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.
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: 1. two 2-mg buprenorphine sublingual tablets, 2. one 8-mg buprenorphine sublingual tablet, 3. two 8-mg buprenorphine sublingual tablets; and 4. three 8-mg buprenorphine sublingual tablets. 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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Cincinnati MDRU
Cincinnati, Ohio, United States
PK parameters of buprenorphine
Intoxication and withdrawal
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