Trial of Tirzepatide for the Treatment of Cannabis Use Disorder

Sponsor
National Institute on Drug Abuse (NIDA)
Study ID
NCT07468552
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Cannabis Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Nov 15, 2026
Status verified
Mar 2026
Primary completion
Mar 15, 2028
Completion
Nov 15, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Treatment
  • Placebo Comparator: Placebo

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: 24 weeks (Treatment Phase) ]

Central Contacts

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