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NCT06269627 · ClinicalTrials.gov registry record · Phase 4
Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder
A Phase 4 study of Alcohol Use Disorder, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Recruiting
- Registry status
- Phase 4
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT06269627 is a Phase 4 study of Alcohol Use Disorder that is actively recruiting participants, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 48 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06269627, a Phase 4 study of Alcohol Use Disorder, is actively recruiting participants, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Acamprosate calcium
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2025-05-07 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06269627
The ClinicalTrials.gov registry entry for NCT06269627 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 48 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 (85% lower). The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alcohol Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06269627 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06269627 about?
NCT06269627 is a clinical study titled "Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder". 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...
What is the current status of trial NCT06269627?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 48 participants. The study started on 2025-05-07. Estimated completion is 2026-12-31.
What conditions does trial NCT06269627 study?
This clinical trial studies the following conditions: Alcohol Use Disorder.
What interventions are being tested in trial NCT06269627?
The interventions under investigation include: Placebo (OTHER), Acamprosate calcium (DRUG).
Who is sponsoring clinical trial NCT06269627?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06269627 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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