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Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 26, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07405606). This is a study registration, not published results. Lead sponsor: Centre for Addiction and Mental Health. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD). Interventions: DRUG: Psilocybin 25 mg; DRUG: Placebo. Primary outcome measures: Adherence , Week 2 (Visit 4); Montgomery-Asberg Depression Rating Scale (MADRS) , Baseline; 1-day post dose; 1-week post dose; 2-week post dose; 3-week post dose; 4-week post dose; week 10; week 14; week 18; week 22; week 26.; Hamilton Depression Rating Scale (HAMD-17) , 4-week post dose; week 26.; Quick Inventory of Depressive Symptomatology - Self Report (QUIDS-SR) , Baseline; 1-day post dose; 1-week post dose; 2-week post dose; 3-week post dose; 4-week post dose; week 10; week 14; week 18; week 22; week 26.; Alcohol Timeline Followback (TLFB) , Baseline; week 2 (visit 3); 1-day post dose; 1-week post dose; 2-week post dose; 3-week post dose; 4-week post dose; week 10; week 14; week 18; week 22; week 26.; Clinical Institute Withdrawal Assessment (CIWA) , Baseline; week 2 (visit 3); week 2 (visit 4); 1-day post dose; 1-week post dose; 2-week post dose; 3-week post dose; 4-week post dose; week 10; week 14; week 18; week 22; week 26.; Prediction of Alcohol Withdrawal Severity Scale (PAWSS) , Baseline; 1-day post dose; 1-week post dose; 2-week post dose; 3-week post dose; 4-week post dose; week 10; week 14; week 18; week 22; week 26.; Penn Alcohol Craving Scale (PACS) , Baseline; 1-day post dose; 1-week post dose; 2-week post dose; 3-week post dose; 4-week post dose; week 10; week 14; week 18; week 22; week 26.; Addiction Severity Index (ASI) , Baseline; 1-day post dose; 1-week post dose; 2-week post dose; 3-week post dose; 4-week post dose; week 10; week 14; week 18; week 22; week 26.. Brief 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