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Completed

NCT Number: NCT00249574

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

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Heroin Dependence Infections Liver Diseases Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders RNA Virus Infections Substance-Related Disorders Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

O.A.S.I.S.

Oakland, California, 94612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

buprenorphine/naloxone

Drug

Human subjects HIV, HCV

Peginterferon

Drug

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

  1. Safety assessments

Secondary outcomes

  1. Effectiveness of medication

  2. Compliance

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Collaborators

  • Organization to Achieve Solutions in Substance Abuse (OASIS)

Registry information

Official study title

HCV Treatment of IDUs After Buprenorphine Stabilization

Important dates

Study start
2003
Primary completion
2004
Study completion
2006
First posted
Nov 7, 2005
Registry last updated
Jan 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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