Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00316277
Status:
COMPLETED
Last Update Posted:
2013-02-06
First Post:
2006-04-18
Brief Title:
Prescription Opioid Addiction Treatment Study POATS
Sponsor:
Mclean Hospital
Organization:
Mclean Hospital
Study Overview
Official Title:
A Two-Phase Randomized Controlled Clinical Trial of BuprenorphineNaloxone Treatment Plus Standard Medical Management or Enhanced Medical Management for Opioid Analgesic Dependence
Status:
COMPLETED
Status Verified Date:
2013-02
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 whether treatment outcome for subjects dependent on prescription opioid analgesics can be improved by adding individual drug counseling to the prescription of buprenorphinenaloxone with standard medical management This will be examined during a an initial four-week treatment with taper b a 12-week stabilization treatment for those who do not respond successfully to the initial treatment and c a long-term follow-up assessment at 15 years 25 years and 35 years after treatment
Detailed Description:
This is a randomized 2-phase open-label multi-center study conducted in outpatient treatment settings The main objective of this study is to identify an effective sublingual buprenorphinenaloxone treatment regimen for subjects dependent on prescription opioids Phase 1 of this study will assess the prevailing one-month detoxification practice This phase will assess the benefits of individual drug counseling in a short-term treatment paradigm The second phase of this study will assess the benefit of individual drug counseling in a longer-term treatment paradigm for participants who did not respond successfully to the short-term buprenorphinenaloxone treatment There is also a long-term follow-up assessment to determine outcomes at 15 years 25 years and 35 years after treatment
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