Clinical trial

Trial of Tirzepatide for the Treatment of Cannabis Use Disorder

Opening soon · Phase 2 · 0 countries · Registry ID NCT07468552

Opening soonPhase 2Interventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionCannabis Use Disorder

Full registry criteria

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

Treatments and study arms

Tirzepatide

Drug

Participants will receive weekly injections of tirzepatide 2.5 mg for 4 weeks. The dose is expected to increase by 2.5 mg every 4 weeks, however, the decision to increase the dose will be made based on the Dose Increase Checklist and shared decision between the site study physician (MD or DO) and the participant.

Placebo

Drug

Participants will receive weekly masked injections of placebo.

Primary outcomes

Maximum Tolerated Dose (MTD)24 weeks (Treatment Phase)

The maximum tolerated dose defined as the median dose within the FDA-recommended range, at which dose increase is not recommended (based on standardized and health care provider assessments).

Days of Abstinence24 weeks (Treatment Phase)

Number of days per week with no cannabis use, as assessed by Timeline Follow Back (TLFB).

Study locations

0 locations were listed when this page was built. The first 40 are shown.

No public site location was included in this record. Check the original registry for updates.