Recruiting

Acamprosate

Sponsor:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Code:

NCT06269627

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Acamprosate calcium

Placebo

Study Details

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.

Conditions

Alcohol Use Disorder

Study ID

NCT06269627

Start date

May 7, 2025

Status verified date

Aug 21, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

  • 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.

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, neuroleptics, or acamprosate within a time sufficient for the medication to be eliminated from the body (five half-lives from last use).
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 Glomerular Filtration Rate (GFR) <= 60 ml/min/1.73 m2).
7. Positive screens for alcohol or any illicit drugs (except THC) after admission and alcohol detoxification via breathanalysis and urine drug screen.

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Active

This arm has participants receiving acamprosate for 21 day as inpatients.

placebo comparator: Placebo

This arm has participants receiving placebo for 21 day as inpatients.

Interventions

Acamprosate calcium

Two oral capsules (packaged as one) containing 666 mg of acamprosate calcium will be given three times a day (total daily dose: 1998 mg/day) for a total of 21 days.

Placebo

Two oral capsules (packaged as one) containing 666 mg of inactive substance (e.g., sugar) will be given three times a day (total daily dose: 1998 mg/day) for a total of 21 days.

Primary outcome measure

  • Reduction of beta power [ Time Frame: 21 day period as inpatients ]

Central Contacts and Locations

Central contacts

Beth A Lee, R.N.

(301) 451-6964beth.lee@nih.gov

Nancy Diazgranados, M.D.

(301) 496-7515nancy.diazgranados@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Last update posted

Sep 3, 2026

Last verified

Aug 21, 2026

Keywords

  • Multimodal
  • Neuroscience
  • Resting State
  • Event-Related Potentials
  • Artificial Intelligence
  • Machine Learning
  • ELECTROENCEPHALOGRAPHY
  • Acamprosate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute on Alcohol Abuse and Alcoholism (NIAAA) on 2026-09-03.