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Psychedelic Bulletin #124: MAPS Wraps Second Phase 3 MDMA Trial; Preparing for atai’s PCN-101 Results; Tactogen Launches Community Funding Round

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Psilocybin is “an MDMA-based medicine”, According to Conservative MP  |  In response to a question put to the Home Office by Labour MP Charlotte Nichols, a conservative MP described psilocybin as “an MDMA-based medicine”. While the ‘MDMA-based’ bit is way off, the fact that the Tory described it as a “medicine” might be useful at a later date(!)

“That’s why I look a bit baffled when the camera cuts back to my face”, Nichols said in reply to a tweet. She was clearly disappointed by the lack of subject matter expertise on display from the other bench; audibly uttering, “no it isn’t” during the session. The MP explained that she has sent him “a proper briefing” alongside a meeting request.

84 Years Since Hofmann’s First Synthesis of LSD  |  In a 1996 talk on his discovery, he pondered “what roles planning and chance play in the realization of the most important events in our lives.” On his discovery of LSD, more specifically, he wondered: “just how much was destiny, how much free will?”

NIMH Issues Guidance for Psychedelic Research  |  NIMH has published guidance for research involving psychedelics and related compounds.

TL;DR: In animal studies, NIMH prioritises the reverse translational approach. i.e., it’s interested in research that will seek mechanisms of action based on observations in humans. On the translational/clinical side of things, NIMH identifies a number of methodological issues that should be addressed in any study designs or grant applications.

Read a thread from Josh Hardman breaking down the guidance.

The Ethics of Skipping the Trip |  A journal article from David Yaden, Brian Earp and Roland Griffiths explains that the authors are “broadly supportive” of efforts to produce non-hallucinogenic (or, “nonsubjective”, in their words) psychedelics, but argue that classic psychedelics should be “considered the default and standard of care.”

Here, Yaden et al. are making an ethical argument, which essentially hinges on the argument that to prescribe a “nonsubjective” by default is to potentially withhold “typically positive, meaningful, and therapeutic experiences” from most patients. As such, the authors argue that people should be at least offered classic psychedelics as the default treatment option (for those who aren’t contraindicated), while also allowing patients to choose the non-hallucinogenic option if they prefer.

Two Commentary pieces were published alongside Yaden et al.’s paper. Bioethicists Andrew Peterson and Dominic Sisti elucidate five arguments relating to the use of non-hallucinogenic psychedelics in psychiatry, and Delix Therapeutics’ Kurt Rasmussen and David Olson also grapple with the question.

German Ministry of Education and Research Approves Additional €2.6m for Psilocybin Depression Study  |  The Efficacy and safety of psilocybin in treatment-resistant major depression (EPIsoDE) administers two psilocybin sessions at six-week intervals. More here.

COMPASS’ Published Results Take its Psilocybin into Final Phase of Clinical Trials  |  This week, Josh wrote a piece on COMPASS Pathways’ Phase 2b publication and Phase 3 program in Lucid News. It draws focus on the company’s digital tools.

Latest Filings Show Just CAD $89k Cash on Hand at Mydecine  |  CEO and COO remuneration was still at around $277k for the 9mo period (c.$370k per annum), while $467k was spent on research in the most recent quarter.

Finland Gives Go-Ahead to Psilocybin for Alcohol Use Disorder Study  |  Canadian psychedelic drug developer Clairvoyant Therapeutic has received permission from the Finnish Medicines Agency to commence a trial of 160 participants, 50 of whom will be Finnish.

Virtual Event: State of Play: Companies and Clinical Trials  |  Our Editor, Josh Hardman, will join Dick Simon (Sensorium Therapeutics CEO) to discuss the current state of psychedelics companies and trials, hosted by MindSite News Founding Editor Rob Waters. December 1st, 10am PT: register here.

Assorted Reading

The Economist: Psychedelic medicines are expanding into the public consciousnessNew Scientist: Psychedelic drugs may reopen critical learning periods in the brainShondaland: Is Psychedelic-Aided Therapy a Mental Health Game Changer?NZ Herald: Psychedelics In The Suburbs: Why Are Ordinary New Zealanders Seeking Extraordinary States Of Consciousness?The Week: Are psychedelics the next big legalization battle?Labiotech: Beckley Psytech completes treatment resistant depression and alcohol use disorder studyVideo: Bill Maher asks Governor of Colorado Jared Polis about Prop 122, which decriminalized some psychedelics & will establish legal psilocybin service. Polis steeped the discussion in language of helping veterans, explaining it’s not really about just having fun. “It’s more like the medical side”, Polis explained. He said that FDA studies will take “decades or years” and “comes out costing a thousand dollars a pill, it’s ridiculous.”American Society of Clinical Oncology: Cancer Care Must Address Mental Health, and Psychedelic-Assisted Therapy May Help

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