Trial | NCT00249574  Report issue

Title

Bridging Active Heroin Users to Hepatitis C Treatment Using Buprenorphine - 1
HCV Treatment of IDUs After Buprenorphine Stabilization

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    10
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.
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 buprenorphine/naloxone 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 Started
Jun 30
2003
Primary Completion
Mar 31
2004
Study Completion
Jun 30
2006
Last Update
Jan 16
2017
Estimate

Drug Buprenorphine/naloxone

Human subjects HIV, HCV

Drug pegInterferon

intervention drug 1. buprenorphine/naloxone. street-recruited heroin users induced on bup/naloxone for period of 3-6 months, after which the second intervention is offered. intervention drug 2: pegInterferon/ribavirin. subjects interested in initiation treatment for HCV are offered pegInterferon, 180ug SQ/wk and ribavirin, 800-1200 mg daily for the standard duration of HCV treatment as dictated by genotype.

pegInterferon Experimental

Open label, observational trial to determine the safety of HCV treatment in active IDUs stabilized on buprenorphine/naloxone

Criteria 

Inclusion Criteria:

Active heroin or other illicit opioid use
Active hepatitis C
No medical or psychiatric contraindications
Able to sign informed consent

Exclusion Criteria:

No opiate dependence
Age <18
Unable or uninterested in attending weekly group sessions
No Results Posted