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
Visit trial
Status Active, not recruiting
Results Published No
Start date 01 June 2022
End date 31 May 2023
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 160
Sex All
Age 18-
Therapy Yes

Trial Details

This ongoing double-blind trial (n=160) by Clairvoyant Therapeutics Inc. aims to assess Psilocybin-Assisted Psychotherapy's efficacy and safety in adults with Alcohol Use Disorder (AUD). Conducted across Finland, Canada, and Bulgaria, it evaluates the reduction of heavy drinking days over 8 weeks. Participants, aged 18-64 and over 65, must meet AUD criteria, express a desire to reduce alcohol consumption, and undergo behavioural and medicinal treatments. Exclusions include certain psychiatric disorders and recent medication use. The trial began in June 2022 and is expected to conclude in May 2023.

NCT Number 2021-006200-33

Sponsors & Collaborators

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

Data attribution

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