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

January 13, 2017 updated by: National Institute on Drug Abuse (NIDA)

HCV Treatment of IDUs After Buprenorphine Stabilization

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94612
        • O.A.S.I.S.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pegInterferon
Open label, observational trial to determine the safety of HCV treatment in active IDUs stabilized on buprenorphine/naloxone
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety assessments

Secondary Outcome Measures

Outcome Measure
Compliance
Effectiveness of medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Collaborators

Organization to Achieve Solutions in Substance Abuse (OASIS)

Investigators

  • Principal Investigator: Diana L Sylvestre, M.D., Organization to Achieve Solutions in Substance Abuse (OASIS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

March 1, 2004

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

November 3, 2005

First Submitted That Met QC Criteria

November 3, 2005

First Posted (Estimate)

November 7, 2005

Study Record Updates

Last Update Posted (Estimate)

January 16, 2017

Last Update Submitted That Met QC Criteria

January 13, 2017

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-15629-1
  • R01-15629-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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