Tirzepatide plus talking therapy for adults with alcohol use disorder and excess weight

Trial details

Who runs it

South West Sydney Local Health District

Trial code

NCT07292519

Record updated

18 December 2025

Original description

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.Read full original descriptionShow less

Tirzepatide Combined With Cognitive-Behavioural Therapy (CBT) for Adults With Alcohol Use Disorder (AUD) and Overweight/Obesity (OOB)

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.

Inclusion: 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:; ≥60g ethanol/day for men; ≥40g ethanol/day for women (based on the 28 days prior to the baseline visit); 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: Recent (past 30 days) self-reported illicit drug use (excluding cannabis), or a positive urine drug screen for non-cannabis substances; Currently engaged in pharmacological or behavioral treatment for AUD, or prior engagement within the past 3 months; Use of any weight loss medication (e.g., orlistat, bupropion-naltrexone) or AUD medication (e.g., naltrexone, acamprosate, topiramate, varenicline) in the past 3 months; Participation in another clinical trial involving an investigational product; Scheduled for surgery requiring anaesthesia within 90 days of enrolment that would interfere with participation or follow-up; Presence of any MRI-incompatible metal implants or devices, including pacemakers, aneurysm clips, insulin pumps, or cochlear implants; Prior occupation as a machinist, welder, or metal worker (due to risk of metal fragments); Past-year DSM-5 diagnosis of another substance use disorder (except nicotine or mild cannabis use disorder); History of significant alcohol withdrawal, defined by:; History of seizure, delirium tremens, or; Hospitalisation for withdrawal, or; CIWA-Ar score >9, or; PAWS score >4 at screening; Significant psychiatric illness, including:; Current active suicidal ideation (per C-SSRS); Lifetime history of psychosis or bipolar disorder; Unstable depression or anxiety interfering with daily functioning; Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type I/II; History of muscle wasting, bone disorders (e.g. sarcopenia); Active gastrointestinal conditions that could interfere with treatment (e.g., severe GERD); Uncontrolled hypertension, recent heart attack or stroke (within 6 months); Extra Exclusion criteria for Those Participants Agreeing to Participate in Neuroimaging \& Psychophysiology Tasks:; History of brain surgery or penetrating head trauma; History of claustrophobia likely to interfere with scanning compliance aa. Neurological disorders (e.g., epilepsy, multiple sclerosis) likely to confound neuroimaging data bb. Inability to lie still or tolerate MRI procedures cc. Patient weighting over 159kg (MRI scan limit) dd. Any other condition or medication judged by the investigator to preclude safe participation; History or current diagnosis of:; Type 1 or Type 2 diabetes; Diabetic complications (e.g. retinopathy); HbA1c ≥6.5% at screening; Significant liver disease or abnormal liver function tests (ALT, AST, ALP, bilirubin >3× ULN); Estimated glomerular filtration rate (eGFR) <30 mL/min; Chronic or acute pancreatitis; Recent significant weight loss (>5% of body weight in past 30 days); Use of tirzepatide or any GLP-1 receptor agonist in the past 6 months; Pregnant or breastfeeding, or not using effective contraception (females of childbearing potential); Inability to attend weekly visits due to work/travel/schedule conflicts; Shared household with a current or past participant in this trial; Non-removable piercings or dental hardware that would interfere with MRI.

ClinicalTrials.gov NCT07292519