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Not yet recruitingNCT07265752Updated Sep 24, 2026

Tirzepatide for the Treatment of Cannabis Use Disorder

A Phase 2 interventional study of Tirzepatide and Placebo in Cannabis Use Disorder, sponsored by Brigham and Women's Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Brigham and Women's Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cannabis Use Disorder

Keywords

  • tirzepatide
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
6 participants (estimated)

Study arms

  • Experimental
    tirzepatide

    2.5mg subcutaneous injection once

    Drug: Tirzepatide

  • Placebo comparator
    placebo

    matching placebo subcutaneous injection once

    Drug: Placebo

Interventions

  • DrugTirzepatide

    2.5mg subcutaneous injection once

  • DrugPlacebo

    Saline placebo subcutaneous injection once

05

What researchers measure

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.

    Time frame: 5 weeks

Secondary outcomes

  1. Serious adverse event

    Incidence of serious adverse events

    Time frame: 5 weeks

  2. 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.

    Time frame: 5 weeks

  3. Abstinence

    Percent days abstinent from cannabis

    Time frame: 5 weeks

  4. Weight

    Weight

    Time frame: 5 weeks

  5. Blood sugar

    Blood glucose

    Time frame: 5 weeks

  6. Hemoglobin A1c

    Hemoglobin A1c

    Time frame: 5 weeks

  7. Depression severity as measured by the Patient Health Questionnaire-8 (PHQ-8)

    Depression severity as measured by the Patient Health Questionnaire-8 (PHQ-8). The PHQ-8 assesses depression severity over the past two weeks. Total scores range from 0 to 24, with higher scores indicating greater depression severity (worse outcome). Score interpretation: 0-4 (none), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), 20-24 (severe depression).

    Time frame: 5 weeks

  8. Anxiety severity as measured by the Generalized Anxiety Disorder-7 scale (GAD-7)

    The GAD-7 assesses anxiety symptom severity over the past two weeks. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity (worse outcome). Score interpretation: 0-4 (minimal anxiety), 5-9 (mild), 10-14 (moderate), 15-21 (severe anxiety).

    Time frame: 5 weeks

  9. Suicidality as measured by the C-SSRS (Columbia-Suicide Severity Rating Scale)

    The C-SSRS assesses the presence and severity of suicidal ideation and behavior. Suicidal ideation severity scores range from 0 to 5 (0=no ideation, 1=wish to be dead, 2=non-specific active suicidal thoughts, 3=active suicidal ideation with methods, 4=suicidal intent, 5=suicidal intent with plan), with higher scores indicating greater severity (worse outcome). The scale also captures suicidal behavior as binary yes/no responses.

    Time frame: 5 weeks

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07265752
Lead sponsor
Brigham and Women's Hospital
Responsible party
Joji Suzuki, MD (Principal Investigator, Division of Addiction Treatment and Prevention, AMC Psychiatry Mass General Brigham, Brigham and Women's Hospital) — Principal investigator
First posted
Dec 5, 2025
Start date
Mar 1, 2027 (estimated)
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Sep 24, 2026

Study contacts

Mary R Shen, MD
Contact
mshen4@bwh.harvard.edu
6177325752
Joji Suzuki
principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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