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

Sponsor

National Institute on Drug Abuse (NIDA) (NIH)

Overall Status

Completed

CT.gov ID

NCT00249574

Collaborator

Organization to Achieve Solutions in Substance Abuse (OASIS) (Other)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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	Phase
Hepatitis C Heroin Dependence	Drug: Buprenorphine/naloxone Drug: pegInterferon	N/A

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

Anticipated 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 :

Jun 1, 2003

Actual Primary Completion Date :

Mar 1, 2004

Actual Study Completion Date :

Jun 1, 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.

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

Safety assessments []

Secondary Outcome Measures

Effectiveness of medication []
Compliance []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00249574

Other Study ID Numbers:

NIDA-15629-1
R01-15629-1

First Posted:

Nov 7, 2005

Last Update Posted:

Jan 16, 2017

Last Verified:

Dec 1, 2008

Keywords provided by , ,

heroin addiction

Additional relevant MeSH terms:

Buprenorphine, Naloxone Drug Combination

Naloxone

Study Results

No Results Posted as of Jan 16, 2017