Cannabis Use Disorder
Conditions
Keywords
tirzepatide
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.
Interventions
DRUGTirzepatide
2.5mg subcutaneous injection once
DRUGPlacebo
Saline placebo subcutaneous injection once
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind placebo-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cue-Induced Craving | 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
| Measure | Time frame | Description |
|---|---|---|
| Cravings | 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. |
| Abstinence | 5 weeks | Percent days abstinent from cannabis |
| Weight | 5 weeks | Weight |
| Blood sugar | 5 weeks | Blood glucose |
| Serious adverse event | 5 weeks | Incidence of serious adverse events |
| Depression severity as measured by the Patient Health Questionnaire-8 (PHQ-8) | 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). |
| Anxiety severity as measured by the Generalized Anxiety Disorder-7 scale (GAD-7) | 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). |
| Suicidality as measured by the C-SSRS (Columbia-Suicide Severity Rating Scale) | 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. |
| Hemoglobin A1c | 5 weeks | Hemoglobin A1c |
Contacts
Primary ContactMary R Shen, MD
Outcome results
None listed