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Semaglutide Therapy for Alcohol Reduction (STAR)

NCT06015893 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-12

No results posted yet for this study

Summary

Background:

Alcohol use disorder (AUD) is a problematic pattern of alcohol use accompanied by clinically significant medical consequences. Medications can help most people reduce their drinking, but the number is limited, and additional treatment options are needed.

Objective:

To test if a medication named Semaglutide may reduce alcohol drinking in people with AUD.

Who can participate?

All Adults aged 18 or older with AUD might be eligible to participate in the study.

What will happen during the study?

Participants will visit the National Institute on Drug Abuse (NIDA) in Baltimore once a week for about 20 weeks (5 months). Each visit will last between 2 and 6 hours depending on the tasks scheduled for that visit.

Participants will be assigned by chance (like flipping a coin) to receive either Semaglutide or placebo. A placebo looks just like a real drug but contains no medicine.

The study medication is given as a shot under the skin each week.

Participants will undergo different tests throughout the study:

They will give blood, urine, and saliva samples.

They will engage in self-paced behavioral therapy on a computer.

They will answer questions about their mood, diet, alcohol drinking and craving, tobacco use, etc.

They will taste several sweet liquids and tell their preferences.

They will sit in a bar-like room and be exposed to cues that might make them feel the urge to eat food or drink alcohol.

They will wear a virtual reality headset that creates a cafeteria setting. They will walk the virtual cafeteria and choose food and drinks from a buffet.

They will have a functional magnetic resonance imaging (fMRI) scan to take pictures of their brain. During the scans, participants will be shown pictures of alcohol-containing drinks, food, and other items.They will perform tasks on a computer screen.

Participants will have a follow-up visit about 7 weeks after their last shot.

Conditions

Interventions

BEHAVIORAL

Take Control

A computer-delivered behavioral therapy derived from the NIAAA s self-help approach, Rethinking Drinking, developed for use in pharmacotherapy trials.

DRUG

Semaglutide

Weekly subcutaneous (s.c.) injections of semaglutide (or placebo) up to 2.4 mg/week or maximum tolerated dose (MTD).

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

  • Lorenzo Leggio, M.D. · National Institute on Drug Abuse (NIDA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-17
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06015893 on ClinicalTrials.gov