Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015041
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2001-04-18
Brief Title:
Buprenorphine Dose Escalation Trial for Treatment of Non-Dependent Opiate Users - 2
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
PK 0396 - Buprenorphine Dose Escalation Trial
Status:
COMPLETED
Status Verified Date:
1998-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Y01-5-0012-2 | None | None | None |