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Recruiting Phase 2 NCT05995769

Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder

Trial Parameters

Condition Alcohol Use Disorder
Sponsor University of Calgary
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 128
Sex ALL
Min Age 22 Years
Max Age 65 Years
Start Date 2024-03-20
Completion 2027-10-01
Interventions
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).

Eligibility Criteria

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

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