Understanding how acamprosate affects brain function in alcohol use disorder
Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder
This study is testing whether acamprosate can improve brain function and reduce anxiety and cravings in people with alcohol use disorder.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06269627 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21 to 65 with moderate to severe alcohol use disorder.
Not a fit: Patients currently using certain medications like naltrexone or benzodiazepines may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for individuals with alcohol use disorder by enhancing understanding of how acamprosate affects brain function.
How similar studies have performed: While there have been studies on acamprosate, this specific approach using EEG to assess brain function changes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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. * The determination of the severity of AUD is via Structured Clinical Interview for DSM-5 after particpant s enrollment. 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, or neuroleptics currently or within the last 4 weeks. Individuals treated with acamprosate in the last 4 weeks would also be excluded. 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 creatinine clearance \<= 30 mL/min). 7. Positive screens for alcohol or any illicit drugs (except THC) after admission and alcohol detoxification via breathanalysis and urine drug screen.
Where this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.