Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249574
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2005-11-03
Brief Title:
Bridging Active Heroin Users to Hepatitis C Treatment Using Buprenorphine - 1
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
HCV Treatment of IDUs After Buprenorphine Stabilization
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see whether street-recruited heroin users can be successfully treated for hepatitis C after stabilizing them on buprenorphine
Detailed Description:
This is a prospective pilot safety study based on the hypothesis that active street-recruited heroin users can be successfully treated for hepatitis C after stabilization on buprenorphine Eligible subjects will be actively using heroin and have hepatitis C viremia screening will occur at street-based sites like syringe exchange programs Those who are eligible will sign informed consent and then be asked to attend 3 weekly educational sessions about hepatitis C and addiction as well as undergo an intake interview After this subjects will be inducted onto buprenorphinenaloxone combination therapy Suboxone and receive this medication for 12-24 weeks Once reaching the 12-24 week study time point subjects will have the option of a 12-week Suboxone taper or instead of undergoing 6-12 months of hepatitis C treatment with pegylated interferon and ribavirin while being maintained on Suboxone Once completing hepatitis C treatment subjects will undergo a 24-week Suboxone taper or be transitioned to outpatient Suboxone therapy by a medical provider
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 |
|---|---|---|---|
| R01-15629-1 | None | None | None |