At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 346 enrolled
Drug / intervention
gabapentin enacarbil +1 moredrug
Likely dose
gabapentin enacarbil 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
National Institute on Alcohol Abuse and Alcoholism (NIAAA)·interventional·Posted Sep 30, 2014·Updated Nov 14, 2018
In Brief
A Phase 2 clinical trial evaluating gabapentin enacarbil and Placebo for Alcohol Use Disorder. Completed, enrolled 346 participants across 10 sites.
Detailed Summary
The purpose of this study is to determine whether gabapentin enacarbil is effective in the treatment of problems with alcohol.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Use Disorder
CountriesUnited States
CollaboratorsArbor Pharmaceuticals, Inc.
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 2014
Enrollment StartJun 2015
Primary CompletionMar 2017
TodayJul 2026
First PostedSep 30, 2014
Enrollment StartJun 1, 2015
Primary CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.8 years ago
Interventions
gabapentin enacarbildrug
Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day
Placebodrug
Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day