Trial of Tirzepatide for the Treatment of Cannabis Use Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tirzepatide, Placebo.
- Who it may be relevant to
- Registry conditions: Cannabis Use Disorder. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized, Double-Blind, Placebo-Controlled Pilot Trial of Tirzepatide for Treatment of Cannabis Use Disorder (CUD)
Overview
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.
Detailed 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.
Interventions
- Drug Tirzepatide
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. - Drug Placebo
Participants will receive weekly masked injections of placebo.
Primary outcome measures
- Maximum Tolerated Dose (MTD) [Time frame: 24 weeks (Treatment Phase)]
- Days of Abstinence [Time frame: 24 weeks (Treatment Phase)]
Secondary outcome measures (6)
- Severity of Cannabis Use Disorder (CUD) [Time frame: 24 weeks (Treatment Phase)]
- Negative Urine Drug Screens (UDS) [Time frame: 24 weeks (Treatment Phase)]
- Cannabis Craving [Time frame: 24 weeks (Treatment Phase)]
- 1. Cannabis Withdrawal [Time frame: 24 weeks (Treatment Phase)]
- Retention in Treatment [Time frame: Week 24 (End of Treatment Phase)]
- Quality of Life [Time frame: 24 weeks (Treatment Phase)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07468552 · NIDA/VA CS #1037