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

Hepatitis C Clinical Trial

Official title:

HCV Treatment of IDUs After Buprenorphine Stabilization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00249574
• Other study ID #: NIDA-15629-1
• Secondary ID: R01-15629-1
• Status: Completed
• Phase: N/A
• First received: November 3, 2005
• Last updated: January 13, 2017
• Start date: June 2003
• Est. completion date: June 2006

Study information

• Verified date: December 2008
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2006
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Heroin Dependence

Intervention

Drug:
• Buprenorphine/naloxone
Human subjects HIV, HCV
• 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.

Locations

Country	Name	City	State
United States	O.A.S.I.S.	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	Organization to Achieve Solutions in Substance Abuse (OASIS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessments
Secondary	Effectiveness of medication
Secondary	Compliance