NCT00015041

Buprenorphine Dose Escalation Trial for Treatment of Non-Dependent Opiate Users - 2

PK 0396 - Buprenorphine Dose Escalation Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (planned)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Opioid-Related Disorders
• Substance-Related Disorders

Interventions

Type	Name	Description
DRUG	Buprenorphine

Timeline

• Start date: 1996-11-01
• Primary completion: 1998-06-01
• Completion: 1998-07-01
• First posted: 2001-04-18
• Last updated: 2017-01-12

Locations

1 site across 1 country: United States