protocolSection identificationModule nctId: NCT06269627, orgStudyIdInfo id: 10001644, secondaryIdInfos id: 001644-AA, briefTitle: Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Institute on Alcohol Abuse and Alcoholism (NIAAA), class: NIH, descriptionModule briefSummary: 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., conditionsModule conditions: Alcohol Use Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Acamprosate calcium, interventions name: Placebo, outcomesModule primaryOutcomes measure: Reduction of beta power, secondaryOutcomes measure: Promotion of alpha power in active group compared to placebo group., secondaryOutcomes measure: No change in slow band (delta and theta) power in active group compared to placebo group., secondaryOutcomes measure: Reduction of theta event-related synchronization in active group compared to placebo group., secondaryOutcomes measure: Amplification and hastening of P300 in active group compared to placebo group., secondaryOutcomes measure: Correlation of EEG markers of acamprosate treatment with clinical measures of anxiety and alcohol craving, secondaryOutcomes measure: Correlation of EEG markers of acamprosate treatment with polysomnography markers, secondaryOutcomes measure: Correlation of polysomnography markers of acamprosate treatment with clinical measures of anxiety and alcohol craving, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Institutes of Health Clinical Center, city: Bethesda, state: Maryland, zip: 20892, country: United States, contacts name: NIH Clinical Center Office of Patient Recruitment (OPR), role: CONTACT, phone: 800-411-1222, phoneExt: TTY dial 711, email: ccopr@nih.gov, geoPoint lat: 38.98067, lon: -77.10026, hasResults: False