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Psilocybin in the Treatment of Cannabis Use Disorder: A-Proof-of-Concept Study

Study acronym: PSI_CUD
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Mar 2026 → Dec 2026
See other at-risk trials from McMaster University

Record History

  1. Primary completion pushed from Mar 2026 to Dec 2026 Enrollment closed, study ongoing · Completion pushed from Jun 2026 to Dec 2026 · Start date changed from estimate of Mar 2025 to Mar 21, 2025 · 2 morev3 Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Completion pushed from Jun 2026 to Dec 2026
    • Start date changed from estimate of Mar 2025 to Mar 21, 2025
    • Site details revised
    • Collaborators: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Start date: Mar 2024 to Mar 2025 · Study sites: 0 to 1 · Eligibility criteria expanded, about 10 words · 1 morev2 Show 4 more changesShow less
    • Start date: Mar 2024 to Mar 2025
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 10 words
    • Collaborators: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cannabis is the most commonly used psychoactive substance in Canada (Lowry \& Corsi, 2020). A sub-group of cannabis users develop a condition known as Cannabis Use Disorder (CUD), which is defined as a regular pattern of cannabis use that causes performance difficulty at work, school and relationships (Hasin et al., 2013). A review of current treatments available for CUD indicate the lack of a pharmacological and psychological treatment with high success rates, which highlights the importance of exploring potential psychosocial interventions for the treatment of CUD. Given the evidence of psilocybin's therapeutic potential in the treatment of substance use disorders (de Veen et al., 2017), we aim to conduct a study using psilocybin-assisted-psychotherapy in the treatment of CUD. The study aims to evaluate the feasibility, safety, tolerability and potential therapeutic effect of 2 doses \[25 mg\] of psilocybin administered as part of an 8-week Motivational Enhancement Therapy (MET) and supportive therapy. This trial will be the first to evaluate the potential treatment effects of psilocybin on symptoms of CUD.
Trial Details
NCT Number NCT06225232
Lead Sponsor McMaster University
Collaborators: Michael G. DeGroote Centre for Medicinal Cannabis Research
Conditions Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov