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临床试验/NCT00249574
NCT00249574已完成不适用

HCV Treatment of IDUs After Buprenorphine Stabilization

National Institute on Drug Abuse (NIDA)1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2003年6月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Experimental

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

研究者

申办方类型
Nih

研究点 (1)

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