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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: Recruiting Phase 4 study of Alcohol Use Disorder, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Spectral power of EEG signals will be calculated in the beta frequency band (beta power). We expect a reduction of beta power to be greater in participants receiving acamprosate for 21 days than participants receiving placebo.
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 |
What NCT06269627 shows while recruiting
NCT06269627 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (85% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Alcohol Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06269627's enrollment target sits among peer trials
48 129th of 184 higher than 55 of 184 other Alcohol Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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