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| Tracking Information | |||||
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| First Received Date ICMJE | February 19, 2004 | ||||
| Last Updated Date | July 28, 2008 | ||||
| Start Date ICMJE | July 2003 | ||||
| Primary Completion Date | January 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Opiate abstinence | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00078130 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Buprenorphine/Naloxone - Facilitated Rehabilitation for Opioid Dependent Adolescents - 1 | ||||
| Official Title ICMJE | Bup/Nx - Facilitated Rehab for Opioid Dependent Adolescents | ||||
| 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. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Opioid-Related Disorders | ||||
| Intervention ICMJE | Drug: Buprenorphine/naloxone | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 223 | ||||
| Completion Date | January 2006 | ||||
| Primary Completion Date | January 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Male and non-pregnant female subjects seeking outpatient treatment for opioid dependence with physiological features without serious medical or psychiatric disorders. |
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| Gender | Both | ||||
| Ages | 14 Years to 21 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00078130 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | NIDA-CTN-0010-1 | ||||
| Study Sponsor ICMJE | National Institute on Drug Abuse (NIDA) | ||||
| Collaborators ICMJE | University of Pennsylvania | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute on Drug Abuse (NIDA) | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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