Status:
RECRUITING
Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Johns Hopkins University
University of Maryland
Conditions:
Alcohol Use Disorder
Alcoholism
Eligibility:
All Genders
22-65 years
Phase:
PHASE2
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).
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT05995769
Start Date
March 20 2024
End Date
October 1 2027
Last Update
May 7 2024
Active Locations (1)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6