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

This study has been completed.

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) University of Pennsylvania
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00078130

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 III

MedlinePlus related topics: Rehabilitation

Drug Information available for: Naloxone Naloxone hydrochloride Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

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

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

National Institute on Drug Abuse (NIDA)

University of Pennsylvania

Investigators

Principal Investigator:

George Woody, M.D.

University of Pennsylvania

More Information

Publications indexed to this study:

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.

Study ID Numbers:	NIDA-CTN-0010-1
Study First Received:	February 19, 2004
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00078130
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Buprenorphine
Mental Disorders
Substance-Related Disorders

Disorders of Environmental Origin
Opioid-Related Disorders
Naloxone

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009