Using psilocybin with therapy to help reduce heavy drinking in people with alcohol use disorder
Mechanisms Supporting Psilocybin-assisted Psychotherapy for Alcohol Use Disorder: A Randomized, Controlled Clinical Trial
This study is testing if a single dose of psilocybin, along with therapy, can help people with alcohol use disorder drink less over 12 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 22 Years to 65 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT05995769 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a single dose of psilocybin combined with motivational enhancement therapy (MET) in reducing heavy drinking among individuals diagnosed with alcohol use disorder (AUD). Participants will be randomly assigned to receive either a high dose of psilocybin or a low dose as a control, followed by five sessions of MET. The study will assess changes in heavy drinking days over a 12-week period using the Time Line Follow Back method. A total of 128 participants aged 22-65 will be recruited, and various clinical and neuroimaging measures will be taken to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22-65 with a moderate to severe diagnosis of alcohol use disorder who wish to reduce their alcohol consumption.
Not a fit: Patients with severe substance use disorders other than alcohol, or those with certain psychiatric conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for individuals struggling with alcohol use disorder.
How similar studies have performed: Previous studies have shown promising results with psilocybin in treating various mental health conditions, suggesting potential success for this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Calgary, Alberta
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Leah Mayo, PhD — University of Calgary
- Study coordinator: Kaitlin O'Grady
- Email: pactlab@ucalgary.ca
- Phone: 587-893-0257
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.