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NCT Number: NCT07671248

Tirzepatide in the Treatment of Cannabis Use Disorder

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.

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Key information

Conditions

Cannabis Use Disorder, Moderate Cannabis Use Disorder, Severe Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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, naltrexone, acamprosate within the past year. No lifetime treatment with tirzepatide.
  • Significant literacy, visual, or hearing problems
  • Co-enrollment in a clinical drug trial

Treatment and study plan

Tirzepatide

Drug

Treatment will occur over a 12-week period, with once-weekly injections of escalating doses every 3 weeks from 2.5mg to 10mg. Tirzepatide will be used in conjunction with Motivational Enhancement Therapy (MET).

Primary outcomes

  1. Tolerability of Tirzepatide-Assisted-Psychotherapy for Cannabis Use Disorder.

    Time frame: From baseline to 12-week endpoint.

    Tolerability will be measured by the percent of participants who discontinue the trial.

    Tolerability will also be measured by the percent of participants who reach the target dose.

  2. Feasibility of Tirzepatide-Assisted-Psychotherapy for Cannabis Use Disorder.

    Time frame: From baseline to 12-week endpoint.

    Feasibility will be evaluated based on the number of people who contact the study team, percent of people that contact who are eligible and percent of eligible participants who enroll.

Secondary outcomes

  1. Frequency and amount of cannabis use

    Time frame: From baseline to 12-week endpoint.

    The Enhanced Cannabis Timeline Follow Back (EC-TLFB) obtains information about frequency of cannabis use, amount used, types of cannabis products, and methods of administration.

  2. Severity of Cannabis Use Disorder symptoms

    Time frame: From baseline to 12-week endpoint

    The Self-Reported Symptoms of Cannabis Use Disorder (SRSCUD) is a 13-item self-report form that allows individuals to rate the severity of their Cannabis Use Disorder on a scale from 1 to 4. Total scores range from 0 to 39, with a higher score indicating greater symptom severity.

  3. Cannabis cravings

    Time frame: From baseline to 12-week endpoint

    The Marijuana Craving Questionnaire - Short Form (MCQ-SF) is a self-report 12-item questionnaire used to assess individual's cannabis craving experiences.

  4. Cannabis withdrawal symptoms

    Time frame: From baseline to 12-week endpoint

    The Marijuana Withdrawal Checklist (MWC) is a self-report 15-item questionnaire used to assess symptoms of cannabis withdrawal. Participants rate items on a Likert scale from 0 (not at all) to 3 (severe) based on their most recent period of cannabis abstinence. Scores range from 0 to 45, with higher scores indicating greater withdrawal symptom severity.

Other outcomes

  1. Change from baseline on the severity of anxiety symptoms

    Time frame: From baseline to 12-week endpoint

    The Generalized Anxiety Disorder-7 (GAD-7) is a self-report 7-item questionnaire that measures anxiety symptom severity. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 21, with higher scores indicating greater symptom severity.

  2. Change from baseline on Attention Deficit Hyperactivity Disorder symptom severity

    Time frame: From baseline to 12-week endpoint

    The Barkley's Adult ADHD Rating Scale - I (BAARS-IV) is a 21 item self-report questionnaire that assesses ADHD symptom severity.

  3. Change from baseline in depression symptoms

    Time frame: From baseline to 12-week endpoint.

    The Patient Health Questionnaire-9 (PHQ-9) is a self-report measure with 9-items used to assess the presence of depression symptoms in the past 2 weeks. Items are scored on a Likert scale from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 27, with higher scores indicating greater depression severity.

  4. Change from baseline in functional impairment

    Time frame: From baseline to 12-week endpoint.

    The Sheehan Disability Scale (SDS) is a self-report scale of functional impairment. Responses are based on an eleven-point scale from 0 (not at all) to 10 (extremely). Total scores range from 0 to 30, with higher scores indicating greater impairment.

  5. Change from baseline in OCD symptoms

    Time frame: From baseline to 12-week endpoint.

    The Obsessive Compulsive Inventory - Revised (OCI-R) is an 18-item self-report questionnaire that assesses various obsessions.

  6. Change in baseline quality of life

    Time frame: From baseline to 12-point endpoint.

    The World Health Organization Quality of Life assessment (WHOQOL-BREF) is a self-report measure that assesses quality of life across physical health, psychological, social relationships, and environment domains. The WHOQOL-BREF consists of 26 items that are rated on a 5-point Likert scale. Scores are transformed to range from 0 to 100, with higher scores indicating better quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Beth Patterson

CONTACT

[email protected]

905-921-7644

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 26, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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