NCT07405606

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

Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder: A Pilot Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Major Depressive Disorder (MDD)
• Alcohol Use Disorder (AUD)

Interventions

Type	Name	Description
DRUG	Psilocybin 25 mg	Participants will orally consume Psilocybin (25 mg) with water.
DRUG	Placebo	Participants will orally consume placebo matching the intervention with water.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-03-01
• Completion: 2028-06-01
• First posted: 2026-02-12
• Last updated: 2026-02-12

Locations

1 site across 1 country: Canada