Factors Associated With the Variance of Oral Methadone Dosage at Steady State of Maintenance Treatment: Description of Bio-markers of Phenotype and Genotype.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Functional activity CYP3A4
研究概览
简要总结
The purpose of this study is to describe clinical, pharmacokinetic and genetic factors associated with the variance of oral methadone dosage for patients at the steady state of heroin dependence maintenance treatment. The hypothesis is that the investigators can predict 70% of the variance with few factors, including CYP 3A4 function measured with oral midazolam challenge.
详细描述
Patients at the steady state of methadone maintenance treatment may receive oral dosage ranging from 5 to 130 mg per day in our clinical practice. This study is aimed at providing a comprehensive cross-sectional description of factors involved in this variance:
- comorbidity with addictive and psychiatric disorders
- severity of pre-existing heroin dependence
- function of CYP 3A4 enzyme assessed with oral midazolam challenge
- genetic polymorphisms of enzymes implicated in methadone pharmacokinetic and pharmacodynamic (CYPs, MDR1, OPRM1, COMT)
The expected result is a predictive equation of oral methadone dosage at steady state.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •heroin dependence
- •under maintenance treatment with methadone
- •at steady state: stable oral methadone dosage since 3 months at least
排除标准
- •current heroin dependence or abuse
- •current cocaine and/or alcohol and/or sedatives dependence
- •pregnancy
结局指标
主要结局
Functional activity CYP3A4
时间窗: Day15
Functional activity CYP3A4 as measured by the ratio of metabolite / parent drug provided by the functional test the oral midazolam.
次要结局
未报告次要终点