Study of Tirzepatide for Recovery and Alcohol Use Management
ConditionAlcohol Use Disorder (AUD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Tirzepatide
- Saline Placebo
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov