NCT01843023

Extended Release Naltrexone for Opioid-Dependent Youth

Health Services Research: Extended Release Naltrexone for Opioid-Dependent Youth

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 288 (actual)
• Sponsor: Friends Research Institute, Inc. · Academic / Other
• Sex: All
• Age: 15 Years – 21 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This proposed study is a 6-month, two-group randomized clinical trial of XR-NTX v. TAU for 340 opioid-dependent youth ages 15-21. The study will be conducted at Mountain Manor Treatment Center, a community drug treatment program in Baltimore. TAU will consist of buprenorphine treatment of opioid withdrawal followed by counseling with or without continued buprenorphine.

Conditions

• Drug Dependence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-06-01
• Primary completion: 2018-01-31
• Completion: 2019-07-01
• First posted: 2013-04-30
• Last updated: 2021-11-10
• Results posted: 2021-11-10

Locations

2 sites across 1 country: United States