Randomized, controlled trial of Rybelsus (semaglutide) among adults with AUD

Primary Objective

We are doing this study to learn more about whether a drug called semaglutide (Rybelsus®) affects behaviors associated with Alcohol Use Disorder (AUD). Semaglutide is approved by the Food and Drug Administration (FDA) for the treatment of Type 2 diabetes but is not approved for AUD treatment.

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Description

You will be randomly assigned to one of two groups. You will have a 50% (1 in 2) chance of receiving semaglutide and a 50% chance of receiving placebo. This is a double-blind study, which means neither you nor the study investigator will make the choice to which group you are assigned, and neither will know what group you are in. There are 8 study visits over about 11 weeks, including weekly study visits for 7 weeks, plus a follow-up phone call about two weeks after the last study visit. Compensation is provided for participation.

Details
Age
Adult
Eligibility
- Age 21 or older - Drink regularly and meet criteria for Alcohol Use Disorder (AUD) - Interested in reducing or stopping your alcohol useNot everyone will qualify to be in the study. Other inclusion and exclusion criteria will be evaluated by the study team.
Locations

Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Joseph Schacht

Joseph Schacht

Study ID

Protocol Number: 23-0261

More information available at ClinicalTrials.gov: NCT05892432

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