Back to resultsBuprenorphine/Naloxone - Facilitated Rehabilitation for Opioid Dependent Adolescents - 1
Primary Purpose
Opioid-Related Disorders
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine/naloxone
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Related Disorders focused on measuring opioid dependence, behavioral intervention
Eligibility Criteria
Male and non-pregnant female subjects seeking outpatient treatment for opioid dependence with physiological features without serious medical or psychiatric disorders.
Sites / Locations
- Mercy Hospital
- Mountain Manor
- ASAP
- Duke Addictions Program
Outcomes
Primary Outcome Measures
Opiate abstinence
Secondary Outcome Measures
Full Information
NCT ID
NCT00078130
First Posted
February 19, 2004
Last Updated
January 11, 2017
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT00078130
Brief Title
Buprenorphine/Naloxone - Facilitated Rehabilitation for Opioid Dependent Adolescents - 1
Official Title
Bup/Nx - Facilitated Rehab for Opioid Dependent Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders
Keywords
opioid dependence, behavioral intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
223 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Buprenorphine/naloxone
Primary Outcome Measure Information:
Title
Opiate abstinence
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Male and non-pregnant female subjects seeking outpatient treatment for opioid dependence with physiological features without serious medical or psychiatric disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Woody, M.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Hospital
City
Portland
State/Province
Maine
ZIP/Postal Code
04092
Country
United States
Facility Name
Mountain Manor
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
ASAP
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Duke Addictions Program
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
36063082
Citation
Nielsen S, Tse WC, Larance B. Opioid agonist treatment for people who are dependent on pharmaceutical opioids. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD011117. doi: 10.1002/14651858.CD011117.pub3.
Results Reference
derived
PubMed Identifier
22215271
Citation
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. doi: 10.1007/s11606-011-1962-8. Epub 2012 Jan 4.
Results Reference
derived
PubMed Identifier
22024000
Citation
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. doi: 10.1016/j.jaac.2011.07.010.
Results Reference
derived
PubMed Identifier
20626379
Citation
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. doi: 10.1111/j.1360-0443.2010.03001.x. Epub 2010 Jul 12.
Results Reference
derived
PubMed Identifier
20393347
Citation
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;55(1):65-72. doi: 10.1097/QAI.0b013e3181d916db.
Results Reference
derived
PubMed Identifier
19948382
Citation
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. doi: 10.1016/j.drugalcdep.2009.10.014. Epub 2009 Nov 30.
Results Reference
derived
PubMed Identifier
18984887
Citation
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. doi: 10.1001/jama.2008.574. Erratum In: JAMA. 2009 Feb 25;301(8):830. JAMA. 2013 Apr 10;309(14):1461.
Results Reference
derived
Learn more about this trial
Buprenorphine/Naloxone - Facilitated Rehabilitation for Opioid Dependent Adolescents - 1
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