Tirzepatide for the Treatment of Cannabis Use Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tirzepatide, Placebo.
- Who it may be relevant to
- Registry conditions: Cannabis Use Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Tirzepatide for the Treatment of Cannabis Use Disorder: A Pilot Double-blind, Placebo-controlled, Crossover Trial
Overview
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.
Interventions
- Drug Tirzepatide
2.5mg subcutaneous injection once - Drug Placebo
Saline placebo subcutaneous injection once
Primary outcome measures
- Cue-Induced Craving [Time frame: 5 weeks]
Secondary outcome measures (9)
- Serious adverse event [Time frame: 5 weeks]
- Cravings [Time frame: 5 weeks]
- Abstinence [Time frame: 5 weeks]
- Weight [Time frame: 5 weeks]
- Blood sugar [Time frame: 5 weeks]
- Hemoglobin A1c [Time frame: 5 weeks]
- Depression severity as measured by the Patient Health Questionnaire-8 (PHQ-8) [Time frame: 5 weeks]
- Anxiety severity as measured by the Generalized Anxiety Disorder-7 scale (GAD-7) [Time frame: 5 weeks]
- Suicidality as measured by the C-SSRS (Columbia-Suicide Severity Rating Scale) [Time frame: 5 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07265752 · 2025P002984