Abstract / Summary
An earlier trial of injectable semaglutide found that the drug resulted in improved drinking outcomes, but participants in that study had lower-severity AUD and were not seeking treatment.There is a need for additional research to evaluate the effects of GLP-1s in treatment-seeking individuals, who generally have higher-severity AUD.Investigators led by Joseph P. Schacht, Ph.D., professor in the Department of Psychiatry at the University of Colorado Anschutz School of Medicine, conducted a study to evaluate the effects of oral semaglutide on alcohol consumption and craving in treatmentseeking adults with AUD. Study methodsThe study enrolled adults aged 21 and older who met DSM-5 criteria for moderate to severe AUD and had a body mass index of 25 or higher.Participants reported consuming an average of 28 or more drinks for men and 21 or more drinks for women over the past 28 days.Among those excluded were individuals with a current moderate or severe non-alcohol substance use disorder or a current psychiatric disorder.Participants were randomized to oral semaglutide or placebo for 8 weeks, with dosages starting at 3 mg/day and increasing to 7 mg/day after 4 weeks.The investigators used the model of the National Institute on Alcohol Abuse and Alcoholism' s (NIAAA' s) Human Laboratory Program at screening and week 6 of the trial to measure participant response after a 3-minute exposure to their preferred alcoholic beverage.The primary outcome measure was participant response at week 6 to the question "How strong is your craving to drink alcohol?" after alcohol exposure.Secondary outcomes included number of drinks consumed per day and number of heavy-drinking days.Exploratory outcomes included alcohol-related negative consequences as measured with the Patient-Reported Outcomes Measurement Information System and change in World Health Organization (WHO) risk drinking level between baseline and week 8.