The purpose of this research study is to evaluate the feasibility of treating Alcohol Use Disorder with Semaglutide after metabolic and bariatric surgery in adults with overweight or obesity.
This study aims to evaluate the feasibility and acceptability of treating Alcohol Use Disorder with Semaglutide after metabolic and bariatric surgery in adults with overweight/obesity. This study will also examine changes in alcohol use disorder and weight. It is hypothesized that the treatment will be feasible and acceptable to participants, and result in reductions in alcohol use and weight. A recently published randomized controlled trial provided preliminary evidence that Semaglutide can reduce some alcohol craving and drinking outcomes; however, this has not been examined in individuals with a history of bariatric surgery who are at increased risk of alcohol misuse and Alcohol Use Disorder.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
4
Participants randomized to Semaglutide will be initiated on a 0.25 mg dose (injection) once weekly for 4 weeks (first month) with an escalation to 0.5 mg for the second month, and 1.0 mg in the final month (three months total).
Yale School of Medicine
New Haven, Connecticut, United States
Percent weight change
Percent weight change will be calculated. Negative values are indicative of weight loss. Positive values are indicative of weight gain.
Time frame: Baseline, Week 12, 6-month follow-up
Mean drinks per calendar day to assess alcohol use
Mean drinks per calendar day will be assessed through timeline follow back interviews
Time frame: Baseline, Week 4, Week 8, Week 12, 6-month follow-up
Mean drinks per drinking day to assess Alcohol use
Mean drinks per drinking day will be assessed through timeline follow back interviews
Time frame: Baseline, Week 4, Week 8, Week 12, 6-month follow-up
Mean number of heavy drinking days to assess Alcohol use
Mean number of heavy drinking days will be assessed through timeline follow back interviews
Time frame: Baseline, Week 4, Week 8, Week 12, 6-month follow-up
Mean number of drinking vs abstinent days to assess Alcohol use
Mean number of drinking vs abstinent days will be assessed through timeline follow back interviews
Time frame: Baseline, Week 4, Week 8, Week 12, 6-month follow-up
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