Actively Recruiting
Semaglutide Therapy for Alcohol Reduction (STAR)
Led by National Institute on Drug Abuse (NIDA) · Updated on 2026-05-12
80
Participants Needed
1
Research Sites
376 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Alcohol use disorder (AUD) is a problematic pattern of alcohol use accompanied by clinically significant medical consequences. Medications can help most people reduce their drinking, but the number is limited, and additional treatment options are needed. Objective: To test if a medication named Semaglutide may reduce alcohol drinking in people with AUD. Who can participate? All Adults aged 18 or older with AUD might be eligible to participate in the study. What will happen during the study? Participants will visit the National Institute on Drug Abuse (NIDA) in Baltimore once a week for about 20 weeks (5 months). Each visit will last between 2 and 6 hours depending on the tasks scheduled for that visit. Participants will be assigned by chance (like flipping a coin) to receive either Semaglutide or placebo. A placebo looks just like a real drug but contains no medicine. The study medication is given as a shot under the skin each week. Participants will undergo different tests throughout the study: They will give blood, urine, and saliva samples. They will engage in self-paced behavioral therapy on a computer. They will answer questions about their mood, diet, alcohol drinking and craving, tobacco use, etc. They will taste several sweet liquids and tell their preferences. They will sit in a bar-like room and be exposed to cues that might make them feel the urge to eat food or drink alcohol. They will wear a virtual reality headset that creates a cafeteria setting. They will walk the virtual cafeteria and choose food and drinks from a buffet. They will have a functional magnetic resonance imaging (fMRI) scan to take pictures of their brain. During the scans, participants will be shown pictures of alcohol-containing drinks, food, and other items.They will perform tasks on a computer screen. Participants will have a follow-up visit about 7 weeks after their last shot.
CONDITIONS
Official Title
Semaglutide Therapy for Alcohol Reduction (STAR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Current diagnosis of Alcohol Use Disorder with at least 2 symptoms on a validated tool
- For females, drinking more than 7 drinks per week during the past 28 days; for males, more than 14 drinks per week
- At least four days with more than 3 drinks for females or more than 4 drinks for males during the past 28 days
- Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score less than 10
- Able to speak, read, write, and understand English
- Normal or corrected normal vision and hearing
You will not qualify if you...
- Body mass index (BMI) less than 23 kg/m² or 50 kg/m² or higher
- Evidence of malnutrition
- Blood test abnormalities including creatinine 2 mg/dL or higher, eGFR less than 45 mL/min/1.73 m², triglycerides over 500 mg/dL, or abnormal liver enzymes
- Diagnosis of diabetes or hemoglobin A1c 6.5% or higher
- Current use (within 30 days) of glucose-lowering medications including GLP-1 analogues, sulfonylurea, insulin, metformin, thiazolidinediones, DPP-IV inhibitors, or SGLT-2 inhibitors
- Current or prior use of semaglutide or tirzepatide
- Current use (within 30 days) of weight-lowering medications
- Current use (within 30 days) of FDA-approved medications for AUD
- Use of medications that interact with semaglutide
- Personal or family history of medullary thyroid carcinoma or MEN type 2
- History of alcohol ketoacidosis, gastroparesis, pancreatitis, pancreatic cancer, gallbladder disease, jaundice, esophageal tears, varices, or cirrhosis
- History of gastric bypass surgery
- Known allergy to semaglutide or any GLP-1 analogue
- History of suicide attempts in past 24 months or active suicidal thoughts
- Significant vestibular disorders or motion sickness
- Clinically significant hearing loss or tinnitus
- Contraindications for brain fMRI
- Unstable heart conditions
- Clinically unstable mental or physical health conditions
- Female who is pregnant, breastfeeding, or plans pregnancy without effective contraception
- Any other condition that may interfere with study participation or safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institute on Drug Abuse
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
M
Masoumeh Dejman
CONTACT
L
Lorenzo Leggio, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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