NCT05520775

Semaglutide for Alcohol Use Disorder

Human Laboratory Screening of Semaglutide for Alcohol Use Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is an early-Phase II human laboratory trial using a randomized, placebo-controlled, dose-ranging design to investigate the effects of semaglutide, a GLP-1 receptor agonist, on alcohol-related outcomes in adults with alcohol use disorder (AUD).

Detailed description

This is an early-Phase II human laboratory trial using a randomized, placebo-controlled, dose-ranging design to investigate the effects of semaglutide, a GLP-1 receptor agonist, on laboratory alcohol responses and consumption, naturalistic alcohol consumption, and weight loss in participants with alcohol use disorder (AUD). Participants will attend weekly visits while semaglutide dosage is increased to 1.0mg over a period of approximately 9-10 weeks. Participants will attend weekly visits for medication or placebo administration. At scheduled intervals, participants will complete 4 laboratory sessions involving alcohol self-administration and alcohol challenge to characterize medication effects on alcohol-related outcomes.

Conditions

• Alcohol Use Disorder
• Cigarette Smoking

Interventions

Type	Name	Description
DRUG	Semaglutide	Semaglutide (subcutaneous)
DRUG	Sham/placebo	Sham subcutaneous injection

Timeline

• Start date: 2022-09-02
• Primary completion: 2024-04-12
• Completion: 2024-04-19
• First posted: 2022-08-30
• Last updated: 2025-04-02
• Results posted: 2025-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study