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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Drug: Psilocybin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3C 0J7
      • Sabi Mind
  • British Columbia
    • Kelowna, British Columbia, Canada
      • Okanagan Clinical Trials
    • Surrey, British Columbia, Canada
      • Centre for Neurology Studies
    • Vancouver, British Columbia, Canada, V6T 1Z3
      • University of British Columbia, Department of Psychiatry, BRAIN Lab
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3S 1N2
      • Centricity Research
  • Ontario
    • Hamilton, Ontario, Canada, L8S 1B7
      • MacAnxiety Research Centre
    • Kingston, Ontario, Canada
      • Department of Psychiatry, Queen's University
    • Toronto, Ontario, Canada, M6J 1H4
      • Centre for Addiction and Mental Health
• Finland
  • Helsinki, Finland
    • Research Center Oxidi Oy / Addiktum Oy
  • Kouvola, Finland, 45100
    • A-Klinikka
  • Oulu, Finland
    • Mentacare Oy
  • Turku, Finland
    • Addiktum Oy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psilocybin; 2 oral doses of 25mg psilocybin capsules	Drug: Psilocybin; Psilocybin and psychotherapy
Placebo Comparator: Placebo; 2 oral doses of placebo (microcrystalline cellulose) capsules	Drug: Placebo; Placebo and psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Clairvoyant Therapeutics
• Collaborators: Optimapharm
• Investigators: Principal Investigator: Hannu Alho, MD, Addiktum Oy

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: December 2, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism; Physiological Effects of Drugs; Psychotropic Drugs; Hallucinogens; Psilocybin
• Other Study ID Numbers: CLA PSY 201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No