Semaglutide for Alcoholism
What You Need to Know Before You Apply
What is the purpose of this trial?
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 is safe and 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.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, including those for lowering glucose, weight-loss drugs, and FDA-approved treatments for alcohol use disorder, at least 30 days before participating. If you are on any of these medications, you will need to stop them to join the study.
Is semaglutide safe for humans?
How does the drug Semaglutide differ from other treatments for alcoholism?
Semaglutide is unique because it is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) originally used for type 2 diabetes, which may help with weight loss and potentially reduce alcohol cravings. Unlike traditional alcoholism treatments, it is administered once weekly as an injection or taken orally, offering a novel approach by targeting metabolic pathways.12467
What data supports the effectiveness of the drug Semaglutide for treating alcoholism?
Semaglutide, a drug used for type 2 diabetes, has shown effectiveness in controlling blood sugar levels and promoting weight loss. While it is not directly studied for alcoholism, its ability to influence weight and metabolism might suggest potential benefits in managing alcohol-related health issues.12456
Who Is on the Research Team?
Lorenzo Leggio, M.D.
Principal Investigator
National Institute on Drug Abuse (NIDA)
Are You a Good Fit for This Trial?
Adults aged 18 or older with Alcohol Use Disorder (AUD) who drink more than a moderate amount weekly and can understand English may join. They shouldn't be on other AUD treatments, have unstable heart conditions, extreme body weight, certain blood test abnormalities, diabetes, or be pregnant. Those with specific medical histories like thyroid cancer or severe allergies to similar drugs are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive weekly subcutaneous injections of semaglutide or placebo for 20 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Semaglutide
- Take Control
Semaglutide is already approved in European Union, United States, Canada, Japan for the following indications:
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Who Is Running the Clinical Trial?
National Institute on Drug Abuse (NIDA)
Lead Sponsor