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

This study has been completed.
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
First received: February 19, 2004
Last updated: April 13, 2010
Last verified: April 2010
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.

Condition Intervention Phase
Opioid-Related Disorders
Drug: Buprenorphine/naloxone
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Bup/Nx - Facilitated Rehab for Opioid Dependent Adolescents

Resource links provided by NLM:

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Opiate abstinence

Estimated Enrollment: 223
Study Start Date: July 2003
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   14 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Male and non-pregnant female subjects seeking outpatient treatment for opioid dependence with physiological features without serious medical or psychiatric disorders.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00078130

United States, Maine
Mercy Hospital
Portland, Maine, United States, 04092
United States, Maryland
Mountain Manor
Baltimore, Maryland, United States, 21229
United States, New Mexico
Albuquerque, New Mexico, United States, 87106
United States, North Carolina
Duke Addictions Program
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
University of Pennsylvania
Principal Investigator: George Woody, M.D. University of Pennsylvania
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: George Woody, M.D., University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00078130     History of Changes
Other Study ID Numbers: NIDA-CTN-0010-1 
Study First Received: February 19, 2004
Last Updated: April 13, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Buprenorphine, Naloxone Drug Combination
Analgesics, Opioid
Central Nervous System Depressants
Narcotic Antagonists
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 23, 2016