Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000327
Status:
WITHDRAWN
Last Update Posted:
2017-05-04
First Post:
1999-09-20
Brief Title:
BuprenorphineNaloxone Treatment for Opioid Dependence-Experiment I2 - 2
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
BuprenorphineNaloxone Treatment for Opioid Dependence-Experiment I2
Status:
WITHDRAWN
Status Verified Date:
2017-05
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 compare the clinical efficacy of daily vs 3-day MWF buprenorphinenaloxone combination tablet administration and determine whether outcomes are improved when using a 3-day schedule in which all doses are ingested at the clinic vs one in which take-home doses are given on intervening days
Detailed Description:
MonWedFri dosing with the 8 mg buprenorphinenaloxone tablet is as safe and effective as daily dosing and is preferred by patients to daily dosing Multiple doses of the combination tablet eg 16mg 24mg are well tolerated by patients A 3 day schedule with take-outs is as effective as a 3-day schedule in which all medication is ingested at the clinic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01-11160-2 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01DA011160 |
| R01DA011160 | NIH | None | None |