At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 80 enrolled
Drug / intervention
VIVITROL (Naltrexone extended-release injectable suspension) +1 moredrug
Likely dose
VIVITROL (Naltrexone extended-release injectable suspension) 380 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.
A Phase II, Randomized, Double-Blind Pilot Trial of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension) for the Treatment of Cocaine and Alcohol Dependence
In Brief
A Phase 2 clinical trial evaluating VIVITROL (Naltrexone extended-release injectable suspension) and Placebo for Cocaine Dependence and Alcohol Dependence. Completed, enrolled 80 participants across 1 site.
Detailed Summary
To evaluate the efficacy of VIVITROL (naltrexone for extended-release injectable suspension) for the treatment of co-occurring cocaine and alcohol dependence
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCocaine Dependence, Alcohol Dependence
CountriesUnited States
CollaboratorsAlkermes, Inc., National Institute on Drug Abuse (NIDA)
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2008
Enrollment StartJul 2009
Primary CompletionJul 2012
Study CompletionSep 2013
TodayJul 2026
First PostedOct 22, 2008
Enrollment StartJul 1, 2009
Primary CompletionJul 1, 2012
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 17.7 years ago
Interventions
VIVITROL (Naltrexone extended-release injectable suspension)drug
VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6.
Placebodrug
Placebo injection at the start of weeks 2 and 6.