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

November 1, 2023 updated by: Clairvoyant Therapeutics

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3C 0J7
    • British Columbia
      • Kelowna, British Columbia, Canada
        • Recruiting
        • Okanagan Clinical Trials
        • Contact:
      • Surrey, British Columbia, Canada
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • Recruiting
        • University of British Columbia, Department of Psychiatry, BRAIN Lab
        • Principal Investigator:
          • Christian Schutz, MD, PhD, MPH
        • Contact:
    • Nova Scotia
    • Ontario
      • Hamilton, Ontario, Canada, L8S 1B7
        • Recruiting
        • MacAnxiety Research Centre
        • Contact:
      • Kingston, Ontario, Canada
      • Toronto, Ontario, Canada, M6J 1H4
        • Recruiting
        • Centre for Addiction and Mental Health
        • Contact:
  • Finland
      • Helsinki, Finland
        • Recruiting
        • Research Center Oxidi Oy / Addiktum Oy
        • Contact:
          • Hannu Alho, MD, PhD
      • Kouvola, Finland, 45100
        • Recruiting
        • A-Klinikka
        • Contact:
          • Jani Kajanoja
      • Oulu, Finland
        • Recruiting
        • Mentacare Oy
        • Contact:
          • Markku Timonen
      • Turku, Finland
        • Recruiting
        • Addiktum Oy
        • Contact:
          • Antti Mikkonen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clairvoyant Therapeutics

Collaborators

Optimapharm

Investigators

  • Principal Investigator: Hannu Alho, MD, Addiktum Oy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2022

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

October 1, 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 (Estimated)

November 3, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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