Tirzepatide Combined With Cognitive-Behavioural Therapy (CBT) for Adults With Alcohol Use Disorde… (NCT07292519) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Tirzepatide Combined With Cognitive-Behavioural Therapy (CBT) for Adults With Alcohol Use Disorder (AUD) and Overweight/Obesity (OOB)
Australia46 participantsStarted 2026-01-15
Plain-language summary
The investigators approach is to conduct a Phase II Double-Blind randomised controlled trial with individuals with co-occurring Alcohol Use Disorder and overweight/obesity (AUD-OOB) to receive either a sub-cutaneous injection of Tirzepatide (2.5 mg for 4 weeks followed by 5 mg for 4 weeks) or visually matched sham saline injection, in combination with a structured behavioural intervention (Take Control CBT Module). The primary aim of the study is evaluate the efficacy of the intervention on the number of heavy drinking days (defined as 5+ standard drinks for men, 4+ standard drinks for women) during the final month of treatment (weeks 5 to 8) compared to baseline. The secondary aim of the study is to assess treatment effects on alcohol related (e.g. number drinks consumed per day, abstinent days) and cardio-metabolic outcomes (e.g. body weight in kg, waist circumference, blood pressure, HbA1c, total cholesterol etc...), and summarise safety outcomes associated with use (e.g. frequency and severity of side effects, number of serious adverse events, treatment related discontinuations). The study will also include neurobiological assessments such as functional magnetic resonance imaging (fMRI) and lab-based psychophysiology to assess the impact of tirzepatide on change in brain activity and autonomic responses to alcohol and food cues.
Who can participate
Age range21 Years – 75 Years
SexALL
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Inclusion criteria
✓. Aged 21 to 75 years
✓. Meet DSM-5 criteria for alcohol use disorder (AUD) with at least moderate severity (≥4 symptoms in the past year)
✓. Have an average daily alcohol consumption of:
✓. Body mass index (BMI) ≥27 kg/m²
✓. Currently motivated to reduce or stop drinking but not engaged in formal AUD treatment
✓. Able and willing to attend weekly clinic visits and complete all study procedures
✓. Fluent in English and able to provide informed consent
✓. Stable housing situation (not transient or homeless)
Exclusion criteria
✕. Past-year DSM-5 diagnosis of another substance use disorder (except nicotine or mild cannabis use disorder)
✕. Recent (past 30 days) self-reported illicit drug use (excluding cannabis), or a positive urine drug screen for non-cannabis substances
What they're measuring
1
Heavy Drinking Days
Timeframe: 12 weeks (measured at baseline, during the final 4 weeks of treatment [weeks 5 - 8], end of treatment [week 9], and follow-up [week 12]).