CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 300 enrolled
Drug / intervention
VIVITROL 380 mg +1 moredrug
Likely dose
VIVITROL 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.

Search/NCT00501631
NCT00501631Phase 3Completed
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Efficacy and Safety of VIVITROL® in Adults Completing Inpatient Treatment for Alcohol Dependence

Alkermes, Inc.·interventional·Posted Jul 16, 2007·Updated Sep 22, 2011

In Brief

A Phase 3 clinical trial evaluating VIVITROL 380 mg and Placebo for VIVITROL 380 mg for Alcohol Dependence. Completed, enrolled 300 participants.

Detailed Summary

VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. This Phase 3B trial was designed to evaluate the efficacy and safety of VIVITROL versus placebo. Injections were administered to patients in whom abstinence was enforced by a period of inpatient hospitalization of 7 to 21 days.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Dependence
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 16, 2007
Enrollment StartJul 1, 2007
Primary CompletionJan 1, 2011
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 19.0 years ago

Interventions

VIVITROL 380 mgdrug

Administered via IM injection once every 4 weeks.

Placebo for VIVITROL 380 mgdrug

Administered via IM injection once every 4 weeks.