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

Primary Purpose

Hepatitis C, Heroin Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine/naloxone
pegInterferon
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring heroin addiction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • O.A.S.I.S.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pegInterferon

Arm Description

Open label, observational trial to determine the safety of HCV treatment in active IDUs stabilized on buprenorphine/naloxone

Outcomes

Primary Outcome Measures

Safety assessments

Secondary Outcome Measures

Effectiveness of medication
Compliance

Full Information

First Posted
November 3, 2005
Last Updated
January 13, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Organization to Achieve Solutions in Substance Abuse (OASIS)
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1. Study Identification

Unique Protocol Identification Number
NCT00249574
Brief Title
Bridging Active Heroin Users to Hepatitis C Treatment Using Buprenorphine - 1
Official Title
HCV Treatment of IDUs After Buprenorphine Stabilization
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Organization to Achieve Solutions in Substance Abuse (OASIS)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Heroin Dependence
Keywords
heroin addiction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pegInterferon
Arm Type
Experimental
Arm Description
Open label, observational trial to determine the safety of HCV treatment in active IDUs stabilized on buprenorphine/naloxone
Intervention Type
Drug
Intervention Name(s)
Buprenorphine/naloxone
Intervention Description
Human subjects HIV, HCV
Intervention Type
Drug
Intervention Name(s)
pegInterferon
Intervention Description
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 Measure Information:
Title
Safety assessments
Secondary Outcome Measure Information:
Title
Effectiveness of medication
Title
Compliance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana L Sylvestre, M.D.
Organizational Affiliation
Organization to Achieve Solutions in Substance Abuse (OASIS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
O.A.S.I.S.
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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