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| ID | Type | Description | Link |
|---|---|---|---|
| R01-15629-1 |
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| Name | Class |
|---|---|
| Organization to Achieve Solutions in Substance Abuse (OASIS) | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pegInterferon | Experimental | Open label, observational trial to determine the safety of HCV treatment in active IDUs stabilized on buprenorphine/naloxone |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine/naloxone | Drug | Human subjects HIV, HCV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessments |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of medication | ||
| Compliance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana L Sylvestre, M.D. | Organization to Achieve Solutions in Substance Abuse (OASIS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| O.A.S.I.S. | Oakland | California | 94612 | United States |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D006556 | Heroin Dependence |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| pegInterferon |
| 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. |
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D009293 | Opioid-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D006571 |
| Heterocyclic Compounds |
| D009270 | Naloxone |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |