Overview

This trial is active, not recruiting.

Conditions hepatitis c, heroin dependence
Treatment buprenorphine/naloxone
Sponsor National Institute on Drug Abuse (NIDA)
Collaborator Organization to Achieve Solutions in Substance Abuse (OASIS)
Start date June 2003
End date July 2005
Trial size 0 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

Primary Outcomes

Measure
Safety assessments
time frame:

Secondary Outcomes

Measure
Effectiveness of medication
time frame:
Compliance
time frame:

Eligibility Criteria

Male or female 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 November 2005.
Information provided to ClinicalTrials.gov by National Institute on Drug Abuse (NIDA).