Overview

This trial has been completed.

Conditions hepatitis c, heroin dependence
Treatments buprenorphine/naloxone, peginterferon
Sponsor National Institute on Drug Abuse (NIDA)
Collaborator Organization to Achieve Solutions in Substance Abuse (OASIS)
Start date June 2003
End date March 2004
Trial size 10 participants
Trial identifier NCT00249574, NIDA-15629-1, R01-15629-1

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Open label, observational trial to determine the safety of HCV treatment in active IDUs stabilized on buprenorphine/naloxone
buprenorphine/naloxone
Human subjects HIV, HCV
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.

Primary Outcomes

Measure
Safety assessments
time frame:

Secondary Outcomes

Measure
Effectiveness of medication
time frame:
Compliance
time frame:

Eligibility Criteria

All participants from 18 years up to 80 years old.

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

Additional Information

Official title HCV Treatment of IDUs After Buprenorphine Stabilization
Principal investigator Diana L Sylvestre, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by National Institute on Drug Abuse (NIDA).