Methadone Monitoring for Insights Into Adverse Events
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Total Methadone Peak Plasma Concentration
研究概览
简要总结
Methadone has been an effective and inexpensive therapy in the management of chronic pain and opioid dependence. However it has been associated with sudden, unexpected deaths. Two mechanisms have been suggested, increased drug concentration in the blood, and a change in the heart rhythm. This study will look at blood samples for drug levels and genetic components and EKG's (a noninvasive test which reveals heart rhythm). There will be no intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •must be 18 years of age or older; eligible for methadone treatment as judged by Discovery House criteria
- •must sign informed consent for methadone treatment prior to being approached for this study
- •must sign a written informed consent for this study
- •is willing and has a means to return for all scheduled follow-up visits
排除标准
- •pregnancy, participation in any other clinical trial involving investigational or marketed products with 30 days prior to entry into this study; current use of an inducer/inhibitor of known enzymes involved with methadone metabolism
- •use of methadone in the 30 days prior to study enrollment; concomitant use of QT prolonging drugs
- •considered by the treatment physician to be ineligible for methadone treatment; hepatic function panel indicates chronic liver disease.
结局指标
主要结局
Total Methadone Peak Plasma Concentration
时间窗: Day 1, Day 7, Day 21
(S)- Methadone Peak Plasma Concentration
时间窗: Day 1, Day 7, Day 21
(R)-Methadone Peak Plasma Concentration
时间窗: Day 1, Day 7, Day 21
(R)-Methadone Trough Plasma Concentration
时间窗: Day 1, Day 7, Day 21
(S)-EDDP Peak Plasma Concentration
时间窗: Day 1, Day 7, Day 21
(R)-EDDP Peak Plasma Concentration
时间窗: Day 1, Day 7, Day 21
Total Methadone Trough Plasma Concentration
时间窗: Day 1, Day 7, Day 21
(R)-EDDP Trough Plasma Concentration
时间窗: Day 1, Day 7, Day 21
(S)- Methadone Trough Plasma Concentration
时间窗: Day 1, Day 7, Day 21
Total 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidene (EDDP) Peak Plasma Concentration
时间窗: Day 1, Day 7, Day 21
Total EDDP Trough Plasma Concentration
时间窗: Day 1, Day 7, Day 21
(S)-EDDP Trough Plasma Concentration
时间窗: Day 1, Day 7, Day 21
次要结局
未报告次要终点