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Extended Release Naltrexone for Opioid-Dependent Youth

NCT01843023 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2021-11-10

Study results available
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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).

Conditions

  • Drug Dependence

Interventions

DRUG

Extended Release Naltrexone

naltrexone for extended release injectable suspension

BEHAVIORAL

Psychosocial Treatment

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

DRUG

Buprenorphine

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.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Friends Research Institute, Inc.

    lead OTHER

Principal Investigators

  • Shannon G Mitchell, PhD · Friends Research Institute, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2018-01-31
Completion
2019-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01843023 on ClinicalTrials.gov