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Tracking Information | |||||
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First Received Date † | April 18, 2001 | ||||
Last Updated Date | November 3, 2005 | ||||
Start Date † | November 1996 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00015041 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Buprenorphine Dose Escalation Trial for Treatment of Non-Dependent Opiate Users - 2 | ||||
Official Title † | PK 0396 - Buprenorphine Dose Escalation Trial | ||||
Brief Summary | The purpose of this study is to evaluate the effect, pharmacokinetics and dose proportionality of buprenorphine when administered to non-dependent opiate users. 1) To evaluate whether plasma concentrations of buprenorphine increase proportionally to buprenorphine dose. 2) To evaluate the dose-response of subjective and physiological effects of buprenorphine; and 3) To determine the safety of buprenorphine. |
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Detailed Description | This will be an open-label, single dose-escalation trial. A total of 24 opiate experienced, but not dependent subjects will receive four ascending doses of buprenorphine, 4, 8, 16, and 24 mg, respectively, with an at least a 14 day washout interval between treatments. The four treatments are sublingual administration of:
The dose proportionality in plasma profiles of buprenorphine and dose response of the buprenorphine sublingual tablets are evaluated at buprenorphine dose range of 4 to 24 mg. |
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Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Dose Comparison | ||||
Condition † |
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Intervention † | Drug: Buprenorphine | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* 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 † | Completed | ||||
Enrollment † | 0 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 21 Years to 45 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00015041 | ||||
Responsible Party | |||||
Secondary IDs †† | Y01-5-0012-2 | ||||
Study Sponsor † | National Institute on Drug Abuse (NIDA) | ||||
Collaborators †† | Cincinnati MDRU | ||||
Investigators † |
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Information Provided By | National Institute on Drug Abuse (NIDA) | ||||
Verification Date | July 1998 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |