Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-25 @ 5:05 PM
Study NCT ID:
NCT01262261
Status:
COMPLETED
Last Update Posted:
2018-12-31
First Post:
2010-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Re-Treatment Study of Probuphine in Opioid Addiction
Sponsor:
Titan Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase 3, Six-Month, Open-Label, Re-Treatment Study of Probuphine in Opioid Addiction
Status:
COMPLETED
Status Verified Date:
2017-06
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:
Probuphine (buprenorphine implant) is an investigational implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This is a 6-month, open-label, re-treatment study that will confirm the safety and efficacy of Probuphine in patients who have previously completed the 6-month PRO-806 study with either Probuphine, placebo or sublingual buprenorphine.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: