At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 150 enrolled
Drug / intervention
ABT-436 +1 moredrug
Likely dose
ABT-436 400mgfrom 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.
A Phase 2, Double-Blind, Randomized, Placebo Controlled Trial to Assess the Efficacy of ABT-436 for Alcohol Dependence
National Institute on Alcohol Abuse and Alcoholism (NIAAA)·interventional·Posted Jun 6, 2012·Updated Apr 4, 2017
In Brief
A Phase 2 clinical trial evaluating ABT-436 and Matched Placebo - Sugar Pill for Alcohol Dependence and 3 related conditions. Completed, enrolled 150 participants across 5 sites.
Detailed Summary
The primary efficacy endpoint examines the hypothesis that ABT-436 will decrease the weekly percentage of heavy drinking days during Study Weeks 2 through 12 (Days 8-84) as compared to placebo. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Dependence, Alcohol Abuse, Alcohol Use Disorders, Alcoholism
CountriesUnited States
CollaboratorsAbbVie
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartFeb 2013
Primary CompletionMay 2015
Study CompletionJul 2015
TodayJul 2026
First PostedJun 6, 2012
Enrollment StartFeb 1, 2013
Primary CompletionMay 1, 2015
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.1 years ago
Interventions
ABT-436drug
Target dose - 400mg BID
Matched Placebo - Sugar Pilldrug
Target Dose - 2 pills BID