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

This open-label, single-arm intervention trial (n=16) aims to evaluate the safety, tolerability, and efficacy of psilocybin-assisted psychotherapy in adults with Cannabis Use Disorder (CUD).

Participants will undergo a 9-week treatment protocol consisting of supportive psychotherapy and Motivational Enhancement Therapy, including 8 therapy sessions and 2 experimental drug sessions. The study will assess the incidence of adverse events, the percentage of participants completing the protocol, feasibility, efficacy in reducing cannabis use and associated symptoms, changes in urinary cannabinoids, and severity of craving, withdrawal, anxiety, depression, and functional impairment over the 9-week period.

This trial, sponsored by McMaster University and conducted in collaboration with the Center for Medicinal Cannabis Research, is scheduled to commence in March 2024 and conclude in June 2026.

Trial Details

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 a 9-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.

NCT Number NCT06225232

Data attribution

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