About this trial
This clinical trial aims to test the effectiveness and safety of semaglutide, a GLP-1 receptor agonist, in treating moderate to severe alcohol use disorder (AUD) in Veterans. Participants who qualify will be randomly assigned to receive either semaglutide injections or placebo injections over a 24-week period, followed by a 4-week post-treatment safety assessment period. Participants receiving semaglutide will start with a low dose, gradually increasing to a maximum of 2.4 milligrams (mg) per week, depending on their tolerance. The primary measure of success will be a reduction in risky drinking, assessed through a reliable calendar-based interview method called the Timeline Follow-Back (TLFB), a well-validated calendar-based interview technique for recording daily alcohol consumption. The purpose of this research is to gather information on the safety and effectiveness of semaglutide for treating AUD, potentially offering a new and more appealing treatment option.
Eligibility criteria
Qualifiers
Veteran
WHO risk drinking level of Very High or High in the 28 days prior to screening (based on screening TLFB)
Current diagnosis of moderate or severe AUD (i.e., meeting at least 4 of 11 DSM-5 AUD criteria) based on semi-structured diagnostic exam (MINI)
Able and willing to provide informed consent
Disqualifiers
Medical History (medical history form)
Type 1 diabetes
History of acute or chronic pancreatitis
History of diabetic ketoacidosis
Trial design
Treatments tested in this trial
- Semaglutide
- Placebo