Bridging Active Heroin Users to Hepatitis C Treatment Using Buprenorphine - 1
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention |
|---|---|
|
Hepatitis C Heroin Dependence |
Drug: Buprenorphine/naloxone |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | HCV Treatment of IDUs After Buprenorphine Stabilization |
- Safety assessments
- Effectiveness of medication
- Compliance
| Estimated Enrollment: | 0 |
| Study Start Date: | June 2003 |
| Estimated Study Completion Date: | July 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| United States, California | |
| O.A.S.I.S. | |
| Oakland, California, United States, 94612 | |
| Principal Investigator: | Diana L Sylvestre, M.D. | Organization to Achieve Solutions in Substance Abuse (OASIS) |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00249574 History of Changes |
| Other Study ID Numbers: | NIDA-15629-1, R01-15629-1 |
| Study First Received: | November 3, 2005 |
| Last Updated: | November 3, 2005 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Heroin Dependence Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Opioid-Related Disorders Substance-Related Disorders |
Mental Disorders Buprenorphine Naloxone Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics |
ClinicalTrials.gov processed this record on May 23, 2013