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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Tirzepatide
DrugThis 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.
Saline Placebo
Other interventionPlacebo syringes of saline and matching volume will be produced by IDS.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: TirzepatideExperimental treatment 1 intervention
Group B: Saline PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cue-induced Cravings for Alcohol
Cue-induced craving scores at follow-up compared to baseline using a standard cue-reactivity paradigm utilizing visual cues. Cravings will be measured on a scale from 0-10 with 10 meaning extreme cravings.
Time frame
Baseline visit and 5 weeks after baseline visit.2
Incidence and Severity of Adverse Events
Study staff will be notified of any hospital admissions via Epic, and adverse events will be queried specifically using the Patient Rated Inventory of Side Effects (PRISE) at study weeks 2-5. The PRISE is a self-report tool to qualify side effects. For each domain, the patient indicates whether they have experienced certain symptoms and whether the symptoms are tolerable or distressing.
Time frame
Epic monitoring throughout the trial and PRISE administered at study weeks 2-5 (visits 3-6).Secondary outcomes
1
Penn Alcohol Craving Scale (PACS)
A self-report tool used to measure craving for alcohol during the past week. Participants respond to 5 questions on a scale of 0-6 for a total score of 0-30, with higher scores indicating stronger cravings.
Time frame
At each study visit up to and including the final visit 5 weeks after baseline.2
Monetary Choice Questionnaire (MCQ)
A self-report tool used to measure delayed discounting. Participants will be asked to pick one of the two choices given. Score calculated typically falls between 0.0 and 0.5, with smaller values indicating a lack of discounting and preference for delayed rewards and higher values indicating strong discounting and a preference for immediate rewards.
Time frame
Baseline visit and 5 weeks after baseline visit.3
Visual Probe Task
A behavioral task to assess attentional bias. Alcohol-related and neutral images will be used, different from the ones used for the cue-reactivity paradigm to limit habituation. A pair of images will appear on the left and right of the screen for either a short (200ms) or long (500ms) stimulus duration to assess automatic orientating and controlled attention processing, respectively. Image pairs will be replaced by a probe in the location of either the opioid-related or neutral image. The probe will remain until the participant responds to identify the probe orientation by pressing the response keys as quickly as possible. This task will yield reaction times for analysis.
Time frame
Baseline visit and 5 weeks after baseline visit.4
Percent days abstinent
The percentage of days abstinent from alcohol, defined as 0 drinks on a given day, out of all days queried. The study investigators will use the Time-Line Follow Back (TLFB), a gold-standard method of evaluating substance use, as well as weekly urine toxicology screens.
Time frame
At each study visit up to and including the final visit 5 weeks after baseline.Sponsors and contacts
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Source ClinicalTrials.gov