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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) Cincinnati MDRU |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00015041 |
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.
Condition | Intervention | Phase |
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Opioid-Related Disorders Substance-Related Disorders |
Drug: Buprenorphine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Dose Comparison |
Official Title: | PK 0396 - Buprenorphine Dose Escalation Trial |
Estimated Enrollment: | 0 |
Study Start Date: | November 1996 |
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.
Ages Eligible for Study: | 21 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | NIDA-5-0012-2, Y01-5-0012-2 |
Study First Received: | April 18, 2001 |
Last Updated: | November 3, 2005 |
ClinicalTrials.gov Identifier: | NCT00015041 |
Health Authority: | United States: Federal Government |
Buprenorphine Mental Disorders Substance-Related Disorders Disorders of Environmental Origin Opioid-Related Disorders |
Disease Physiological Effects of Drugs Narcotic Antagonists Central Nervous System Depressants Narcotics Pharmacologic Actions Pathologic Processes |
Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |