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
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 Study 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).