Randomized, Double Blind, Placebo-Controlled Trial of the Safety and Efficacy of HORIZANT® (Gabapentin Enacarbil) Extended-Release Tablets for the Treatment of Alcohol Use Disorder

Randomized, Double Blind, Placebo-Controlled Trial of the Safety and Efficacy of HORIZANT® (Gabapentin Enacarbil) Extended-Release Tablets for the Treatment of Alcohol Use Disorder
Recruiting
21 years - 100 years
All
Phase 2
1 Location

Brief description of study

Alternating phone and in-clinic visits for medical management (MM), laboratory tests, and physical exams, to assess drug compliance, to complete additional questionnaires, and to provide counseling (via “Take Control” videos) over 29 weeks.

Detailed description of study

The primary objective of the study is to compare the efficacy of HORIZANT (gabapentin enacarbil) Extended-Release Tablets 600 mg twice daily (BID) with matched placebo on the primary alcohol consumption outcome endpoint, percentage of subjects with no heavy drinking days (PSNHDD) during the last 4 weeks of treatment, among patients with Alcohol Use Disorder (AUD).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Alcoholic Intoxication, Alcoholism, Addictive Behavior, medication, Alcohol Use Disorder, Alcohol-Related Disorders
  • Age: 21 years - 100 years
  • Gender: All
Updated on 19 Feb 2024. Study ID: 821946

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