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

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ClinicalTrials.gov Identifier: NCT00249574
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : January 16, 2017
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
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.  

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HCV Treatment of IDUs After Buprenorphine Stabilization
Study Start Date : June 2003
Primary Completion Date : March 2004
Study Completion Date : June 2006


Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Safety assessments

Secondary Outcome Measures :
  1. Effectiveness of medication
  2. Compliance

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: December 2008

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
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Heroin
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists