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

NCT07405606 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Centre for Addiction and Mental Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-03-31
Completion
2028-06-30

Countries

  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07405606 on ClinicalTrials.gov