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

National Institutes of Health (NIH)

Status: Completed

Conditions: Heroin Dependence; Hepatitis C

Treatments: Drug: pegInterferon; Drug: Buprenorphine/naloxone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00249574

NIDA-15629-1

R01-15629-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

pegInterferon

Experimental group

Description:

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

Treatment:

Drug: Buprenorphine/naloxone

Drug: pegInterferon