This study will examine two doses of 1.0 mg and 2.0 mg of Semaglutide versus placebo in patients with Alcohol Use Disorder (AUD) and Obesity (Ob) to assess if these doses improve alcohol craving, stress and alcohol use outcomes.
A randomized, double blind placebo controlled 20 week study of two doses of Semaglutide (SEMA) versus placebo in men and women with AUD and obesity (OB:BMI 30-49.9 kg/m2) will be studied to assess alcohol and food craving and stress in a validated laboratory model as well as examine changes in alcohol intake and related alcohol use outcomes during a 20 week clinical treatment and 8 week post-treatment follow-up phase of the study, in order to test mechanisms by which SEMA may exerts significant effects on alcohol use disorder outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
90
Placebo - administered one weekly for 20 weeks
Semaglutide 1.0 mg low dose
Semaglutide 2.0 mg high dose
Yale Stress Center
New Haven, Connecticut, United States
Alcohol use days
Days of alcohol use over 20 weeks of treatment
Time frame: 20 weeks
Heavy drinking days
Days of heavy drinkings (Mne: greater than 5 or more drinks; Women: greater than 4 or more drinks)
Time frame: 20 weeks
Average drinks per drinking day
Average number of alcoholic drinks consumed on a drinking day
Time frame: 20 weeks
Obsessive Compulsive Drinking Scale (OCDS) to assess Alcohol craving
The OCDS is a 14-item self-report tool that measures alcohol craving, obsessive thoughts about drinking, and compulsive drinking behaviors. Total scores and subscale scores range from 0 to 40, with higher scores reflecting more overall craving in each category and total craving.
Time frame: 20 weeks
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