Pharmacokinetic Population Modeling of Methadone in Patients Managed for Opioid Opioid Addiction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Peak concentration (Cmax)
研究概览
简要总结
The management of patients with opioid addiction is a challenge insofar as many distractors or variability factors can interfere with the control of the addiction, whether they are psychological, psychiatric, environmental, pharmacokinetic or pharmacodynamic. Understanding this variability is potentially to be able to adjust a priori a dosage and to identify the factors of clinical response. Few population pharmacokinetic models exist for methadone and they generally concern the management of pain in palliative care patients or the management of opioid withdrawal syndrome in neonates. The hypothesis is therefore that the creation of such a model would make it possible to reduce patients' withdrawal periods, to set a target for plasma concentrations with a view to reducing dosages, and to empower the patient in his choice to monitor blood concentrations facilitated by a minimally invasive sampling device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major patients on methadone on the same dosage for at least 7 days.
- •Hospitalization for withdrawal in the addictology department of La Colombière or consultation within the unit for the treatment of drug addiction and dependence (Addictology Department).
- •24 hours monitoring is possible and accepted
排除标准
- •Patients that cannot be sampled because of weakened veins
- •Unable to received information about the study
- •Exclusion period determined by previous study
- •Adult protected by law or patient under guardianship
- •Not affiliated to french social security system
- •Not able to give written inform consent
- •Pregnant or breastfeeding woman
- •Underaged patients (under 18 years old)
- •Patient under court protection
研究组 & 干预措施
Therapeutic drug monitoring of methadone
6 samplings per subject: 3 venipunctures and 3 microsamplings
干预措施: Blood sampling (Biological)
结局指标
主要结局
Peak concentration (Cmax)
时间窗: 18 months
To evaluate and estimate methadone/EDDP (metabolite) Cmax for patients treated for opioid addiction.
次要结局
- C12h-24h concentration(18 months)
- Residual concentration (C0)(18 months)