Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015028
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2001-04-18
Brief Title:
BuprenorphineNaloxone for Opiate-Dependence Treatment - 1
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
CS1008A EfficacySafety Trial of BuprenorphineNaloxone
Status:
COMPLETED
Status Verified Date:
1996-11
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 determine the efficacy and safety of a buprenorphinenaloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment The developmental objective for this combination product is an expansion of therapeutic options for the treatment of opiate dependence
Detailed Description:
This multicenter pivotal clinical trial was comprised of two phases The first phase which was four weeks in length was double-blind placebo controlled and was primarily used to evaluate the efficacy of buprenorphinenaloxone The second phase lasting 48 weeks was primarily conducted to determine the safety of buprenorphinenaloxone
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 |
|---|---|---|---|
| Y01-5-0012-1 | None | None | None |