Psychedelic Alpha Bulletin – A deep dive into psilocybin for alcohol use disorder

We reported last week on the important Bogenschutz et al study on psilocybin-assisted therapy for alcohol use disorder. This week's edition of the Psychedelic Alpha Bulletin digs deeper into the paper. They write: "In Short:

• A Phase 2a trial of psilocybin-assisted psychotherapy for alcohol use disorder (AUD) found that heavy drinking days decreased by about 80% among those in the psilocybin group.
• This is the largest psilocybin trial published to date, despite the enrolment being around half the number planned (n=93 vs. an original target of 180)
• During follow-up, those in the psilocybin group had around 24% fewer heavy drinking days compared with a reduction of around 10% in the active placebo group.
• Less than 4% of patients with AUD are receiving an FDA-approved medication to treat it.
• Non-profit psychedelic drug developer B.More will continue this line of research via a Phase 2b trial, expected to commence early 2023.

In last week’s Bulletin (#116) we shared a high-level overview of a new study from NYU researchers that’s received a great deal of media attention: Michael Bogenschutz et al.’s psilocybin-assisted psychotherapy for alcohol use disorder (AUD) trial. Participants (n=93) met the DSM-IV alcohol dependence standard, which represents moderate-to-severe alcohol use disorder, and had experienced at least four heavy drinking days in the month preceding treatment. Diphenhydramine, an antihistamine that can cause drowsiness, was used as an active placebo in the study. The high-level finding was that, in the psilocybin group, heavy drinking days decreased by around 80% from baseline. What’s more, this effect seems sustained in many participants: around six months after the drug sessions, rates of abstinence in the psilocybin group were almost double that of the diphenhydramine group. We’re not likely to get any longer-term data from this study comparing psilocybin to the active placebo, as all participants were offered an open-label psilocybin session at week 38 (provided they continued to meet safety criteria, and had participated thus far). There were no serious adverse events in the psilocybin group."

There is then a comments section "Notes and Nuance" which is worth looking at. It concludes "The day after this study was published, non-profit psychedelic drug developer B.More announced that it has received the all-clear from the FDA to commence a Phase 2b clinical trial of its synthetic psilocybin (SYNP-101) in AUD. Michael Bogenschutz will be principal investigator for the trial, which is expected to commence early 2023. B.More, which is led by Carey Turnbull, hopes to enrol 226 patients who will receive either 30mg of the synthetic psilocybin or an active placebo, niacin."

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