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

Alcohol Use Disorder Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05646303
• Other study ID #: CLA PSY 201
• Status: Recruiting
• Phase: Phase 2
• Start date: May 2, 2022
• Est. completion date: October 2024

Study information

• Verified date: September 2023
• Source: Clairvoyant Therapeutics
• Contact: Teresa Yan
• Email: hello[@]clairvoyantrx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: October 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Drug:
• Psilocybin
Psilocybin and psychotherapy
• Placebo
Placebo and psychotherapy

Locations

Country	Name	City	State
Canada	Sabi Mind	Calgary	Alberta
Canada	Centricity Research	Halifax	Nova Scotia
Canada	MacAnxiety Research Centre	Hamilton	Ontario
Canada	Okanagan Clinical Trials	Kelowna	British Columbia
Canada	Department of Psychiatry, Queen's University	Kingston	Ontario
Canada	Centre for Neurology Studies	Surrey	British Columbia
Canada	Centre for Addiction and Mental Health	Toronto	Ontario
Canada	University of British Columbia, Department of Psychiatry, BRAIN Lab	Vancouver	British Columbia
Finland	Research Center Oxidi Oy / Addiktum Oy	Helsinki
Finland	A-Klinikka	Kouvola
Finland	Mentacare Oy	Oulu
Finland	Addiktum Oy	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Clairvoyant Therapeutics	Optimapharm

Countries where clinical trial is conducted

Canada,  Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the number of Heavy Drinking Days	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).	8 weeks