NCT07671248Not yet recruitingPhase 3
Tirzepatide in the Treatment of Cannabis Use Disorder
A 12-Week Phase 3 Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Tirzepatide-Assisted-Psychotherapy in Adults With Cannabis Use Disorder: A Proof-of-Concept Study
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
Cannabis is the most commonly used psychoactive substance in Canada. 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. 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. Tirzepatide acts as both a GLP-1RA and a glucose-dependent insulinotropic polypeptide receptor agonist. Tirzepatide has been reported to reduce alcohol consumption, and therefore may have promising effects as a treatment for 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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 15 Jun 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- McMaster University
- NCT number
- NCT07671248
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 15
- From 1 Aug 2026 to the primary completion date, 31 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Positive urine drug screen for any substance except cannabis
- Concurrent addiction-focused psychotherapy in the past 6 months
- Concomitant treatment with: other GLP-1 agonists, Contrave, bupropion, naltrexone, acamprosate within the past year. No lifetime treatment with tirzepatide.
- Co-enrollment in a clinical drug trial
Other illness
- 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
- 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
Age
- Females who are pregnant/nursing, or individuals in reproductive age who do not consent to using birth control during the study
Other
- Significant literacy, visual, or hearing problems
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MacAnxiety Research Centre Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.