Trial of Tirzepatide for the Treatment of Cannabis Use Disorder

National Institutes of Health (NIH)

Status and phase

Begins enrollment in 6 months

Phase 2

Conditions

Cannabis Use Disorder

Treatments

Drug: Placebo

Drug: Tirzepatide

Study type

Interventional

Funder types

NIH

Identifiers

NCT07468552

NIDA/VA CS #1037

Details and patient eligibility

About

The purpose of this randomized, double-blind, placebo-controlled, multi-site clinical trial is to evaluate the safety and efficacy of tirzepatide in a sample of 100 patients diagnosed with moderate or severe CUD by DSM-5 criteria.

Full description

This is a double-blind, placebo-controlled, randomized clinical trial. 100 individuals with moderate to severe cannabis use disorder (CUD) will be randomized in a 1:1 ratio to receive either (1) weekly subcutaneous injections of tirzepatide or (2) weekly subcutaneous injections of matching placebo for 24 weeks. Tirzepatide will be initiated at 2.5 mg for 4 weeks (4 injections) and increased in 2.5 mg increments every 4 weeks as tolerated, up to a maximum dose of 15 mg.

The Primary Objective is to determine the maximum tolerated dose (MTD) of tirzepatide in individuals with CUD and to evaluate its efficacy in reducing cannabis use.

The primary Hypothesis is that tirzepatide will be well tolerated within the FDA-recommended dose range and compared with placebo, it will result in a significantly greater proportion of cannabis abstinent days as measured by the timeline follow-back (TLFB).

Secondary Objectives are to evaluate the effects of tirzepatide, relative to placebo, on (1) CUD severity based on DSM-5 criteria; (2) percentage of cannabis-negative weekly urine drug screens collected during the treatment period; (3) cannabis craving; (4) cannabis withdrawal severity; (5) retention in treatment; and (6) quality of life.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Between 18 and 70 years of age
Meets DSM-5 criteria for moderate or severe CUD
Interested in treatment for cannabis use disorder
Able to understand the study procedures and written informed consent in English
Willing to comply with all study procedures and medication instructions
If female, is not pregnant, and agrees to use acceptable birth control methods

Exclusion criteria

Body Mass Index (BMI) ≤ 23 kg/m²
Presence of a medical or psychiatric disorder that contraindicates participation in the study
Substance use disorder other than tobacco or mild alcohol-use disorder
Known allergy or hypersensitivity to Tirzepatide, any GLP-1 or GIP receptor agonist, or any of the excipients in the product
Current or recent (past 30 days) use of GLP-1 receptor agonists or other weight-loss drug
Current or recent (past 6 months) enrollment in substance use disorder treatment
Current or planned pregnancy and breastfeeding
Living or medical situation that would interfere with adherence to the study protocol