The Study of Potential Normalization of Cardiac Rhythm Following Drug Exchange From Chimeric Methadone to Active Methadone
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Effects of switching from racemic methadone to R-methadone on serum methadone concentrations.
研究概览
简要总结
Effects of switching from racemic methadone to R-methadone on serum methadone concentrations and QTc intervals
详细描述
Racemic methadone may prolong the QTc interval, which is associated with fatal arrhythmias. In vitro studies have shown that R-methadone has less inhibitory effect than S-methadone on the voltage-gated potassium channel current, and is thus thought to have less effect on the QTc interval.
The investigators hypothesized that switching from racemic to R-methadone would reduce the methadone serum concentration and also its effect on the QTc interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stabilized on daily methadone dose
- •Not using other drugs of abuse
- •QTc-time recorded automatically, patient inclusion if QTc interval was greater or equal to 450 ms
- •Older than 18 years
- •Can sign and understand a written Consent
排除标准
- •Can not cooperate regarding observed daily drug intake
- •Serious psychiatric disease
- •Untreated serious somatic disease
- •Pregnancy
研究组 & 干预措施
Cross over study before and after drug switch
Stabilized on racemic methadone dose, switched to R-methadone of half racemic methadone dose. Cross over study, own control
干预措施: Same individuals treated with racemic methadone and switched to levomethadone (R-methadone) (Drug)
结局指标
主要结局
Effects of switching from racemic methadone to R-methadone on serum methadone concentrations.
时间窗: Time frame of each patient form inclusion to end study was 35-40 days.
Ten patients stabilized on racemic methadone dose were switched to R-methadone and effects on serum methadone concentrations were studied. Methadone concentrations (nmol/L) were measured by validated high pressure liquid chromatography coupled to mass spectrometry detection (LC-MSMS).
Effects of switching from racemic methadone to R-methadone on QTc interval
时间窗: Time frame of each patient form inclusion to end study was 35-40 days.
In ten patients QTc intervals were recorded on racemic methadone treatment at Cmin and Cmax of methadone drug concentrations and likewise after the shift to R-methadone. QT intervals (ms) on ECG were recorded automatically and read manually by experienced cardiologists.
Effects of switching from racemic methadone to R-methadone on opioid withdrawal symptoms (OWS)
时间窗: Time frame of each patient form inclusion to end study was 35-40 days.
Ten patients: each patients had OWS recorded on racemic and R-methadone treatment using OWS.
Effects of switching from racemic methadone to R-methadone, stability of serum electrolytes (Ca, Mg, K) in patients
时间窗: Time frame of each patient form inclusion to end study was 35-40 days.
Ten patients: samples for serum electrolytes were collected before and after switch to R-methadone. Measured by routine analysis at Cobas 8000 (unit mmol/L)
次要结局
未报告次要终点
研究者
Mimi Stokke Opdal
Senior Consultant and Associate Professor of Clinical Pharmacology
Oslo University Hospital