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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Active, not recruiting
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: NA
Last verified: October 2005
History: No changes posted
  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

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: 0
Study Start Date: June 2003
Estimated Study Completion Date: July 2005
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
Genders Eligible for Study:   Both
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
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

No publications provided

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: November 3, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hepatitis
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
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on August 20, 2014