A 24-Week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Clinical Trial to Evaluate Efficacy and Safety of Psilocybin-Assisted Psychotherapy in Adults with Alcohol Use Disorder (AUD)

This double-blind, placebo-controlled trial (n=160) aims to evaluate the efficacy and safety of Psilocybin-Assisted Psychotherapy (25mg) in adults with Alcohol Use Disorder (AUD).

Conducted by Clairvoyant Therapeutics Inc. and based in Finland, Canada, and Bulgaria, the study focuses on the potential benefits of psilocybin in reducing heavy drinking days (HDD) over an 8-week treatment period.

Participants, comprising 150 adults aged 18-64 and 10 elderly individuals aged 65 or above, must meet DSM-5 criteria for moderate to severe AUD. They should have a history of heavy drinking, express a desire to reduce or stop alcohol consumption, and be willing to undergo behavioural and medicinal treatments. Exclusions include certain psychiatric disorders, recent medication use, and significant medical conditions affecting hepatic, renal, or cardiovascular function.

The primary endpoint is the mean number of HDD measured monthly, with secondary endpoints covering various aspects of alcohol consumption, safety parameters, and psychedelic experiences during therapy sessions.

The trial, named CLARITY, commenced in June 2022 and is ongoing, with an estimated completion in May 2023 (but currently still ongoing).

Topic Alcohol Use Disorder Addiction
Compound Psilocybin Placebo
Country Finland Canada
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Trial Details



Trial Number

Sponsors & Collaborators

Clairvoyant Therapeutics
Clairvoyant Therapeutics is a clinical-stage Canadian biotech company focused on psychedelic therapy drug development for substance use disorders.

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