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Not Yet Recruiting
NCT07468552
Trial of Tirzepatide for the Treatment of Cannabis Use Disorder
Conditions: Cannabis Use Disorder
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 100
Sponsor: National Institute on Drug Abuse (NIDA)
Summary
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.
Eligibility 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
Source: ClinicalTrials.gov (NCT07468552). StuddyBuddy aggregates publicly available trial information.