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

Psilocybin

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.

Intervention / Treatment

  • Psilocybin (DRUG)
    Psilocybin and psychotherapy
  • Placebo (DRUG)
    Placebo and psychotherapy

Condition or Disease

  • Alcohol Use Disorder

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Recruiting
    Study results: No Results Available
    Age: 18 Years to 70 Years
    Enrollment: 128 (ESTIMATED)
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Nov 02, 2022 ACTUAL
    Primary Completion: Sep 01, 2023 ESTIMATED
    Completion Date: Feb 01, 2024 ESTIMATED
    Study First Posted: Dec 12, 2022 ACTUAL
    Last Updated: Sep 08, 2023

    Sponsors / Collaborators

    Lead Sponsor: Clairvoyant Therapeutics
    Lead sponsor is responsible party
    Responsible Party: N/A

    Participant Groups

    • 2 oral doses of 25mg psilocybin capsules

    • 2 oral doses of placebo (microcrystalline cellulose) capsules

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 70
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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.

    This clinical trial is recruiting

    Are you interested in participating in this trial or others? We'd love to help.

    Primary Outcomes

    • 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).

    More Details

    NCT Number: NCT05646303
    Other IDs: CLA PSY 201
    Study URL: https://clinicaltrials.gov/study/NCT05646303
    Last updated: Sep 29, 2023