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

NCT ID: NCT00249574

Last Updated: 2017-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2006-06-30

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.

Conditions

Hepatitis C; Heroin Dependence

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pegInterferon

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

Group Type: EXPERIMENTAL

Buprenorphine/naloxone

Intervention Type: DRUG

Human subjects HIV, HCV

pegInterferon

Intervention Type: DRUG

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.

Interventions

Buprenorphine/naloxone

Human subjects HIV, HCV

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organization to Achieve Solutions in Substance Abuse (OASIS)

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Responsible Party

O.A.S.I.S

Principal Investigators

Diana L Sylvestre, M.D.

Role: PRINCIPAL_INVESTIGATOR

Organization to Achieve Solutions in Substance Abuse (OASIS)

Locations

O.A.S.I.S.

Oakland, California, United States

Countries

United States

Other Identifiers

R01-15629-1

Identifier Type: -

Identifier Source: secondary_id

NIDA-15629-1

Identifier Type: -

Identifier Source: org_study_id