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RecruitingPhase 2

Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder

NCT05995769 · PAP-AUD · University of Calgary

Recruiting
Status
Accepting participants
Phase 2
Phase
128
Target enrolment
1
Study sites
Outside the US

What it is testing

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).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Heavy drinking

    Measured over Change from baseline to 1-, 4-, and 12-weeks post-dosing

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

22 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Meets DSM-5 AUD criteria of at least moderate severity * Meets heavy drinking requirements (heavy drinking days, number of drinks) in past 30 days * Desire to decrease alcohol consumption * Limited lifetime hallucinogen use 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

Where

1 study site

FacilityCityRegionCountry
University of CalgaryCalgaryAlbertaCanada

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05995769 on ClinicalTrials.gov →

Last updated in the registry 2024-05-07. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

All 4 trials from University of Calgary →