RECRUITING

Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder

Quick Facts

Study Start:2025-05-07
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06269627

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Enrolled in NIAAA natural history protocol 14-AA-0181.
  3. 3. Stated willingness to comply with all required study procedures and availability for the duration of the study.
  4. 4. Diagnosed with moderate to severe alcohol use disorder by a clinician at the time of admission.
  5. 5. Agreement to adhere to Lifestyle Considerations (see below) throughout study duration.
  1. 1. Use of naltrexone, disulfiram, benzodiazepines (except Oxazepam), antiepileptic compounds, antidepressants, or neuroleptics currently or within the last 4 weeks.
  2. 2. Pregnancy at admission (negative urine pregnancy test required).
  3. 3. History of head trauma associated with an unconscious state lasting more than 30 minutes, persistent sequelae, and/or cranial surgery.
  4. 4. History of epilepsy.
  5. 5. History of non-substance related psychotic disorders.
  6. 6. 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).
  7. 7. Positive screens for alcohol or any illicit drugs (except THC) after admission and alcohol detoxification via breathanalysis and urine drug screen.
  8. 8. Current Clinical Institute Withdrawal Assessment (CIWA-Ar) score greater than or equal to 8. The participant can enroll in the study once their CIWA-Ar score drops below 8.

Contacts and Locations

Study Contact

Beth A Lee, R.N.
CONTACT
(301) 451-6964
beth.lee@nih.gov
Reza Momenan, Ph.D.
CONTACT
(301) 451-6972
rezam@nih.gov

Principal Investigator

Reza Momenan, Ph.D.
PRINCIPAL_INVESTIGATOR
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

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

  • Reza Momenan, Ph.D., PRINCIPAL_INVESTIGATOR, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-07
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-05-07
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Alcohol Use Disorder