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Tirzepatide for the Treatment of Cannabis Use Disorder

NCT ID: NCT07265752

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-07-01

Study Completion Date

2028-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cannabis Use Disorder

Keywords

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tirzepatide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double-blind placebo-controlled

Study Groups

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tirzepatide

2.5mg subcutaneous injection once

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

2.5mg subcutaneous injection once

placebo

matching placebo subcutaneous injection once

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline placebo subcutaneous injection once

Interventions

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Tirzepatide

2.5mg subcutaneous injection once

Intervention Type DRUG

Placebo

Saline placebo subcutaneous injection once

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joji Suzuki, MD

Principal Investigator, Division of Addiction Treatment and Prevention, AMC Psychiatry Mass General Brigham

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joji Suzuki

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Central Contacts

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Mary R Shen, MD

Role: CONTACT

Phone: 6177325752

Email: [email protected]

Other Identifiers

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2025P002984

Identifier Type: -

Identifier Source: org_study_id