Tirzepatide in the Treatment of Cannabis Use Disorder: A Proof-of-Concept Study (NCT07671248) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Tirzepatide in the Treatment of Cannabis Use Disorder: A Proof-of-Concept Study
Canada15 participantsStarted 2026-08-01
Plain-language summary
Cannabis is the most commonly used psychoactive substance in Canada (Lowry \& Corsi, 2020). A sub-group of cannabis users develop Cannabis Use Disorder (CUD). CUD is a pattern of cannabis use that results in impairment in functioning, symptoms of tolerance, withdrawal, and distress (Hasin et al., 2013). Several pharmacological and psychosocial interventions have been evaluated for their efficacy in treating CUD, however they lack high success rates. GLP-1RA's have shown promising results in reducing food and alcohol cravings and intake (Bruns et al., 2024). Tirzepatide acts as both a GLP-1RA and a glucose-dependent insulinotropic polypeptide receptor agonist (Min \& Bain, 2021). Tirzepatide has been reported to reduce alcohol consumption (Quddos et al., 2023), and therefore may have promising effects as a treatment for CUD. We aim to conduct a study using Tirzepatide-assisted-psychotherapy in the treatment of CUD. This study aims to evaluate the feasibility and tolerability of weekly injections of Tirzepatide combined with Motivational Enhancement Therapy in adults with CUD. This trial will be the first to examine the potential therapeutic effects of Tirzepatide in CUD.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 and above
* DSM-5 Cannabis Use Disorder diagnosis of at least moderate severity (4+ DSM-5 symptoms)
* 4 or more days of cannabis use per week
* Treatment seeking
* A Body Mass Index (BMI) ≥ 22
Exclusion Criteria:
* Meet DSM-5 criteria for Cluster A or B personality disorders and/or unstable current bipolar disorder, schizophrenia, or psychotic disorder
* Comorbid severe DSM-5 Major Depressive Disorder
* Present a serious suicide risk or who are likely to require psychiatric hospitalization during the course of the study, as determined by the study physician and Columbia Suicide Severity Rating Scale
* Any other mental health condition deemed incompatible by the study team
* Meet DSM-5 criteria for alcohol or substance use disorder for any substance other than cannabis or tobacco in the past 6 months
* Positive urine drug screen for any substance except cannabis
* Concurrent addiction-focused psychotherapy in the past 6 months
* Unstable management of an existing mental health condition or anticipation of a change to the treatment over the next 3 months
* A personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2
* Current unstable medical condition
* A lifetime diagnosis of Diabetes
* Females who are pregnant/nursing, or individuals in reproductive age who do not consent to using birth control during the study
* Concomitant treatment with: other GLP-1 agonists, Contrave, bupropion, naltrexon…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tolerability of Tirzepatide-Assisted-Psychotherapy for Cannabis Use Disorder.
Timeframe: From baseline to 12-week endpoint.
2
Feasibility of Tirzepatide-Assisted-Psychotherapy for Cannabis Use Disorder.