Tirzepatide for the Treatment of Cannabis Use Disorder | NCT07265752

Studies
Tirzepatide for the Treatment of Cannabis Use Disorder

NCT07265752

Sponsor

Brigham and Women's Hospital

Status

Not yet recruiting

Last Update Posted

Dec 18, 2025Actual

Enrollment

6Estimated

Phase

Phase 2

Conditions

Cannabis Use Disorder

Interventions

Tirzepatide
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Jun 30, 2028Estimated

Completion Date

Jun 30, 2028Estimated

First Submitted Date

Nov 25, 2025

First Submission Date that Met QC Criteria

Nov 25, 2025

First Posted Date

Dec 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2025

Last Update Posted Date

Dec 18, 2025Actual

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tirzepatide	Experimental	2.5mg subcutaneous injection once	Drug: Tirzepatide
placebo	Placebo Comparator	matching placebo subcutaneous injection once	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tirzepatide	Drug	2.5mg subcutaneous injection once	tirzepatide
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Serious adverse event	Incidence of serious adverse events	5 weeks
Cravings	Cannabis craving scale using the 12-item questionnaire, each item scored on a 1-7 sale. Higher scores (either average or summed) indicates stronger cravings.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000067757	Glucagon-Like Peptide-1 Receptor
D000067756	Glucagon-Like Peptide Receptors
D043562	Receptors, G-Protein-Coupled
D011956	Receptors, Cell Surface