Buprenorphine/Naloxone - Facilitated Rehabilitation for Opioid Dependent Adolescents - 1 - Full Text View

Purpose

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:

MedlinePlus related topics: Rehabilitation

Drug Information available for: Naloxone hydrochloride Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

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)

Eligibility

Ages Eligible for Study:	14 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078130

Locations

United States, Maine
Mercy Hospital
Portland, Maine, United States, 04092
United States, Maryland
Mountain Manor
Baltimore, Maryland, United States, 21229
United States, New Mexico
ASAP
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

Investigators

Principal Investigator:

George Woody, M.D.

University of Pennsylvania

More Information

No publications provided by National Institute on Drug Abuse (NIDA)

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

Schackman BR, Leff JA, Polsky D, Moore BA, Fiellin DA. Cost-effectiveness of long-term outpatient buprenorphine-naloxone treatment for opioid dependence in primary care. J Gen Intern Med. 2012 Jun;27(6):669-76. Epub 2012 Jan 4.

Subramaniam GA, Warden D, Minhajuddin A, Fishman MJ, Stitzer ML, Adinoff B, Trivedi M, Weiss R, Potter J, Poole SA, Woody GE. Predictors of abstinence: National Institute of Drug Abuse multisite buprenorphine/naloxone treatment trial in opioid-dependent youth. J Am Acad Child Adolesc Psychiatry. 2011 Nov;50(11):1120-8.

Polsky D, Glick HA, Yang J, Subramaniam GA, Poole SA, Woody GE. Cost-effectiveness of extended buprenorphine-naloxone treatment for opioid-dependent youth: data from a randomized trial. Addiction. 2010 Sep;105(9):1616-24. Epub 2010 Jul 12.

Meade CS, Weiss RD, Fitzmaurice GM, Poole SA, Subramaniam GA, Patkar AA, Connery HS, Woody GE. HIV risk behavior in treatment-seeking opioid-dependent youth: results from a NIDA clinical trials network multisite study. J Acquir Immune Defic Syndr. 2010 Sep 1;55(1):65-72.

Chakrabarti A, Woody GE, Griffin ML, Subramaniam G, Weiss RD. Predictors of buprenorphine-naloxone dosing in a 12-week treatment trial for opioid-dependent youth: Secondary analyses from a NIDA Clinical Trials Network study. Drug Alcohol Depend. 2010 Mar 1;107(2-3):253-6. Epub 2009 Nov 30.

Woody GE, Poole SA, Subramaniam G, Dugosh K, Bogenschutz M, Abbott P, Patkar A, Publicker M, McCain K, Potter JS, Forman R, Vetter V, McNicholas L, Blaine J, Lynch KG, Fudala P. Extended vs short-term buprenorphine-naloxone for treatment of opioid-addicted youth: a randomized trial. JAMA. 2008 Nov 5;300(17):2003-11.

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
Substance-Related Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Naloxone
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on May 23, 2013