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| Tracking Information | |||||
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| First Received Date ICMJE | September 20, 1999 | ||||
| Last Updated Date | November 3, 2005 | ||||
| Start Date ICMJE | June 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 NCT00000327 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2 | ||||
| Official Title ICMJE | Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) | ||||
| Brief Summary | The purpose of this study is to compare the clinical efficacy of daily vs. 3-day (MWF) buprenorphine/naloxone combination tablet administration and determine whether outcomes are improved when using a 3-day schedule in which all doses are ingested at the clinic vs. one in which take-home doses are given on intervening days. |
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| Detailed Description | Mon/Wed/Fri dosing with the 8 mg buprenorphine/naloxone tablet is as safe and effective as daily dosing and is preferred by patients to daily dosing. Multiple doses of the combination tabelt (e.g. 16mg, 24mg) are well tolerated by patients. A 3 day schedule with take-outs is as effective as a 3-day schedule in which all medication is ingested at the clinic |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Double-Blind, Crossover Assignment | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Heroin Dependence | ||||
| 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: Individual must be currently dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency. Exclusion Criteria: Individuals with evidence of an active DSM-IV Axis I psychiatric disorder (e.g., psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation. |
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| Gender | Both | ||||
| Ages | 18 Years to 62 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 | NCT00000327 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | NIDA-11160-2, R01-11160-2 | ||||
| Study Sponsor ICMJE | National Institute on Drug Abuse (NIDA) | ||||
| Collaborators ICMJE | University of Colorado at Denver and Health Sciences Center | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute on Drug Abuse (NIDA) | ||||
| Verification Date | November 1997 | ||||
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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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