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RECRUITING
NCT06225232
PHASE2

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

Sponsor: McMaster University

View on ClinicalTrials.gov

Summary

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.

Official title: An 8-week Phase 2 Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Psilocybin-assisted-psychotherapy in Adults With Cannabis Use Disorder: A Proof-of-Concept Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2025-03

Completion Date

2026-06

Last Updated

2025-03-19

Healthy Volunteers

No

Interventions

DRUG

Psilocybin combined with Psychotherapy

The intervention consists of a 9-week treatment protocol that is based on supportive psychotherapy and Motivational Enhancement Therapy. Overall, the therapy course includes 8 motivational enhancement therapy sessions and two experimental drug sessions.

Locations (1)

MacAnxiety Research Centre

Hamilton, Ontario, Canada