Psilocybin Therapy for Alcoholism
(PAP-AUD Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug psilocybin for treating alcoholism?
Research shows that psilocybin has been studied in clinical trials for various psychiatric disorders, including substance use disorders, and has shown promise with marked, long-term improvements in some patients. It is well tolerated with limited side effects, suggesting potential effectiveness for treating alcoholism.12345
Is psilocybin generally safe for human use?
How is psilocybin therapy different from other treatments for alcoholism?
Psilocybin therapy is unique because it involves the use of a psychedelic compound found in certain mushrooms, which can lead to significant improvements in alcohol dependence after just one or two sessions. Unlike traditional treatments, psilocybin works by affecting serotonin receptors in the brain, potentially offering long-term benefits with minimal side effects.1491011
What is the purpose of this trial?
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).
Research Team
Leah Mayo, PhD
Principal Investigator
University of Calgary
Eligibility Criteria
This trial is for adults who want to cut down on heavy drinking, meet the criteria for a moderate or severe alcohol use disorder, and have had multiple heavy drinking days recently. They should not be frequent users of hallucinogens, pregnant, or trying to become pregnant. People with certain mental health conditions or serious substance abuse issues other than alcohol are not eligible.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete clinical, behavioral, and neuroimaging measures
Treatment
Single dose of psilocybin administered followed by 5 weekly MET sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Psilocybin
Psilocybin is already approved in United States, European Union for the following indications:
- Treatment-resistant depression (TRD) under Breakthrough Therapy designation
- Treatment-resistant depression (TRD) under PRIME designation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
University of Maryland
Collaborator
Johns Hopkins University
Collaborator
Bloom Psychedelic Therapy and Research Institute
Collaborator