NCT06269627 Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder
| NCT ID | NCT06269627 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-05-07 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 48 participants in total. It began in 2025-05-07 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Age 21-65. In younger participants, the central nervous system has not sufficiently developed, whereas in older participants, degenerative changes may confound the studied measures. Moreover, the minimum legal drinking age is 21 years. 2. Enrolled in NIAAA natural history protocol 14-AA-0181. 3. Admitted to alcohol treatment program of NIAAA\* with moderate to severe alcohol use disorder by a clinician at the time of admission. 4. Determination by the attending physician or licensed practitioner caring for the patient that the patient s current clinical status is stable enough to provide informed consent for research. * The determination of the severity of AUD is via Structured Clinical Interview for DSM-5 after particpant s enrollment. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Use of naltrexone, disulfiram, benzodiazepines (except Oxazepam), antiepileptic compounds, antidepressants, or neuroleptics currently or within the last 4 weeks. Individuals treated with acamprosate in the last 4 weeks would also be excluded. 2. Pregnancy at admission (negative urine pregnancy test required). 3. History of head trauma associated with an unconscious state lasting more than 30 minutes, persistent sequelae, and/or cranial surgery. 4. History of epilepsy. 5. History of non-substance related psychotic disorders. 6. Contraindications for acamprosate (previously exhibited hypersensitivity to acamprosate calcium or any of its compounds; and/or severe renal impairment, manifested as creatinine clearance \<= 30 mL/min). 7. Positive screens for alcohol or any illicit drugs (except THC) after admission and alcohol detoxification via breathanalysis and urine drug screen.
Contact & Investigator
Nancy Diazgranados, M.D.
PRINCIPAL INVESTIGATOR
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Frequently Asked Questions
Who can join the NCT06269627 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 65 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06269627 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06269627 currently recruiting?
Yes, NCT06269627 is actively recruiting participants. Contact the research team at beth.lee@nih.gov for enrollment information.
Where is the NCT06269627 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT06269627 clinical trial?
NCT06269627 is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The principal investigator is Nancy Diazgranados, M.D. at National Institute on Alcohol Abuse and Alcoholism (NIAAA). The trial plans to enroll 48 participants.