Psychedelics and the social cure; Industry shake-ups; Tracking adverse events
Plus: Psychedelic tofu?
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.
Psychedelics and the social cure
Psychedelics have long been used in group settings, from ceremonial use in Indigenous cultures to the underground rave scene and during festivals like Burning Man. In a new “Perspective” article published in Nature Mental Health researchers propose that group-based psychedelic therapies should be further developed, and posit that group psychedelic experiences may positively enhance the effects of the drugs.
Their argument draws on previous psychology research suggesting that group settings can help people find meaning and support in their peers. Strong feelings of trust and belonging between group members could “interact with each other to make psychedelic-assisted therapies more effective,” they write. Group psychedelic experiences would provide a more supportive and controlled setting for people who might otherwise turn to the underground, where they could encounter inconsistent dosing, drug contamination, and a lack of support for adverse events — but, they note, therapists will need to be properly trained to manage group dynamics. “Our hope is that the strategies and directions that we have proposed here can pave the way to a more unified, theoretically coherent approach to group-focused psychedelic research and practice,” they write.
Psychedelic industry shake-ups
Since Lykos Therapeutics failed to receive FDA approval for MDMA, the psychedelics industry has seen some major shake-ups. As we reported last month, Lykos announced that it had laid off around 75% of its workforce within days of the FDA’s decision; MAPS also said that it laid off 33% of its staff. Last week, Lykos changed up their top leadership; former Jannsen executive David Hough became Chief Medical Officer and Mike Mullette moved from Lykos COO to CEO, while Amy Emerson stepped down as CEO.
Recently, psychedelics company Cybin announced to shareholders that it was consolidating its shares (a “reverse split”), such that 38 existing shares would become the equivalent of one new common share. (Companies sometimes use this as a strategy to ensure that the value of the stock price does not drop so low it results in removal from a stock exchange.) Since the announcement, the company’s stock has steadily dropped. In the last week, psilocybin company Psyence announced it was acquiring Clairvoyant, a company that has been studying the use of synthetic psilocybin as a treatment for alcohol use disorder, for just $500,000 (in shares, not cash). Psyence will also pay around $1.8 million “to settle [Clairvoyant’s] liabilities, which consist primarily of clinical trial costs,” according to its press release.
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Tracking adverse events
Researchers should anticipate and track adverse effects in psychedelics research, a group of Maryland-based scientists argue in a paper recently published in Psychedelic Medicine. For years, the field has been focused on the potential benefits of psychedelics, but the scientists argue that it’s time to pay more attention to understanding the risks. “The extent of risks related to psychedelic use have yet to be fully delineated, including information about predictors of adverse events or adverse event severity and duration,” the authors write. Measurements of these risks are not always included in standard reporting systems, which may require updating to capture the full range of participants’ experiences.
Two authors on that paper, both Johns Hopkins researchers, also recently published a review and meta-analysis of adverse events in LSD, psilocybin, and DMT studies in the journal JAMA Psychiatry. In the 114 studies they reviewed representing over 3500 participants, 4% of participants with preexisting neuropsychiatric disorders experienced serious adverse events requiring psychiatric intervention. Serious adverse events included worsening depression, psychosis, suicidal behavior, and convulsive episodes. Participants who had not been diagnosed with such disorders reported none of these serious effects, but did report other unpleasant outcomes such as headache, nausea, and anxiety. Most importantly, the researchers say that 70% of the studies they analyzed reported only suspected adverse reactions — “those deemed possibly attributable” to the drug — rather than all adverse events that may be undesirable to participants, even if the causal relationship to the drug is unclear. That could mean studies provide an incomplete picture of these adverse events, the authors say, and the lack of standardized questionnaires or methods for collecting data on adverse events could contribute to bias in reporting negative effects.
A psychedelic like tofu?
Dillan DiNardo, CEO of psychedelic start-up Mindstate Design Labs, announced the company received approval from the U.S. Food and Drug Administration and the European Medicine Agency to begin human clinical trials studying the compound 5-MeO-MiPT. The well-known psychedelic chemist Alexander and his wife Ann Shulgin were the first people known to have synthesized the drug in the 1980s. Psychonauts call 5-MeO-MiPT “moxy.” Mindstate chose to develop the substance because 5-MeO-MiPT is “a psychedelic tofu,” according to DiNardo: Just as tofu takes on the flavors of any dish it’s put in, the drug takes on the properties of the other drugs with which it’s administered. This week, DiNardo told The Washington Post that 5-MeO-MiPT would not be “the entire medicine,” but rather “the first part of a number of different medicines that we’ll be making.”
The drug was one of the five tryptamines the U.S. Drug Enforcement Agency proposed banning in 2022, but the agency withdrew their proposal to ban the substances after outcry from psychedelics researchers and companies.
Join me (Jane C. Hu) and fellow journalists Deena Prichep, Arielle Duhaime-Ross, Lizzy Acker and Shayla Love for a virtual panel discussion on “The New Psychedelic Beat: Unraveling Oregon’s Drug Policy Story” on September 25, 2024 1:00-2:00 pm PT. Register at the link. Co-sponsored by the UC Berkeley Center for the Science of Psychedelics and the Graduate School of Journalism.
Last Friday, the Reagan-Udall Foundation held a public meeting to discuss the advancement of treatments for PTSD, which includes psychedelics. The foundation is a non-profit created by Congress to advance the U.S. Food and Drug Administration’s work, and the meeting featured speakers from the U.S. Department of Veterans Affairs, the FDA, the Department of Defense, and the Department of Health and Human Services. For more, Wayne State postdoctoral researcher Alaina Jaster wrote a full breakdown of the event on Medium.
In The Guardian, Shayla Love profiles a clinic in Berlin that treats people experiencing HPPD, or hallucinogen persisting perception disorder.
Psychoactive drugs have been used for thousands of years – not just for healing, but also for “building connections within communities, sacred rituals, palliative care, exploring consciousness, facilitating creativity and hedonism,” according to a piece in the BBC that asks scholars about the substances’ roles in Indigenous culture.
The CEO of a small-time psilocybin mushroom company was arrested recently on charges of securities fraud. According to the U.S. Department of Justice, Julius Jenge claimed his company sold psilocybin, but the federal government alleges he issued misleading information in their positive press releases and defrauded investors. He was arrested at the Ronald Reagan airport, where he was catching a flight to Tanzania.
Elastic, a new magazine on psychedelic art and literature,is gathering submissions for their first issue on the theme of dying. Submit pitches or finished work by September 23.
Are you making a documentary about psychedelics? Apply for funding by October 15.
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