Not 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

Lead sponsor

McMaster University

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

Study population

Eligibility highlights

•BMI ≥22

Primary endpoints

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

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07671248

Org study IDTirzep_CUD

Timeline

Milestones

Study first posted2026-06-26actual

Last update posted2026-07-01actual

Study start2026-08-01estimated

Primary completion2028-07-31estimated

Study completion2028-07-31estimated

Assets

Investigational agents

Tirzepatide

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Patient-reported / QoL

Safety / tolerability / PK

Other clinical outcomes

Patient-reported / QoL

1 endpoint

Other/protocol endpoint

Change in baseline quality of life

Time frame:From baseline to 12-point endpoint.

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

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

Time frame:From baseline to 12-week endpoint.

descriptive

Other clinical outcomes

1 endpoint

Primary/protocol endpoint

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

Time frame:From baseline to 12-week endpoint.

descriptive

Other (unclassified)

9 endpoints

Secondary/protocol endpoint/low confidence

Frequency and amount of cannabis use

Time frame:From baseline to 12-week endpoint.

descriptive

Secondary/protocol endpoint/low confidence

Severity of Cannabis Use Disorder symptoms

Time frame:From baseline to 12-week endpoint

descriptive

Secondary/protocol endpoint/low confidence

Cannabis cravings

Time frame:From baseline to 12-week endpoint

descriptive

Secondary/protocol endpoint/low confidence

Cannabis withdrawal symptoms

Time frame:From baseline to 12-week endpoint

descriptive

Other/protocol endpoint/low confidence

Change from baseline on the severity of anxiety symptoms

Time frame:From baseline to 12-week endpoint

change from baseline, improvement

Other/protocol endpoint/low confidence

Change from baseline on Attention Deficit Hyperactivity Disorder symptom severity

Time frame:From baseline to 12-week endpoint

change from baseline, improvement

Other/protocol endpoint/low confidence

Change from baseline in depression symptoms

Time frame:From baseline to 12-week endpoint.

change from baseline, improvement

Other/protocol endpoint/low confidence

Change from baseline in functional impairment

Time frame:From baseline to 12-week endpoint.

change from baseline, improvement

Other/protocol endpoint/low confidence

Change from baseline in OCD symptoms

Time frame:From baseline to 12-week endpoint.

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.