CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 288 enrolled
Drug / intervention
Extended Release Naltrexone +2 moredrug
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/NCT01843023
NCT01843023Phase 4Completed
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Health Services Research: Extended Release Naltrexone for Opioid-Dependent Youth

Friends Research Institute, Inc.·interventional·Posted Apr 30, 2013·Updated Nov 10, 2021

In Brief

A Phase 4 clinical trial evaluating Extended Release Naltrexone, Psychosocial Treatment, and 1 other intervention for Drug Dependence. Completed, enrolled 288 participants across 2 sites.

Detailed Summary

The purpose of this study is to compare 6-month treatment outcomes for 15-21 year old opioid-dependent youth receiving extended release naltrexone (XR-NTX) v. Treatment as Usual (TAU).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDrug Dependence
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 30, 2013
Enrollment StartJun 1, 2013
Primary CompletionJan 31, 2018
Study CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 13.2 years ago

Interventions

Extended Release Naltrexonedrug

naltrexone for extended release injectable suspension

Psychosocial Treatmentbehavioral

Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.

Buprenorphinedrug

Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study.