Buprenorphine/Naloxone - Facilitated Rehabilitation for Opioid Dependent Adolescents - 1

January 11, 2017 updated by: University of Pennsylvania

Bup/Nx - Facilitated Rehab for Opioid Dependent Adolescents

The purpose of this study is to compare two 3-month treatments for adolescents/young adults who are addicted to heroin: buprenorphine/naloxone combined with psychosocial therapy and treatment as usual, a 7-14 day detoxification with buprenorphine and three weeks of psychosocial therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

223

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maine
      • Portland, Maine, United States, 04092
        • Mercy Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Mountain Manor
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • ASAP
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Addictions Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Male and non-pregnant female subjects seeking outpatient treatment for opioid dependence with physiological features without serious medical or psychiatric disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Opiate abstinence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: George Woody, M.D., University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

February 19, 2004

First Submitted That Met QC Criteria

February 19, 2004

First Posted (Estimate)

February 20, 2004

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-CTN-0010-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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