Clairvoyant Therapeutics, a Canadian drug developer, has initiated the first of 15 planned sites for the Phase 2 CLARITY clinical study investigating the use of magic mushroom molecule psilocybin to treat alcohol use disorder (AUD).
The randomized, placebo-controlled study will evaluate the safety and efficacy of 25 mg of synthetic psilocybin with Motivational Enhancement Therapy (MET), a counseling method designed to elicit an internally motivated behavior change regarding substance abuse.
The CLARITY trial has won regulatory approval. Clairvoyant is currently working on obtaining regulatory approval to expand the trial to a number of EU countries.
Edmonton, Alberta-based Clairvoyant Therapeutics aims to win regulatory approval for psilocybin therapy in the EU, UK and Canada by 2026.
The CLARITY trial provides “a great opportunity to advance the science on psilocybin than has historically been done,” said Greg Engel, Clairvoyant Therapeutics’ director, in a January podcast.
Researchers first tested psychedelics psilocybin and LSD to treat AUD in the 1950s and 1960s.
In recent years, psilocybin, in particular, has emerged as a potential treatment for mental health disorders, including AUD.
The trend has elicited mixed reactions from psychiatrists. A trio of skeptical psychiatrists observed in JAMA Psychiatry in 2021 that there was little psychedelic research supported by federal agencies such as the National Institutes of Mental Health (NIMH) or major pharmaceutical or biotech companies. They also observed that the tendency of many psychedelic companies to develop patented proprietary versions of psychedelic compounds could limit the generalizability of clinical outcomes.