CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 100 enrolled
Drug / intervention
VIVITROL injection and VIVITROL Placebo Injection , 24 weeksdrug
Likely dose
Not stated in 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/NCT01100853
NCT01100853Phase 3Completed

Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland

University of Pennsylvania·interventional·Posted Apr 9, 2010·Updated Mar 6, 2018

In Brief

A Phase 3 clinical trial evaluating VIVITROL injection and VIVITROL Placebo Injection , 24 weeks for Amphetamine Dependence. Completed, enrolled 100 participants across 1 site.

Detailed Summary

Until positive results were found with oral naltrexone, no medication has been effective against amphetamine dependence. The primary aim of this pilot study is to replicate the findings of the Swedish team that showed oral Naltrexone prevented relapse to amphetamine addiction and to extend their results by randomizing treatment-seeking amphetamine addicted patients to a 6 month course of VIVITROL (naltrexone for extended-release injectable suspension) or VIVITROL placebo. Patients in each group will receive drug counseling. VIVITROL is administered monthly and may be a better test of efficacy than tablets that must be taken daily.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIceland

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 9, 2010
Enrollment StartMay 1, 2010
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 16.2 years ago

Interventions

VIVITROL injection and VIVITROL Placebo Injection , 24 weeksdrug

Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)