CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 306 enrolled
Drug / intervention
naltrexone implant +3 moredrug
Likely dose
Naltrexone implant 1000 mg or oral naltrexone 50 mg/dayAI-extracted
Key inclusion· 2
  • Current opioid dependence
  • Recently completed opioid detoxification
Key exclusion· 4
  • Serious medical or psychiatric condition requiring immediate hospitalization or that would make participation hazardous
  • Planning to leave the study area within 12 months of entry
  • Imminent incarceration
  • Pregnancy

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

Search/NCT00218426
NCT00218426Phase 3Completed

Addiction Treatment in Russia: Oral and Depot Naltrexone

University of Pennsylvania·interventional·Posted Sep 22, 2005·Updated Mar 18, 2019

In Brief

A Phase 3 clinical trial evaluating naltrexone implant, oral naltrexone, and 2 other interventions for Heroin Dependence and Opioid-Related Disorders. Completed, enrolled 306 participants across 2 sites in 2 countries.

Detailed Summary

Heroin addiction is a growing problem in Russia; individuals who enter heroin addiction treatment often relapse. Therefore, effective heroin addiction treatments are necessary to prevent relapse. The purpose of this study is to compare oral naltrexone with a naltrexone implant that provides opioid blockade for two months in preventing relapse to heroin addiction in St. Petersburg, Russia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesRussia, United States

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartJul 1, 2006
Primary CompletionJun 1, 2009
Study CompletionNov 4, 2010
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 20.8 years ago

Interventions

naltrexone implantdrug

naltrexone implant is 1000 mg naltrexone

oral naltrexonedrug

oral naltrexone 50 mg/day

oral placebo naltrexonedrug

oral placebo naltrexone resembles active medication

placebo implantdrug

placebo implant resembles active medication