Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder

NCT06269627 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: 10001644001644-AA
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Reduction of beta power

  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.

  21 day period as inpatients

Secondary Outcomes (7)

• Promotion of alpha power in active group compared to placebo group.

  21 day period as inpatients

• No change in slow band (delta and theta) power in active group compared to placebo group.

  21 day period as inpatients

• Reduction of theta event-related synchronization in active group compared to placebo group.

  21 day period as inpatients

• Amplification and hastening of P300 in active group compared to placebo group.

  21 day period as inpatients

• Correlation of EEG markers of acamprosate treatment with clinical measures of anxiety and alcohol craving

  21 day period as inpatients

Study Arms (2)

Active

ACTIVE COMPARATOR

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

Drug: Acamprosate calcium

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Acamprosate calcium DRUG

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.

Active

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The determination of the severity of AUD is via Structured Clinical Interview for DSM-5 after particpant s enrollment.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• 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.
• Pregnancy at admission (negative urine pregnancy test required).
• 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 creatinine clearance \<= 30 mL/min).
• Positive screens for alcohol or any illicit drugs (except THC) after admission and alcohol detoxification via breathanalysis and urine drug screen.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

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Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Alcoholism

Interventions

Acamprosate

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Taurine; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Nancy Diazgranados, M.D.

  National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth A Lee, R.N.

CONTACT

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

Nancy Diazgranados, M.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2024
• First Posted: February 21, 2024
• Study Start: May 7, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02-27

Locations

US (1)