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| Tracking Information | |||||
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| First Received Date ICMJE | April 18, 2001 | ||||
| Last Updated Date | August 26, 2008 | ||||
| Start Date ICMJE | November 1997 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00015340 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Buprenorphine/Naloxone in the Treatment of Heroin Dependence - 14 | ||||
| Official Title ICMJE | Buprenorphine/Nx Treatment of Heroin Dependence-A Compassionate Use Study | ||||
| Brief Summary | The purpose of this study is the safety and efficacy of Burprenorphine/Naloxone in the treatment of opioid dependence. A compassionate use study. |
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| Detailed Description | The objective of this study is to provide follow-up compassionate use treatment and evaluate long term safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment for subjects who have completed CS 1008 A and B. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Buprenorphine/naloxone | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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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 | 0 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: completions of CS 1008 A/B Exclusion Criteria: Significant medical or psychiatric illness. Non-compliance with study procedures in CS 1008 A/B |
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| Gender | Both | ||||
| Ages | 18 Years to 59 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 | NCT00015340 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | NIDA-5-0013-14, Y01-5-0013-14 | ||||
| Study Sponsor ICMJE | National Institute on Drug Abuse (NIDA) | ||||
| Collaborators ICMJE | New York MDRU | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute on Drug Abuse (NIDA) | ||||
| Verification Date | August 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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