Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07265752

Tirzepatide for the Treatment of Cannabis Use Disorder

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Cannabis Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tirzepatide

Drug

2.5mg subcutaneous injection once

Placebo

Drug

Saline placebo subcutaneous injection once

Primary outcomes

  1. Cue-Induced Craving

    Time frame: 5 weeks

    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.

Secondary outcomes

  1. Serious adverse event

    Time frame: 5 weeks

    Incidence of serious adverse events

  2. Cravings

    Time frame: 5 weeks

    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.

  3. Abstinence

    Time frame: 5 weeks

    Percent days abstinent from cannabis

  4. Weight

    Time frame: 5 weeks

    Weight

  5. Blood sugar

    Time frame: 5 weeks

    Blood glucose

  6. Hemoglobin A1c

    Time frame: 5 weeks

    Hemoglobin A1c

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

    Time frame: 5 weeks

    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).

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

    Time frame: 5 weeks

    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).

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

    Time frame: 5 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mary R Shen, MD

CONTACT

[email protected]

6177325752

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Tirzepatide for the Treatment of Cannabis Use Disorder: A Pilot Double-blind, Placebo-controlled, Crossover Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 5, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.