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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00249574
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : January 16, 2017
Organization to Achieve Solutions in Substance Abuse (OASIS)
Information provided by:
National Institute on Drug Abuse (NIDA)

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 Phase
Hepatitis C Heroin Dependence Drug: Buprenorphine/naloxone Drug: pegInterferon Not Applicable

Expanded Access : 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.

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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
Actual Primary Completion Date : March 2004
Actual Study Completion Date : June 2006

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.

Primary Outcome Measures :
  1. Safety assessments

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00249574

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United States, California
Oakland, California, United States, 94612
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Organization to Achieve Solutions in Substance Abuse (OASIS)
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Principal Investigator: Diana L Sylvestre, M.D. Organization to Achieve Solutions in Substance Abuse (OASIS)
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Responsible Party: Diana Sylvestre, O.A.S.I.S Identifier: NCT00249574    
Other Study ID Numbers: NIDA-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:
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Hepatitis A
Hepatitis C
Heroin Dependence
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine, Naloxone Drug Combination
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists