Buprenorphine Dose Escalation Trial for Treatment of Non-Dependent Opiate Users - 2
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||PK 0396 - Buprenorphine Dose Escalation Trial|
- PK parameters of buprenorphine
- Intoxication and withdrawal
|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:
- two 2-mg buprenorphine sublingual tablets,
- one 8-mg buprenorphine sublingual tablet,
- two 8-mg buprenorphine sublingual tablets; and
- 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.
|United States, Ohio|
|Cincinnati, Ohio, United States, 45220|
|Principal Investigator:||Eugene Somoza, M.D., Ph.D.||Cincinnati MDRU|