RecruitingPhase 2NCT06225232

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

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


Sponsor

McMaster University

Enrollment

16 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether psilocybin — a compound found in certain mushrooms — can help people reduce or stop cannabis use in those with moderate to severe cannabis use disorder (CUD). This is a proof-of-concept study to see if the approach is feasible and promising enough to test further. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with at least moderate cannabis use disorder - You want to reduce or stop your cannabis use - You are in good general medical health - You have a stable residence and can commit to the full study period - You are fluent in English **You may NOT be eligible if...** - You have a personal or close family history of schizophrenia, bipolar disorder, or other psychotic disorders - You have a history of panic disorder or seizure disorders - You are dependent on any substance other than cannabis or tobacco - You have used psychedelic drugs (LSD, psilocybin, ayahuasca, etc.) more than 5 times in your life or in the past year - You are taking antipsychotic medications, benzodiazepines, or tricyclic antidepressants - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPsilocybin 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

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NCT06225232


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