Substance-Related Disorders Clinical Trial
Official title:
PK 0396 - Buprenorphine Dose Escalation Trial
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.
;
Primary Purpose: Treatment
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