We are looking for people who are overweight and want to cut back or stop drinking. This is for a study to see how a medicine called semaglutide (Rybelsus®) might help with Alcohol Use Disorder (AUD) and the behaviors associated with it.
This study will help us learn more about whether the study medication has an impact on alcohol use and craving. Your participation will contribute to scientific knowledge and may lead to information that could help patients and healthcare providers in the future.
First, we’ll talk with you on the phone and ask a few questions. Then, we’ll set up a time for you to come to campus for a screening visit. At this visit, you will fill out surveys and answer questions about your health and medication use. We will check your vitals and take a blood and urine sample. The study doctor will do a physical exam and we will ask you about your alcohol use and cravings. If you qualify for the study, you will be placed in one of two groups by chance (like flipping a coin). You will have a 1 in 2 chance of getting semaglutide and a 1 and 2 chance of getting a placebo (a pill with no medicine). You won’t get to choose your group. You and the study team won’t know which group you are in. Semaglutide is a medicine that the FDA has approved to treat Type 2 diabetes but is not approved for AUD treatment. You will take your study medicine by mouth every morning for 8 weeks. You will have 7 more visits. At these visits, you will do many of the same tests and surveys that you did before. At two of the visits, you will get an MRI. An MRI is a machine that uses strong magnets to take pictures of your body and show how your brain works.
There are 8 visits over about 11 weeks. For 7 of those weeks, you will come once per week. The visits take about 17 hours total. About two weeks after the last visit, we will call you for a short follow-up. This call takes about 15 to 30 minutes.
You may be able to join this study, if you:
• Are 21 or older
• Drink regularly and meet criteria for Alcohol Use Disorder (AUD)
• Are interested in reducing or stopping your alcohol use
• Are overweight (body mass index of 25 or higher)
Not everyone will qualify to be in the study. Other inclusion and exclusion criteria will be evaluated by the study team.
Protocol Number: 23-0261
More information available at ClinicalTrials.gov: NCT05892432
Principal Investigator