NCT05646303

Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)

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)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Clairvoyant Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to investigate treatment with psilocybin and psychotherapy for the treatment of people with Alcohol Use Disorder (AUD). The main question\[s\] it aims to answer are: * Does treatment with psilocybin and therapy help reduce alcohol consumption more than placebo and therapy? * Is treatment with psilocybin and therapy safe for participants? Participants will * Attend 13 study visits * Take part in therapy sessions including 2 treatment sessions with either psilocybin or placebo * Record their daily alcohol consumption on study specific device Researchers will compare psilocybin and placebo groups to see if alcohol consumption is decreased.

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Psilocybin	Psilocybin and psychotherapy
DRUG	Placebo	Placebo and psychotherapy

Timeline

• Start date: 2022-05-02
• Primary completion: 2024-08-31
• Completion: 2024-12-31
• First posted: 2022-12-12
• Last updated: 2024-08-15

Locations

12 sites across 2 countries: Canada, Finland