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PAP-AUD: Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder

Sponsor
University of Calgary (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05995769
Collaborator
Johns Hopkins University (Other), University of Maryland (Other), Canadian Institutes of Health Research (CIHR) (Other), Bloom Psychedelic Therapy and Research Institute (Other)
128
Enrollment
2
Arms
43
Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Mechanisms Supporting Psilocybin-assisted Psychotherapy for Alcohol Use Disorder: A Randomized, Controlled Clinical Trial
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
May 1, 2027
Anticipated Study Completion Date :
May 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: High Dose (25mg)

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

Drug: Psilocybin
Single dosing session followed by 5 MET weekly sessions starting 24hrs after dosing
Other Names:
  • magic mushrooms
  • PEX010

    		•
    Active Comparator: Low dose (1mg)

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

    Drug: Psilocybin
    Single dosing session followed by 5 MET weekly sessions starting 24hrs after dosing
    Other Names:
  • magic mushrooms
  • PEX010

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Heavy drinking [Change from baseline to 1-, 4-, and 12-weeks post-dosing]

      Percent heavy drinking days (TLFB)

    Secondary Outcome Measures

    1. Abstinence [Change from baseline to 1-, 4-, and 12-weeks post-dosing]

      Days abstinent (TLFB)

    2. Biomarkers of alcohol consumption [Change from baseline to 1-, 4-, and 12-weeks post-dosing]

      Phosphatidylethanol (Peth)

    3. Alcohol cue reactivity [Change from baseline to 1-, 4-, and 12-weeks post-dosing]

      Alcohol urge questionnaire (AUQ)

    4. Cognitive flexibility [Change from baseline to 1-, 4-, and 12-weeks post-dosing]

      Berg Card Sorting Task

    5. Depression [Change from baseline to 1-, 4-, and 12-weeks post-dosing]

      The Montgomery-Åsberg Depression Rating Scale (MADRS)

    6. Anxiety [Change from baseline to 1-, 4-, and 12-weeks post-dosing]

      The General Anxiety Disorder 7 (GAD-7) scale

    7. Quality of life [Change from baseline to 1-, 4-, and 12-weeks post-dosing]

      The World Health Organization Quality of Life (WHOQOL) scale

    8. Glutamate levels [Change from baseline to 1-week post-dosing]

      MR spectroscopy of glutamate levels in the anterior cingulate cortex

    9. GABA levels [Change from baseline to 1-week post-dosing]

      MR spectroscopy of GABA levels in the anterior cingulate cortex

    10. Resting state functional connectivity [Change from baseline to 1-week post-dosing]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Calgary
    • Johns Hopkins University
    • University of Maryland
    • Canadian Institutes of Health Research (CIHR)
    • Bloom Psychedelic Therapy and Research Institute

    Investigators

    • Principal Investigator: Leah Mayo, PhD, University of Calgary

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Calgary
    ClinicalTrials.gov Identifier:
    NCT05995769
    Other Study ID Numbers:
    • REB23-0666
    First Posted:
    Aug 16, 2023
    Last Update Posted:
    Aug 22, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Alcoholism
    Alcohol Drinking
    Psilocybin

    Study Results

    No Results Posted as of Aug 22, 2023