CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 38 enrolled
Drug / intervention
Medisorb naltrexone 380 mgdrug
Likely dose
Naltrexone 380 mg intramuscular injection once every 4 weeksAI-extracted
Key inclusion· 3
  • ✓Healthcare professional (physician, osteopath, nurse, pharmacist, etc.)
  • ✓Age 18 or older
  • ✓Enrolled or enrolling in extended outpatient treatment program for opioid dependence
Key exclusion· 7
  • ✕Pregnancy or lactation
  • ✕Evidence of hepatic failure
  • ✕Active hepatitis
  • ✕Psychiatric disorder that would compromise ability to complete study requirements

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00834080
NCT00834080Phase 3Completed
CompareCT.gov

Open-Label Study of the Safety and Tolerability of VIVITROL Administered to Health Care Professionals Participating in an Extended Outpatient Treatment Program for Opioid Dependence

Alkermes, Inc.·interventional·Posted Feb 3, 2009·Updated Dec 11, 2018

In Brief

A Phase 3 clinical trial evaluating Medisorb naltrexone 380 mg for Opiate Dependence. Completed, enrolled 38 participants across 11 sites.

Detailed Summary

The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone (VIVITROL®) when administered over a period of 24 months to health care professionals who have a history of opioid dependence.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpiate Dependence
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 3, 2009
Enrollment StartMar 1, 2009
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 17.4 years ago

Interventions

Medisorb naltrexone 380 mgdrug

Intramuscular (IM) injection administered once every 4 weeks for up to 2 years