Tirzepatide for the Treatment of Cannabis Use Disorder

NCT07265752 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2025P002984
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a pilot randomized cross-over trial to examine the effects of tirzepatide on cue-reactivity among individuals with cannabis use disorder.

Conditions

Cannabis Use Disorder

Keywords

tirzepatide

Outcome Measures

Primary Outcomes (1)

• Cue-Induced Craving

  Craving scores will be assessed using a cue-reactivity paradigm in which participants are exposed to cannabis\]-related cues. Scores range from 0 to 30, with higher scores indicating greater craving intensity.

  5 weeks

Secondary Outcomes (9)

• Serious adverse event

  5 weeks

• Cravings

  5 weeks

• Abstinence

  5 weeks

• Weight

  5 weeks

• Blood sugar

  5 weeks

Study Arms (2)

tirzepatide

EXPERIMENTAL

2.5mg subcutaneous injection once

Drug: Tirzepatide

placebo

PLACEBO COMPARATOR

matching placebo subcutaneous injection once

Drug: Placebo

Interventions

Tirzepatide DRUG

2.5mg subcutaneous injection once

tirzepatide

Placebo DRUG

Saline placebo subcutaneous injection once

placebo

Eligibility Criteria

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

You may qualify if:

• English speaking adults aged 18 and above
• Diagnosed with DSM-5 cannabis use disorder, severe

You may not qualify if:

• Active psychosis, active suicidality or homicidality or any psychiatric condition that impair ability to provide informed consent
• Any current or lifetime diagnosis of eating disorders including anorexia, bulimia, binge eating or
• Comorbid substance use disorder
• BMI\<21 kg/m2
• Current or lifetime diagnosis of Type 1 or Type 2 diabetes
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
• Use of any glucagon-like peptide -1 agonist medications in the prior 3 months
• Anticipating receipt of any glucagon-like peptide-1 agonist medications during the trial
• Current hypoglycemia as indicated by a blood sugar level of \<71 mg/dL measured at baseline visit, as well as visits 2 and 4.
• Untreated cholelithiasis or gallbladder disease
• History of acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or congestive heart failure in the last 90 days
• Systolic blood pressure persistently above 160 mmHg or diastolic blood pressure persistently above 100 mmHg during screening
• History of inflammatory bowel disease, bariatric surgery, pancreatitis, diabetic gastroparesis, or non-arteritic anterior ischemic optic neuropathy
• Liver function test greater than 3 times upper normal limit
• Renal impairment as indicated by estimated glomerular filtration rate (eGFR) of \<30

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

MeSH Terms

Interventions

Tirzepatide

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

• Joji Suzuki

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary R Shen, MD

CONTACT

6177325752; mshen4@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind placebo-controlled
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Division of Addiction Treatment and Prevention, AMC Psychiatry Mass General Brigham

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 5, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share