RecruitingPhase 2NCT05995769
Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder
Mechanisms Supporting Psilocybin-assisted Psychotherapy for Alcohol Use Disorder: A Randomized, Controlled Clinical Trial
Sponsor
University of Calgary
Enrollment
128 participants
Start Date
Mar 20, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 22 YearsMax Age: 65 Years
Inclusion Criteria4
- 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 Criteria5
- 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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Interventions
DRUGPsilocybin
Single dosing session followed by 5 MET weekly sessions starting 24hrs after dosing
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05995769
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