RecruitingPHASE4NCT06269627

Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder

Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Trial Details

ConditionAlcohol Use Disorder
InterventionAcamprosate calcium; Placebo
PhasePHASE4
StatusRecruiting
Participants48
Est. Completion31 Dec 2026
Last Updated22 July 2026

Primary Outcome

Reduction of beta power

Eligibility Criteria

Inclusion 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. 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.

Trial Sites

Countries

United States
View Registry Entry

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