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

This study has been completed.
Sponsor:
Collaborator:
Organization to Achieve Solutions in Substance Abuse (OASIS)
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00249574
First received: November 3, 2005
Last updated: January 12, 2017
Last verified: December 2008
  Purpose
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.

Condition Intervention
Hepatitis C
Heroin Dependence
Drug: Buprenorphine/naloxone
Drug: pegInterferon

National Institute on Drug Abuse (NIDA) has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HCV Treatment of IDUs After Buprenorphine Stabilization

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Safety assessments

Secondary Outcome Measures:
  • Effectiveness of medication
  • Compliance

Estimated Enrollment: 10
Study Start Date: June 2003
Study Completion Date: June 2006
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249574

Locations
United States, California
O.A.S.I.S.
Oakland, California, United States, 94612
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Organization to Achieve Solutions in Substance Abuse (OASIS)
Investigators
Principal Investigator: Diana L Sylvestre, M.D. Organization to Achieve Solutions in Substance Abuse (OASIS)
  More Information

Responsible Party: Diana Sylvestre, O.A.S.I.S
ClinicalTrials.gov Identifier: NCT00249574     History of Changes
Other Study ID Numbers: NIDA-15629-1  R01-15629-1 
Study First Received: November 3, 2005
Last Updated: January 12, 2017
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):
heroin addiction

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Heroin Dependence
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naloxone
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Heroin
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics

ClinicalTrials.gov processed this record on January 14, 2017