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

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

ChemIDplus related topics:

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

Study ID Numbers:	NIDA-CTN-0010-1
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 October 15, 2008