Brigham and Women's Hospital
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.
Participants include N=20 men and women with DSM5 diagnosis of AUD. Potential participants will be screened and enrolled only if they meet full inclusion criteria. After screening and baseline procedures (Visit 1) are complete, participants will be randomized to receive either tirzepatide or placebo. Following randomization, participants will be scheduled for five study visits (Visits 2-6). Each visit will last approximately 1 hour, except for study visits 1 and 6 which will take no more than 3 hours in order to conduct additional neurocognitive testing, including cue-induced cravings and deci…
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 ≥ 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 diab…
This intervention will consist of the FDA-approved dosing schedule. Participants will receive 2.5mg weekly injections for 4 weeks. IDS will extract tirzepatide and draw the doses into syringes.
Placebo syringes of saline and matching volume will be produced by IDS.
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