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Taking people in United StatesPhase 4

Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder

Key facts

Who runs it
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Where
Bethesda, United StatesSee the site
Trial code
Status
Recruiting
Phase
Phase 4
People taking part
48 people, planned
Started
7 May 2025
Expected to end
31 Dec 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Acamprosate calcium
  • Placebo
Record updated
2 November 2026

Who can take part

Age
21 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who cannot take part

  • 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)
  • Positive screens for alcohol or any illicit drugs (except THC) after admission and alcohol detoxification via breathanalysis and urine drug screen
  • History of head trauma associated with an unconscious state lasting more than 30 minutes, persistent sequelae, and/or cranial surgery
  • History of epilepsy
  • History of non-substance related psychotic disorders
  • 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)
  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Pregnancy at admission (negative urine pregnancy test required)

Other criteria

  • INCLUSION CRITERIA:; In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • 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
  • Enrolled in NIAAA natural history protocol 14-AA-0181
  • Admitted to alcohol treatment program of NIAAA with moderate to severe alcohol use disorder by a clinician at the time of admission
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 21 and 65 years old?

Where in United States

  • National Institutes of Health Clinical CenterBethesda, United StatesContact: NIH Clinical Center Office of Patient Recruitment (OPR)Taking people

About the trial

What the trial wants to find out

Background:

Read full original descriptionShow less

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.

The 2 groups in the trial

  • ActiveExisting treatment, for comparison

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

    Treatment: Acamprosate calcium

  • PlaceboPlacebo, for comparison

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Fit questions
Built from NCT06269627, who can take part
Record updated
2 November 2026