CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 48 enrolled
Drug / intervention
Extended-Release Naltrexone +1 moredrug
Likely dose
Extended-Release Naltrexone 380mgfrom 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/NCT01180647
NCT01180647Phase 3Completed
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Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail

NYU Langone Health·interventional·Posted Aug 12, 2010·Updated Apr 7, 2016

In Brief

A Phase 3 clinical trial evaluating Extended-Release Naltrexone and Motivational Enhancement Counseling for Opiate Dependence. Completed, enrolled 48 participants across 2 sites.

Detailed Summary

This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as self-reported opioid use \>50% (\>15 of 30) of days during the first 30 days following release from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpiate Dependence
CountriesUnited States
CollaboratorsAlkermes, Inc., New York City Department of Health and Mental Hygiene

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 12, 2010
Enrollment StartMay 1, 2010
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 15.9 years ago

Interventions

Extended-Release Naltrexonedrug

380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).

Motivational Enhancement Counselingbehavioral

The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.