Trial of Tirzepatide for the Treatment of Cannabis Use Disorder

NCT07468552 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: NIDA/VA CS #1037
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cannabis Use Disorder

Keywords

Cannabis Use; Cannabis Addiction; Marijuana Addiction

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose (MTD)

  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).

  24 weeks (Treatment Phase)

• Days of Abstinence

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

  24 weeks (Treatment Phase)

Secondary Outcomes (6)

• Severity of Cannabis Use Disorder (CUD)

  24 weeks (Treatment Phase)

• Negative Urine Drug Screens (UDS)

  24 weeks (Treatment Phase)

• Cannabis Craving

  24 weeks (Treatment Phase)

• 1. Cannabis Withdrawal

  24 weeks (Treatment Phase)

• Retention in Treatment

  Week 24 (End of Treatment Phase)

Study Arms (2)

Active Treatment

EXPERIMENTAL

Drug: Tirzepatide

Placebo

PLACEBO COMPARATOR

Drug: Placebo

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.

Active Treatment

Placebo DRUG

Participants will receive weekly masked injections of placebo.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Jia Bei Wang, MD, PhD

  NIDA/NIH, Division of Therapeutics and Medical Consequences (DTMC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Wong, PhD

CONTACT

301-827-6267; Jennifer.Wong3@nih.gov

Jana Drgonova, PhD

CONTACT

301-827-5933; jana.drgonova@nih.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Model Details: A parallel, randomized trial with 1:1 assignment to treatment versus placebo. The starting dose of active the medication (tirzepatide) is 2.5 mg, and is expected to increase by 2.5 mg every 4 weeks based on its tolerability and participant's adherence

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 12, 2026
• Study Start (Estimated): November 15, 2026
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): November 15, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03