Examining the Relationship Amongst Opioid Subjective Effects and Pharmacokinetics of Extended Release Opioids at Shortened Dosing Intervals in Patients With Chronic Pain: a Randomized, Blinded, N-of-1 Case Series Feasibility Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Percentage of participants who complete both treatment periods and have evaluable Patient Global Impression and pharmacokinetic data
研究概览
简要总结
This study is to determine the feasibility of an n-of-1, randomized, double blind, placebo controlled case series to examine effects of extended release opioids when used at intervals shorter than recommended by the manufacturer by people with chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •>18 years old
- •willing and capable to give written informed consent
- •diagnosis of chronic pain (> 3 months)
- •current prescription for oxycodone controlled release or hydromorphone controlled release or morphine sustained release for pain
- •Using extended release opioids at intervals less than 12 hours/ more than twice daily
排除标准
- •ongoing acute pain episode
- •use of immediate release opioids that contribute to more than 20% of their total daily opioid dose
- •total daily morphine equivalent dose >400mg
- •actively tapering their opioid dose
- •use of multiple extended release opioid products
- •unstable psychological diagnosis (using the Psychosocial Screening Interview Guide)
- •outstanding or planned litigation related to pain
- •pregnancy or lactation in women
- •history of coronary artery disease
- •active tapering or titration of benzodiazepines or cannabinoids
- •positive urine drug screen for amphetamines, barbiturates, cocaine, methamphetamine, methadone, phencyclidine, propoxyphene or unexpected opioids or benzodiazepines
- •using M-Eslon
- •using long acting hydromorphone
- •using Kadian
研究组 & 干预措施
Shortened interval extended release opioid
Extended release opioid, individualized total daily dose, dosing intervals less than every 12 hours.
干预措施: Extended Release Opioid Formulation, Shortened Intervals (Drug)
Shortened interval extended release opioid
Extended release opioid, individualized total daily dose, dosing intervals less than every 12 hours.
干预措施: Placebo oral tablet (Drug)
Standard interval extended release opioid
Extended release opioid, individualized total daily dose, dosing intervals every 12 hours
干预措施: Extended Release Opioid Formulation, Standard intervals (Drug)
Standard interval extended release opioid
Extended release opioid, individualized total daily dose, dosing intervals every 12 hours
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Percentage of participants who complete both treatment periods and have evaluable Patient Global Impression and pharmacokinetic data
时间窗: 8 months
Feasibility outcome
次要结局
- Patient Global Impression of Change(3 weeks)
- Numerical Pain Rating Scale(3 weeks)
- Brief Pain Inventory (Short Form)(3 weeks)
- Subjective Opioid Withdrawal Scale(3 weeks)
- Addiction Research Centre Inventory (ARCI) - short form(8 hours)
- Profile of Mood States(8 hours)
- Visual analogue scale - liking/high(8 hours)
- Serum opioid concentrations(6 hours)
- Peak plasma concentration (Cmax)(6 hours)
- Time to peak plasma concentration (Tmax)(6 hours)
- Area under the plasma concentration versus time curve (AUC)(24 hours)
- Abuse liability quotient (AQ)(6 hours)