Tirzepatide in the Treatment of Cannabis Use Disorder

NCT07671248 | Not Yet Recruiting Phase 3

• 1 other identifier: Tirzep_CUD
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cannabis Use Disorder, Moderate; Cannabis Use Disorder, Severe

Keywords

Cannabis Use Disorder; Motivational Enhancement Therapy; Tirzepatide

Outcome Measures

Primary Outcomes (2)

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

  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.

  From baseline to 12-week endpoint.

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

  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.

  From baseline to 12-week endpoint.

Secondary Outcomes (4)

• Frequency and amount of cannabis use

  From baseline to 12-week endpoint.

• Severity of Cannabis Use Disorder symptoms

  From baseline to 12-week endpoint

• Cannabis cravings

  From baseline to 12-week endpoint

• Cannabis withdrawal symptoms

  From baseline to 12-week endpoint

Other Outcomes (6)

• Change from baseline on the severity of anxiety symptoms

  From baseline to 12-week endpoint

• Change from baseline on Attention Deficit Hyperactivity Disorder symptom severity

  From baseline to 12-week endpoint

• Change from baseline in depression symptoms

  From baseline to 12-week endpoint.

Study Arms (1)

Single Arm

EXPERIMENTAL

This is an open-label single arm intervention. All participants will be offered both Tirzepatide and psychotherapy over the 12-week treatment period.

Drug: Tirzepatide

Interventions

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).

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 and above
• DSM-5 Cannabis Use Disorder diagnosis of at least moderate severity (4+ DSM-5 symptoms)
• or more days of cannabis use per week
• Treatment seeking
• A Body Mass Index (BMI) ≥ 22

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

MacAnxiety Research Centre

Hamilton, Ontario, L8S 1B8, Canada

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Central Study Contacts

Beth Patterson

CONTACT

905-921-7644; bpatter@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 26, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

CA (1)