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

Phase 2

Active, not recruiting

• Conditions: Alcohol Use Disorder
• Interventions: Drug: Placebo; Drug: Psilocybin

• Registration Number: NCT05646303
• Lead Sponsor: Clairvoyant Therapeutics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-02
• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2022-12-02
• Study First Posted: 2022-12-12
• Status Verified: 2023-09
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15
• Primary Completion: 2024-08-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Moderate to severe diagnosis of AUD as measured by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria using Structured Clinical Interview for DSM-5 by the investigator.
• Expressed a wish to reduce or stop alcohol consumption.
• Generally healthy with no unstable medical conditions, as determined by medical history, physical examination, routine blood labs, electrocardiogram, urine analysis, and urine toxicology.

Exclusion Criteria

• Diagnosed with or having a family history of any of the following concomitant psychiatric disorders: schizophrenia or prodromal symptoms, any bipolar disorder, obsessive compulsive disorder, or other psychotic episode. Recent (within last 12 months) diagnosis of a major depressive disorder (MDD) (HAM-D score >19), treatment resistant depression (TRD), post-traumatic stress disorder (PTSD), panic disorder, or eating disorders.
• Subjects deemed unfit for psilocybin-assisted therapy based on the assessments made during psychotherapy sessions prior to the first psilocybin-assisted psychotherapy session.
• History of hallucinogen use disorder, or any use in the past 1 year, or >25 lifetime uses.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	2 oral doses of placebo (microcrystalline cellulose) capsules
Psilocybin	Psilocybin	2 oral doses of 25mg psilocybin capsules

Primary Outcome Measures

Name	Time	Method
Reduction in the number of Heavy Drinking Days	8 weeks	Mean number of HDD from V5 (baseline) measured monthly (4 weeks) over the treatment period (Week 8), where heavy drinking is defined as the consumption of ≥60 g alcohol/day (if male) or ≥40 g alcohol/day (if female).

Trial Locations

Locations (12)

MacAnxiety Research Centre; 🇨🇦 Hamilton, Ontario, Canada

Department of Psychiatry, Queen's University; 🇨🇦 Kingston, Ontario, Canada

Okanagan Clinical Trials; 🇨🇦 Kelowna, British Columbia, Canada

Centricity Research; 🇨🇦 Halifax, Nova Scotia, Canada

Mentacare Oy; 🇫🇮 Oulu, Finland

Sabi Mind; 🇨🇦 Calgary, Alberta, Canada

University of British Columbia, Department of Psychiatry, BRAIN Lab; 🇨🇦 Vancouver, British Columbia, Canada

Centre for Neurology Studies; 🇨🇦 Surrey, British Columbia, Canada

Research Center Oxidi Oy / Addiktum Oy; 🇫🇮 Helsinki, Finland

Addiktum Oy; 🇫🇮 Turku, Finland

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada

A-Klinikka; 🇫🇮 Kouvola, Finland