Primary Outcome Measures:
- PK parameters of buprenorphine
- Intoxication and withdrawal
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.