Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder

Psilocybin

Brief Summary

The aim of this study is to determine if a single dose of psilocybin administered with motivational enhancement therapy (MET) can reduce heavy drinking in patients with an alcohol use disorder (AUD).

Intervention / Treatment

  • Psilocybin (DRUG)
    Single dosing session followed by 5 MET weekly sessions starting 24hrs after dosing

Condition or Disease

  • Alcohol Use Disorder
  • Alcoholism

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Not yet recruiting
    Study results: No Results Available
    Age: 22 Years to 65 Years
    Enrollment: 128 (ESTIMATED)
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

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

    Clinical Trial Dates

    Start date: Oct 01, 2023 ESTIMATED
    Primary Completion: May 01, 2027 ESTIMATED
    Completion Date: May 01, 2027 ESTIMATED
    Study First Posted: Aug 16, 2023 ACTUAL
    Last Updated: Sep 18, 2023

    Sponsors / Collaborators

    Lead Sponsor: University of Calgary
    Lead sponsor is responsible party
    Responsible Party: N/A

    The primary objective of this study is to determine if psilocybin administered with a standardized psychotherapeutic intervention, motivational enhancement therapy (MET), can reduce heavy drinking in a patient population with an alcohol use disorder (AUD). Patients with an AUD will be randomly allocated to either a high dose (25mg; active treatment) or a low dose (1mg; active control) psilocybin arm. All participants will receive 5 sessions of MET, starting at 24hrs post-dosing. Heavy drinking will be assessed as percent heavy drinking days using the Time Line Follow Back (TLFB) at baseline and 1-, 4-, and 12-weeks post-dosing.

    A total of 128 male and female patients between the ages of 22-65 with a moderate to severe AUD diagnosis will be recruited from the community. Participants will undergo a thorough screening procedure and eligible participants will be randomly allocated to the high (N=64) or low (N=64) psilocybin doses. All participants will complete a baseline session consisting of clinical, behavioral, and neuroimaging measures. Following the single dosing session, participants will complete 5 weekly MET sessions. Neuroimaging measures will be assessed again at 1-week post-doing. Clinical and behavioral outcomes will be measured at 1-, 4-, and 12-weeks post-dosing

    Participant Groups

    • PEX010 (Oral Psilocybin), 25mg; single dose administered 24hrs prior to first of 5 weekly MET sessions

    • PEX010 (Oral Psilocybin), 1mg; single dose administered 24hrs prior to first of 5 weekly MET sessions

    Eligibility Criteria

    Sex: All
    Minimum Age: 22
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Meets DSM-5 AUD criteria of at least moderate severity
    * At least 5 heavy drinking days in past 30 days
    * At least 18 (females) or 24 (males) drinks per week in past 30 days
    * Desire to decrease alcohol consumption
    * Limited lifetime hallucinogen use (less than 10 times total, none in past 6 months)

    Exclusion Criteria:

    * Severe or moderate substance use disorder other than alcohol or nicotine in past 6 months
    * Diagnosis of schizophrenia, bipolar disorders or first-degree relative with diagnosis
    * Active suicidal ideation or serious attempt within past 3 years
    * Currently pregnant, nursing, or trying to become pregnant
    * Any notable abnormality on ECG, physical exam, or routine medical blood laboratory test

    Primary Outcomes

    • Percent heavy drinking days (TLFB)

    Secondary Outcomes

    • Days abstinent (TLFB)

    • Phosphatidylethanol (Peth)

    • Alcohol urge questionnaire (AUQ)

    • Berg Card Sorting Task

    • The Montgomery-Åsberg Depression Rating Scale (MADRS)

    • The General Anxiety Disorder 7 (GAD-7) scale

    • The World Health Organization Quality of Life (WHOQOL) scale

    • MR spectroscopy of glutamate levels in the anterior cingulate cortex

    • MR spectroscopy of GABA levels in the anterior cingulate cortex

    • Resting state functional connectivity Change from baseline to 1-week post-dosing

    More Details

    NCT Number: NCT05995769
    Other IDs: REB23-0666
    Study URL: https://clinicaltrials.gov/study/NCT05995769
    Last updated: Sep 29, 2023