Cannabis Use DisorderPhase 2NCT07265752
Tirzepatide for the Treatment of Cannabis Use Disorder
A Phase 2 study testing Tirzepatide in people with Cannabis Use Disorder, run by Brigham and Women's Hospital.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2027to 30 Jun 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking adults aged 18 and above
- Diagnosed with DSM-5 cannabis use disorder, severe
Who cannot join
- 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
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- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Tirzepatide for the Treatment of Cannabis Use Disorder: A Pilot Double-blind, Placebo-controlled, Crossover Trial
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.
- Conditions
- Cannabis Use Disorder
- Being tested
- Tirzepatide, Placebo
- Keywords
- tirzepatide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
2.5mg subcutaneous injection once
PlaceboDrug
Saline placebo subcutaneous injection once
| Study group | Role | What they receive |
|---|---|---|
| tirzepatide | Experimental | 2.5mg subcutaneous injection once Receives: Drug: Tirzepatide |
| placebo | Placebo comparator | matching placebo subcutaneous injection once Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
Secondary outcomes (9)
Serious adverse event
Incidence of serious adverse events
Measured: 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.
Measured: 5 weeks
Abstinence
Percent days abstinent from cannabis
Measured: 5 weeks
Weight
Weight
Measured: 5 weeks
Blood sugar
Blood glucose
Measured: 5 weeks
Hemoglobin A1c
Hemoglobin A1c
Measured: 5 weeks
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).
Measured: 5 weeks
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).
Measured: 5 weeks
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.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Mar 2027 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joji Suzuki, MD, Brigham and Women's Hospital
- Investigators
- Joji Suzuki, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265752
- Sponsor's protocol ID
- 2025P002984
- Status last verified
- Oct 2026
- First submitted
- 25 Nov 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No