๐ฌIn plain words
What the trial is, and whether it could suit you
This is a pilot, 4-week, double-blind, placebo-controlled, randomized trial of individuals with alcohol use disorder (AUD) to receive weekly injections of either tirzepatide (n=10) or matching placebo (n=10). The primary aim is to determine the effects of tirzepatide on cue-reactivity among individuals with AUD. The secondary aim is to assess the safety and preliminary efficacy of tirzepatide for AUD.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* English speaking adults aged 18 and above
* Diagnosed with current DSM-5 alcohol use disorder
* Willing and able to physically travel to BWH CCI outpatient facilities for study visits
Exclusion Criteria:
* CIWA score at screening โฅ 8.
* Psychotic disorder, active suicidality or homicidality or any psychiatric condition that impair ability to provide informed consent
* Any lifetime diagnosis of eating disorders including anorexia, bulimia, binge eating, or avoidant/restrictive food intake disorder
* BMI\<23 mg/kg2
* Current or lifetime diagnosis of Type 1 or Type 2 diabetes
* Current (or within 30 days of enrollment) use of any anti-obesity medications or medications with glucose lowering properties (including GLP-1 analogues, sulfonylurea, insulin, metformin, thiazolidinediones, dipeptidyl peptidase-4 (DPP-IV) inhibitors, or sodium-glucose cotransporter-2 (SGLT-2) inhibitors)
* Use of any GLP-1 agonist medications in the prior 3 months
* Anticipating receipt of any other GLP-1 agonist medications during the trial
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
* Current hypoglycemia as indicated by a blood sugar level of โค70 mg/dL measured at the baseline visit
* Calcitonin โฅ 50 ng/L
* Triglycerides โฅ500 mg/dL
* Untreated cholelithiasis or gallbladder disease
* Acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or congestive heart failure in the last 90 days
* Uncontrolled hypertension at baseline, as indicated by an average blood pressure reading of \>180/110 after three successive readings
* History of inflammatory bowel disease, bariatric surgery, pancreatitis, diabetic gastroparesis, or non-arteritic anterior ischemic optic neuropathy
* Liver function test greater than 5 times upper normal limit
* Renal impairment as indicated by eGFR of \<30
* History of hypersensitivity or allergy to tirzepatide
* Pregnant or breastfeeding
* Anticipated to be enrolled in another clinical drug trial during participation in this trial
* Any other reason or clinical condition that the investigators judge may interfere with study participation and/or be unsafe for a participant