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Semaglutide Therapy for Alcohol Reduction (STAR)

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 21% 80 → 63 participants
See other at-risk trials from National Institute on Drug Abuse (NIDA)

Record History

The 50 most recent of 293 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. 3 versions Re-verified since Jul 31, 2026, no change to tracked fieldsv291-v293
  2. Primary and study completion moved earlier from Dec 31, 2030 to Mar 31, 2027 Enrollment closed, study ongoing · Enrollment reduced: 80 → 63 participants · Site details revisedv290 Show 3 more changesShow less
    • Enrollment closed, study ongoing
    • Enrollment reduced: 80 → 63 participants
    • Site details revised
  3. 4 versions Re-verified since May 9, 2026, no change to tracked fieldsv286-v289
  4. Primary endpoint(s) modified Enrollment increased: 67 → 80 participantsv285 Show 1 more changeShow less
    • Enrollment increased: 67 → 80 participants

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv284
  6. Study Status, Study Description, Outcome Measuresv283
  7. Enrollment increased: 52 → 67 participantsv282
  8. 3 versions Re-verified since Dec 2, 2025, no change to tracked fieldsv279-v281
  9. Study Status, Contacts/Locationsv278
  10. 7 versions Re-verified since Apr 3, 2025, no change to tracked fieldsv271-v277
  11. Eligibility criteria revisedv270 See this version in full on ClinicalTrials.gov ↗
  12. Study Status, Eligibilityv269
  13. Start date changed from estimate of Feb 19, 2025 to Oct 17, 2023v268
  14. Start date: Feb 18, 2025 to Feb 19, 2025v267
  15. Start date: Feb 17, 2025 to Feb 18, 2025v266
  16. Start date: Feb 16, 2025 to Feb 17, 2025v265
  17. Start date: Feb 13, 2025 to Feb 16, 2025v264
  18. Start date: Feb 12, 2025 to Feb 13, 2025v263
  19. Start date: Feb 11, 2025 to Feb 12, 2025v262
  20. Start date: Feb 10, 2025 to Feb 11, 2025v261
  21. Start date: Feb 9, 2025 to Feb 10, 2025v260
  22. Start date: Feb 6, 2025 to Feb 9, 2025v259
  23. Start date: Feb 5, 2025 to Feb 6, 2025v258
  24. Start date: Feb 4, 2025 to Feb 5, 2025v257
  25. Start date: Feb 3, 2025 to Feb 4, 2025v256
  26. Start date: Feb 2, 2025 to Feb 3, 2025v255
  27. Start date: Jan 30, 2025 to Feb 2, 2025v254
  28. Start date: Jan 29, 2025 to Jan 30, 2025v253
  29. Start date: Jan 28, 2025 to Jan 29, 2025v252
  30. Start date: Jan 27, 2025 to Jan 28, 2025v251
  31. Start date: Jan 22, 2025 to Jan 27, 2025v250
  32. Start date: Jan 21, 2025 to Jan 22, 2025v249
  33. Start date: Jan 20, 2025 to Jan 21, 2025v248
  34. Start date: Jan 19, 2025 to Jan 20, 2025v247
  35. Start date: Jan 16, 2025 to Jan 19, 2025v246
  36. Start date: Jan 15, 2025 to Jan 16, 2025v245
  37. Start date: Jan 14, 2025 to Jan 15, 2025v244
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06015893
Lead Sponsor National Institute on Drug Abuse (NIDA)
Conditions Addiction, Alcohol Use Disorder
Enrollment 63 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov