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

Not Applicable

Completed

• Conditions: Heroin Dependence; Hepatitis C
• Interventions: Drug: Buprenorphine/naloxone; Drug: pegInterferon

• Registration Number: NCT00249574
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

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 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 Timeline

• Study Start: 2003-06
• Primary Completion: 2004-03
• Study First Submitted: 2005-11-03
• Study First Submitted QC: 2005-11-03
• Study First Posted: 2005-11-07
• Study Completion: 2006-06
• Status Verified: 2008-12
• Last Update Submitted: 2017-01-13
• Last Update Posted: 2017-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Safety assessments

Secondary Outcome Measures

Name	Time	Method
Compliance
Effectiveness of medication

Trial Locations

Locations (1)

O.A.S.I.S.; 🇺🇸 Oakland, California, United States