Clinical Trial

Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder

Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to determine the safety and efficacy of psilocybin assisted Therapy (PAT) in individuals with comorbid Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD). The main question it aims to answer is: \- What is the feasibility and safety of administering PAT in adults with MDD-AUD by evaluating recruitment, retention, tolerability, and safety? Researchers will compare the psilocybin (25 mg) and placebo groups to see if there are any significant differences in frequency of dropouts or serious adverse events. Participants will: * be randomized to receive either psilocybin (25 mg) or placebo * visit the site (in-person and remotely) for a total of 14 times to complete study tasks * receive psilocybin-assisted therapy (PAT) at five various timepoints
Trial Details
NCT Number NCT07405606
Lead Sponsor Centre for Addiction and Mental Health
Conditions Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
Enrollment 30 participants
Start Date 2026-03
Primary Completion 2028-03 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-02-12