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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05646303
Recruitment Status : Recruiting
First Posted : December 12, 2022
Last Update Posted : November 3, 2023
Sponsor:
Collaborator:
Optimapharm
Information provided by (Responsible Party):
Clairvoyant Therapeutics

Study Description
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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.


Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Drug: Psilocybin Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 2, 2022
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05646303


Contacts
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Contact: Teresa Yan hello@clairvoyantrx.com

Locations
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Canada, Alberta
Sabi Mind Recruiting
Calgary, Alberta, Canada, T3C 0J7
Contact: Phillippe Lucas       philippe@sabimind.com   
Canada, British Columbia
Okanagan Clinical Trials Recruiting
Kelowna, British Columbia, Canada
Contact: Ethan Klukas, B.A.    250-862-8141    ethan@oktrials.ca   
Centre for Neurology Studies Recruiting
Surrey, British Columbia, Canada
Contact       CNSNeuroStudies@gmail.com   
University of British Columbia, Department of Psychiatry, BRAIN Lab Recruiting
Vancouver, British Columbia, Canada, V6T 1Z3
Contact       brainlab.clairvoyant@ubc.ca   
Principal Investigator: Christian Schutz, MD, PhD, MPH         
Canada, Nova Scotia
Centricity Research Recruiting
Halifax, Nova Scotia, Canada, B3S 1N2
Contact: Heather Rushton       studies@centricityresearch.com   
Canada, Ontario
MacAnxiety Research Centre Recruiting
Hamilton, Ontario, Canada, L8S 1B7
Contact: Beth Patterson    289 396 4242    bpatter@mcmaster.ca   
Department of Psychiatry, Queen's University Recruiting
Kingston, Ontario, Canada
Contact: Claudio Soares, MD, PhD, MBA       Claudio.Soares@kingstonhsc.ca   
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M6J 1H4
Contact: Dea Gjomema    416-979-6933    Dea.Gjomema@camh.ca   
Finland
Research Center Oxidi Oy / Addiktum Oy Recruiting
Helsinki, Finland
Contact: Hannu Alho, MD, PhD         
A-Klinikka Recruiting
Kouvola, Finland, 45100
Contact: Jani Kajanoja         
Mentacare Oy Recruiting
Oulu, Finland
Contact: Markku Timonen         
Addiktum Oy Recruiting
Turku, Finland
Contact: Antti Mikkonen         
Sponsors and Collaborators
Clairvoyant Therapeutics
Optimapharm
Investigators
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Principal Investigator: Hannu Alho, MD Addiktum Oy
More Information
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Responsible Party: Clairvoyant Therapeutics
ClinicalTrials.gov Identifier: NCT05646303    
Other Study ID Numbers: CLA PSY 201
First Posted: December 12, 2022    Key Record Dates
Last Update Posted: November 3, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
 Mental Disorders
Psilocybin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs