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

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Updated on 19 February 2024

Summary

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.

Description

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).

Details
Condition Alcoholic Intoxication, Alcoholism, Addictive Behavior, medication, Alcohol Use Disorder, Alcohol-Related Disorders
Age 21years - 100years
Clinical Study IdentifierNCT02252536
Last Modified on19 February 2024

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