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Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 275 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor 2 versions Re-verified since Jul 21, 2026, no change to tracked fieldsv274-v275
  2. Minor Eligibility criteria shortened, about 17 wordsv273
  3. Minor Re-verified, no change to tracked fieldsv272
  4. Notable Primary completion date: Dec 31, 2025 to Dec 31, 2026v271
  5. Minor 5 versions Re-verified since Sep 3, 2025, no change to tracked fieldsv266-v270
Show 40 earlier versionsHide 40 earlier versions
  1. Minor Eligibility criteria expanded, about 1 wordv265
  2. Minor 3 versions Re-verified since May 30, 2025, no change to tracked fieldsv262-v264
  3. Minor Eligibility criteria shortened, about 4 wordsv261
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 14, 2025 to May 7, 2025
    v260
  5. Minor Start date: May 13, 2025 to May 14, 2025v259
  6. Minor Start date: May 12, 2025 to May 13, 2025v258
  7. Minor Start date: May 11, 2025 to May 12, 2025v257
  8. Minor Start date: May 8, 2025 to May 11, 2025v256
  9. Minor Start date: May 7, 2025 to May 8, 2025v255
  10. Minor Start date: May 6, 2025 to May 7, 2025v254
  11. Minor Start date: May 5, 2025 to May 6, 2025v253
  12. Minor Start date: May 4, 2025 to May 5, 2025v252
  13. Minor Start date: May 1, 2025 to May 4, 2025v251
  14. Minor Start date: Apr 30, 2025 to May 1, 2025v250
  15. Minor Start date: Apr 29, 2025 to Apr 30, 2025v249
  16. Minor Start date: Apr 28, 2025 to Apr 29, 2025v248
  17. Minor Start date: Apr 27, 2025 to Apr 28, 2025v247
  18. Minor Start date: Apr 24, 2025 to Apr 27, 2025v246
  19. Minor Start date: Apr 23, 2025 to Apr 24, 2025v245
  20. Minor Start date: Apr 22, 2025 to Apr 23, 2025v244
  21. Minor Start date: Apr 21, 2025 to Apr 22, 2025v243
  22. Minor Start date: Apr 20, 2025 to Apr 21, 2025v242
  23. Minor Start date: Apr 16, 2025 to Apr 20, 2025v241
  24. Minor Start date: Apr 15, 2025 to Apr 16, 2025v240
  25. Minor Start date: Apr 13, 2025 to Apr 15, 2025v239
  26. Minor Start date: Apr 10, 2025 to Apr 13, 2025v238
  27. Minor Start date: Apr 9, 2025 to Apr 10, 2025v237
  28. Minor Start date: Apr 8, 2025 to Apr 9, 2025v236
  29. Minor Start date: Apr 7, 2025 to Apr 8, 2025v235
  30. Minor Start date: Apr 4, 2025 to Apr 7, 2025v234
  31. Minor Start date: Apr 3, 2025 to Apr 4, 2025v233
  32. Minor Start date: Apr 1, 2025 to Apr 3, 2025v232
  33. Minor Start date: Mar 31, 2025 to Apr 1, 2025v231
  34. Minor Start date: Mar 30, 2025 to Mar 31, 2025v230
  35. Minor Start date: Mar 27, 2025 to Mar 30, 2025v229
  36. Minor Start date: Mar 26, 2025 to Mar 27, 2025v228
  37. Minor Start date: Mar 25, 2025 to Mar 26, 2025v227
  38. Minor Start date: Mar 24, 2025 to Mar 25, 2025v226
  • 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: Chronic heavy drinking can cause alcohol use disorder (AUD). AUD changes how the brain works. People with AUD may drink compulsively or feel like they cannot control their alcohol use. Acamprosate is an FDA-approved drug that reduces anxiety and craving in some, but not all, people with AUD. Objective: To learn more about how acamprosate affects brain function in people with AUD. Eligibility: People aged 21 to 65 years with moderate to severe AUD. Design: Participants will stay in the clinic for 21 days after a detoxification period of approximately 7 days. Acamprosate is a capsule taken by mouth. Half of participants will take this drug 3 times a day with meals. The other half will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which capsules they are taking. Participants will have a procedure called electroencephalography (EEG): A gel will be applied to certain locations on their scalp, and a snug cap will be placed on their head. The cap has sensors with wires. The sensors detect electrical activity in the brain. Participants will lie still and perform 2 tasks: they will look at different shapes and press a button when they see a specific one; and they will listen to tones and press dedicated buttons when they hear the corresponding tones. Participants will have 2 EEGs: 1 on day 2 and 1 on day 23 of their study participation. They may opt to have up to 4 more EEG studies (one on day 13 and one on each of the three follow-up visits) and 2 sleep studies, in which they would have sensors attached to their scalp while they sleep. Participants may have up to three follow-up visits for 6 months.
Trial Details
NCT Number NCT06269627
Lead Sponsor National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions
(from sponsor)
Alcohol Use Disorder
Related terms Alcoholism
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov