NCT00249574

Bridging Active Heroin Users to Hepatitis C Treatment Using Buprenorphine - 1

HCV Treatment of IDUs After Buprenorphine Stabilization

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Hepatitis C
• Heroin Dependence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2003-06-01
• Primary completion: 2004-03-01
• Completion: 2006-06-01
• First posted: 2005-11-07
• Last updated: 2017-01-16

Locations

1 site across 1 country: United States