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

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ClinicalTrials.gov Identifier: NCT00078130
Recruitment Status : Completed
First Posted : February 20, 2004
Last Update Posted : January 12, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
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 or disease Intervention/treatment Phase
Opioid-Related Disorders Drug: Buprenorphine/naloxone Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 223 participants
Primary Purpose: Treatment
Official Title: Bup/Nx - Facilitated Rehab for Opioid Dependent Adolescents
Study Start Date : July 2003
Primary Completion Date : January 2006
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Opiate abstinence


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 20, 2004    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: October 2016

Keywords provided by National Institute on Drug Abuse (NIDA):
opioid dependence
behavioral intervention

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