Evaluation of Neurocognitive Performance, Quality of Life, and Emotional State in Drug Substituted Patients (Methadone, Buprenorphine, Suboxone) Under Hepatitis C Therapy (Peginterferon Alfa and Ribavirin)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Time course of neurocognitive performance (as assessed by the TAP - Test Battery for Attentional Performance)
研究概览
简要总结
Prospective, longitudinal multi-center study performed in 15 participating substitution centers in Germany.
Aims:
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Primary objective: To compare the impact of the different substitution drugs (methadone, buprenorphine, and suboxone) on the neurocognitive, emotional, and quality-of-life-related tolerability in opioid dependent patients under HCV treatment.
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Secondary objective: To investigate if IFN therapy impairs efficacy (with respect to e.g. retention rates, concomitant drug use and in particular neurocognitive function) and tolerability of agonist maintenance treatment with methadone, buprenorphine, or suboxone
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Opioid-dependent patients on current stable agonist maintenance therapy (for at least 6 months prior to study enrolment) with methadone, buprenorphine, or suboxone.
- •Patients need to be infected with chronic hepatitis C and must have indication for therapy with peginterferon alfa and ribavirin.
- •Patients with informed written consent with respect to a follow-up of psychiatric side effects and in particular neurocognitive performance.
- •Patients with baseline monitoring of emotional state and neurocognitive performance.
排除标准
- •According to SPC
- •According to legal requirements reg. drug substitution therapy (BTMVV)
- •Insufficient knowledge of the German language or cognitive impairment (due to the indispensable application of questionnaires and the TAP, Test Battery of Attentional Performance).
- •Age under 18 years or over 65 years
- •coinfections such as hepatitis B virus or human immunodeficiency virus
结局指标
主要结局
Time course of neurocognitive performance (as assessed by the TAP - Test Battery for Attentional Performance)
时间窗: Repeated measures design with the following evaluation timepoints: baseline, twice to four times during antiviral treatment, twice after antiviral treatment
次要结局
未报告次要终点