HCV Treatment of IDUs After Buprenorphine Stabilization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety assessments
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active heroin or other illicit opioid use
- •Active hepatitis C
- •No medical or psychiatric contraindications
- •Able to sign informed consent
排除标准
- •No opiate dependence
- •Unable or uninterested in attending weekly group sessions
研究组 & 干预措施
pegInterferon
Open label, observational trial to determine the safety of HCV treatment in active IDUs stabilized on buprenorphine/naloxone
干预措施: Buprenorphine/naloxone (Drug)
pegInterferon
Open label, observational trial to determine the safety of HCV treatment in active IDUs stabilized on buprenorphine/naloxone
干预措施: pegInterferon (Drug)
结局指标
主要结局
Safety assessments
次要结局
- Compliance
- Effectiveness of medication
