Hepatitis C, Heroin Dependence
Conditions
Keywords
heroin addiction
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.
Interventions
DRUGBuprenorphine/naloxone
Human subjects HIV, HCV
DRUGpegInterferon
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.
Sponsors
Organization to Achieve Solutions in Substance Abuse (OASIS)
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessments | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness of medication | — |
| Compliance | — |
Countries
United States
Outcome results
None listed