Tirzepatide for the Treatment of Cannabis Use Disorder

Mass General Brigham

Status and phase: Begins enrollment in 4 months; Phase 2

Conditions: Cannabis Use Disorder

Treatments: Drug: Tirzepatide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07265752

2025P002984

Details and patient eligibility

About

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

Full description

This is a pilot randomized cross-over trial to examine the effects of tirzepatide on cue-reactivity among individuals with cannabis use disorder. Eligible participants will be scheduled in random order to receive either tirzepatide or placebo injection in double-blind fashion and cross-over design. Outcomes will be assessed at the following study visit. Washout period of at least 4 weeks will be required between tirzepatide or placebo injections. Primary outcome of interest is cue-induced craving to cannabis-related visual cues.

Enrollment: 6 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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
• History of hypersensitivity or allergy to tirzepatide
• Pregnant or breastfeeding
• Individuals taking glucagon-like peptide-1 agonists or other weight loss drugs.
• Anticipated to participate in a concurrent drug trial
• Any other reason or clinical condition that the investigators judge may interfere with study participation and/or be unsafe for a participant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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6 participants in 2 patient groups, including a placebo group

tirzepatide

Experimental group

Description:

2.5mg subcutaneous injection once

Treatment:

Drug: Tirzepatide

placebo

Placebo Comparator group

Description:

matching placebo subcutaneous injection once

Treatment:

Drug: Placebo