also for would-be drug developers, who may face hurdles in obtaining approvals from the FDA and institutional review boards to study the drug.
Gilgamesh claims that their ibogaine analog, which they call GM-3009, may reduce some of those cardiac risks. In a press release, the company says that the federal funding will “seek to confirm that GM-3009 eliminates the cardiovascular risks associated with ibogaine.”
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Does the patient-therapist bond matter?
To date, most psychedelics studies include not just psychedelic drugs, but also therapy or counseling. Researchers disagree about how much therapeutic intervention plays a role in patient outcomes; some say it is essential, while others, some of whom are affiliated with psychedelic start up companies, have argued that therapy may not be a necessary part of psychedelic treatment. Still others are developing psychedelic treatments without any kind of psychotherapeutic intervention at all. A study published recently in PLOS One suggests that therapy may, in fact, play an important role in psilocybin-assisted therapy for major depressive disorder. In a study of 24 participants with MDD, those who reported stronger alliance, or “sense of collaboration between patient and client,” with their therapist were more likely to show improvements in their depression scores after two psilocybin dosing sessions. Stronger ratings of therapeutic alliance during the study’s final preparation session were correlated with improved depression scores for 12 months after the study.
“This model supports many long-held assumptions, in both the traditional and contemporary use of psychedelics, about the importance of the therapist or facilitator in a therapeutic psychedelic experience,” the authors, all researchers at The Ohio State University and Johns Hopkins, write. “Although assumptions about the importance of facilitators through altered states of consciousness are pervasive, they have only recently been empirically substantiated.” The authors write that future research might explore how to improve patient-therapist alliance, including “assessment and repair of alliance ruptures” and studying what factors create a strong bond in the first place.
The State of Psychedelics: Utah legislature passes bill allowing healthcare systems to prescribe psilocybin and MDMA treatment, KY Attorney General asks opioid commission to “step back” from $42 million ibogaine proposal
Last week, the Utah legislature passed Senate Bill 266, which would create a pilot program allowing healthcare systems in the state to prescribe psilocybin and MDMA treatments through 2027. It awaits action by the governor.
In 2023, Kentucky Opioid Abatement Advisory Commission chair W. Bryan Hubbard proposed spending $42 million of the state’s opioid settlement funds on ibogaine research. In the state’s November 2023 election, Daniel Cameron, the attorney general who appointed Hubbard, left office. The new Attorney General, Russell Coleman, took office in January and replaced Hubbard with former DEA official Chris Evans, sparking speculation that the committee’s ibogaine proposal was unlikely to move forward. At an Opioid Abatement Advisory Commission meeting last week, the Associated Press reported that Coleman asked the committee to halt the ibogaine proposal. “I respectfully ask this commission to step back from previous proposals to allocate $42 million to ibogaine research and the unproven and incredibly expensive clinical trial,” he said.
Oregon recriminalizes some drugs
In early March, Oregon legislators passed House Bill 4002, which recriminalizes the drugs that were decriminalized in 2020 by the state’s Measure 110. Measure 110 was passed in November 2020, at the same time that Oregonians voted to pass Measure 109, which established psilocybin services in the state. Measure 110 took a radical approach to controlled substances, with penalties for possessing drugs like cocaine, heroin, and fentanyl of just a $100 fine, which the state would waive if the accused underwent a health assessment.
HB 4002 was a reaction to increased fentanyl overdose deaths and to concerns over open drug use in the state. It should be noted that there is a lack of evidence that Measure 110 played a role in the uptick in deaths. The new bill lays out limits and sentencing guidelines for possession of heroin, fentanyl, cocaine, methamphetamine, psilocybin, LSD, and MDMA. The bill has been delivered to the governor, who has said she will sign it.
Around a fifth of people trained in one psychedelic guide program are executive coaches, which Bloomberg describes as an “unregulated $5 billion field.” Business professionals are now seeking out psychedelics in hopes of achieving “peak performance” in the workplace.
Fierce Biotech writes that a psychedelic start-up called Mindstate Design Labs has submitted an Investigational New Drug application to the FDA for a psychoactive substance called 5-MeO-MiPT. (The psychedelic is a chemical cousin of 5-MeO-DMT, and was one of five previously unscheduled tryptamines the DEA proposed scheduling in January 2022. The agency withdrew its proposal following outcry from psychedelic researchers and companies.)
For BBC Sounds, Ferriss - UC Berkeley Psychedelic Journalism fellow Ben Wyatt dives into Oregon’s psilocybin program.
The Washington Post summarizes the history of ibogaine research and spotlights advocates pushing for its therapeutic use.
Knowable Magazine talks with drug law expert Robert Mikos about the legal future of psychedelics.
On March 27, the UC Berkeley Center for the Science of Psychedelics is hosting an online event featuring a panel of psychedelic researchers discussing the evolution of psychedelics, their mechanisms of action, and their healing potential.
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