Actively Recruiting
Psilocybin in the Treatment of Cannabis Use Disorder: A-Proof-of-Concept Study
Led by McMaster University · Updated on 2025-03-19
16
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
Sponsors
M
McMaster University
Lead Sponsor
C
Center for Medicinal Cannabis Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Psilocybin in the Treatment of Cannabis Use Disorder: A-Proof-of-Concept Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form.
- Able to show proof of identity.
- Fluent in English for speaking and reading, able to complete assessments.
- Age between 18 and 65 years.
- Diagnosed with at least moderate Cannabis Use Disorder.
- Desire to reduce or stop cannabis use.
- Medically healthy based on blood tests, liver and kidney function tests, ECG, and physician review.
- Stable living situation for the study duration.
- Willing to follow study rules and procedures.
- Agree to regular medical check-ins and reporting of any side effects.
- If female of childbearing potential, agree to use effective birth control methods during the study.
- If male, agree to use condoms with spermicide and ensure partner uses effective contraception.
- Agree to have a companion accompany and stay with the participant overnight after dosing sessions.
You will not qualify if you...
- History of bipolar disorder, schizophrenia, psychotic disorders, personality disorders, delirium, dementia, or cognitive disorders.
- First-degree relatives with schizophrenia, bipolar disorder, or psychosis.
- Diagnosis of panic disorder or seizure disorders.
- Dependence on substances other than cannabis or tobacco in the past 6 months.
- Positive drug screen for substances other than cannabis.
- Use of serotonergic psychedelics more than 5 times lifetime or in the past year.
- Current use of psychotropic medications except stable doses of SSRIs or SNRIs.
- History of cardiovascular disease, uncontrolled hypertension, or other risky medical conditions.
- Receiving psychotherapy for Cannabis Use Disorder concurrently.
- Serious suicide or homicide risk or recent suicidal behaviors.
- Positive pregnancy test, pregnant, breastfeeding, or not using birth control if of childbearing potential.
- Unable to understand study risks and benefits or give informed consent.
- Participating or planning to participate in other interventional clinical trials during this study.
AI-Screening
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Trial Site Locations
Total: 1 location
1
MacAnxiety Research Centre
Hamilton, Ontario, Canada, L8S 1B8
Actively Recruiting
Research Team
M
Maryam Rahat, Ph.D Candiate
CONTACT
B
Beth Patterson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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