Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:13 PM
Study NCT ID:
NCT06015893
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2023-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Semaglutide Therapy for Alcohol Reduction (STAR)
Sponsor:
National Institute on Drug Abuse (NIDA)
Organization:
Study Overview
Official Title:
Semaglutide Therapy for Alcohol Reduction (STAR): A Proof-of-Concept Phase II Clinical Trial
Status:
RECRUITING
Status Verified Date:
2025-11-26
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 is safe and 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.
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 is safe and 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.
Detailed Description:
Study Description:
This study will test the safety/tolerability and early efficacy of subcutaneous (s.c.) semaglutide at the dose of 2.4 mg/week or maximum tolerated dose (MTD) as a potential new treatment for alcohol use disorder (AUD).
Objectives:
We propose to test safety/tolerability and early efficacy of semaglutide, a glucagon-like peptide-1 (GLP-1) analogue, as a novel pharmacotherapy to reduce alcohol use and related measures. This will be a Phase 2a, pilot, proof-of-concept, outpatient study combined with experimental medicine human laboratory procedures.
Endpoints:
The co-primary aims will be to determine whether A) semaglutide is safe and tolerable in individuals with AUD, as measured by the frequency/severity of adverse events and the proportion of participants who reach maximum dose, and B) semaglutide reduces alcohol drinking from baseline to endpoint, as measured by total number of standard alcohol-containing drinks consumed per week (drinks per week, DPW).
The following secondary aims will also be examined:
* Whether semaglutide reduces other self-reported alcohol-related outcomes (e.g., heavy drinking days, drinks per drinking days, World Health Organization (WHO) drinking levels)
* Whether semaglutide reduces blood Phosphatidylethanol (PEth) levels as a biomarker of alcohol use
* Whether semaglutide reduces alcohol and/or food cue-elicited craving assessed in a bar-like laboratory
* Whether semaglutide reduces and/or changes food choices in a virtual reality buffet-like laboratory
* Whether semaglutide reduces brain activation during a functional magnetic resonance imaging (fMRI) scan
This study will test the safety/tolerability and early efficacy of subcutaneous (s.c.) semaglutide at the dose of 2.4 mg/week or maximum tolerated dose (MTD) as a potential new treatment for alcohol use disorder (AUD).
Objectives:
We propose to test safety/tolerability and early efficacy of semaglutide, a glucagon-like peptide-1 (GLP-1) analogue, as a novel pharmacotherapy to reduce alcohol use and related measures. This will be a Phase 2a, pilot, proof-of-concept, outpatient study combined with experimental medicine human laboratory procedures.
Endpoints:
The co-primary aims will be to determine whether A) semaglutide is safe and tolerable in individuals with AUD, as measured by the frequency/severity of adverse events and the proportion of participants who reach maximum dose, and B) semaglutide reduces alcohol drinking from baseline to endpoint, as measured by total number of standard alcohol-containing drinks consumed per week (drinks per week, DPW).
The following secondary aims will also be examined:
* Whether semaglutide reduces other self-reported alcohol-related outcomes (e.g., heavy drinking days, drinks per drinking days, World Health Organization (WHO) drinking levels)
* Whether semaglutide reduces blood Phosphatidylethanol (PEth) levels as a biomarker of alcohol use
* Whether semaglutide reduces alcohol and/or food cue-elicited craving assessed in a bar-like laboratory
* Whether semaglutide reduces and/or changes food choices in a virtual reality buffet-like laboratory
* Whether semaglutide reduces brain activation during a functional magnetic resonance imaging (fMRI) scan
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 001603-DA | None | None | View |