Understanding how acamprosate affects brain function in alcohol use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of acamprosate on brain function in individuals with alcohol use disorder (AUD) through a double-blind, placebo-controlled design. Participants aged 21 to 65 will undergo a detoxification period followed by 21 days of treatment with either acamprosate or a placebo. The study will utilize electroencephalography (EEG) to measure changes in brain activity and correlate these changes with clinical outcomes such as anxiety and alcohol craving. The goal is to determine if acamprosate can normalize specific EEG markers associated with AUD.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Nancy Diazgranados, M.D. — National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Study coordinator: Beth A Lee, R.N.
• Email: beth.lee@nih.gov
• Phone: (301) 451-6964

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.