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NCT06015893 · ClinicalTrials.gov registry record · Phase 2
Semaglutide Therapy for Alcohol Reduction (STAR)
A Phase 2 study of Alcohol Use Disorder and Addiction, sponsored by National Institute on Drug Abuse (NIDA).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT06015893 is a Phase 2 study of Alcohol Use Disorder and Addiction that is actively recruiting participants, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 52 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06015893, a Phase 2 study of Alcohol Use Disorder and Addiction, is actively recruiting participants, sponsored by National Institute on Drug Abuse (NIDA).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
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 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.
Conditions Studied
Interventions
- DRUG Semaglutide
- BEHAVIORAL Take Control
Study Locations (1)
Maryland
- National Institute on Drug Abuse - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2023-10-17 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06015893
The ClinicalTrials.gov registry entry for NCT06015893 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (84% lower). The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Alcohol Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Semaglutide is the first listed.
NCT06015893 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06015893 about?
NCT06015893 is a clinical study titled "Semaglutide Therapy for Alcohol Reduction (STAR)". 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 medica...
What is the current status of trial NCT06015893?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2023-10-17. Estimated completion is 2030-12-31.
What conditions does trial NCT06015893 study?
This clinical trial studies the following conditions: Alcohol Use Disorder, Addiction.
What interventions are being tested in trial NCT06015893?
The interventions under investigation include: Semaglutide (DRUG), Take Control (BEHAVIORAL).
Who is sponsoring clinical trial NCT06015893?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06015893 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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