Actively Recruiting
Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder
Led by National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Updated on 2026-03-03
48
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 21 and 65 years
- Enrolled in NIAAA natural history protocol 14-AA-0181
- Admitted to NIAAA alcohol treatment program with moderate to severe alcohol use disorder
- Clinically stable enough to provide informed consent for research
- AUD severity confirmed by Structured Clinical Interview for DSM-5 after enrollment
You will not qualify if you...
- Use of naltrexone, disulfiram, benzodiazepines (except Oxazepam), antiepileptic compounds, antidepressants, neuroleptics, or acamprosate currently or within the last 4 weeks
- Pregnancy at admission (negative urine pregnancy test required)
- History of head trauma with unconsciousness lasting more than 30 minutes, lasting effects, or cranial surgery
- History of epilepsy
- History of non-substance related psychotic disorders
- Contraindications to acamprosate including hypersensitivity or severe renal impairment (creatinine clearance �30 mL/min)
- Positive alcohol or illicit drug screens (except THC) after admission and detoxification
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
B
Beth A Lee, R.N.
CONTACT
N
Nancy Diazgranados, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here