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Actively Recruiting

Phase 4
Age: 21Years - 65Years
All Genders
ID06269627

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

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to study how acamprosate affects brain function in people aged 21 to 65 years with moderate to severe alcohol use disorder AUD. The study focuses on changes in brain electrical activity, anxiety, and alcohol craving during and after treatment. It is a double-blind, placebo-controlled trial investigating whether acamprosate normalizes specific brain wave patterns compared to placebo. Participants will stay in a clinic for 21 days following about 7 days of detoxification. They will take either acamprosate capsules or placebo capsules three times a day with meals during this inpatient period. The study involves two main groups one receiving acamprosate and the other receiving placebo, both under blinded conditions. Additional optional EEG and sleep studies may be done, and participants may have up to three follow-up visits over six months. During the study, participants will undergo EEG tests on day 2 and day 23, where brain electrical activity is recorded while performing tasks involving visual shapes and tones. Some may also have extra EEGs and sleep studies. Researchers will assess changes in brain wave patterns, anxiety, and craving. Safety and clinical status will be monitored, with the study lasting several months including follow-up visits to observe longer-term effects.

CONDITIONS

Brief Title

Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder

Who Can Participate

Age: 21Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21 to 65 years
  • Enrolled in NIAAA natural history protocol 14-AA-0181
  • Diagnosed with moderate to severe alcohol use disorder by a clinician at admission
  • Clinically stable enough to provide informed consent for research
Not Eligible

You will not qualify if you...

  • Use of naltrexone, disulfiram, benzodiazepines (except Oxazepam), antiepileptic drugs, antidepressants, neuroleptics, or acamprosate within the last 4 weeks
  • Pregnancy at admission (negative urine pregnancy test required)
  • History of head trauma with unconsciousness over 30 minutes, persistent 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 via breath and urine tests

Research Team

B

Beth A Lee, R.N.

N

Nancy Diazgranados, M.D.

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