Opiate-Induced Tolerance & Hyperalgesia in Pain Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Pain Tolerance
研究概览
简要总结
Opiates such as morphine are the cornerstone medications for the treatment of moderate to severe pain. Recent evidence suggests that pain patients on chronic opioid therapy become more sensitive to pain (hyperalgesia) over time. There is also a long-standing notion that analgesic tolerance to opioids (habituation) develops during chronic use even though this phenomenon has never been prospectively studied. Our specific aims propose to prospectively test the hypotheses that; 1) Pain patients on chronic opioid therapy develop dose-dependent tolerance and/or hyperalgesia to these medications over time, 2) Opioid-induced tolerance and hyperalgesia develop differently with respect to various types of pain, 3) Opioid-induced hyperalgesia occurs independently of withdrawal phenomena, and 4) Opioid-induced tolerance and hyperalgesia develop differently based on gender and/or ethnicity. This proposed study will be the first quantitative and prospective study of tolerance and hyperalgesia in pain patients and will have important implications for the rational use of opioids in the treatment of chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
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
- •opioid naïve (or less than 4 vicodin equiv/day)
- •18-70 years old
- •candidate for opioid therapy for nonmalignant pain.
排除标准
- •history of substance abuse or severe psychiatric disease
- •use of medications for the treatment of neuropathic pain as these may alter tolerance or hyperalgesia
- •neurological conditions interfering with experimental pain testing, e.g. severe peripheral neuropathy
研究组 & 干预措施
1: Placebo Pill
This arm contains placebo medication.
干预措施: Placebo (Drug)
2: Morphine
Patients will receive oral morphine therapy.
干预措施: Morphine (Drug)
结局指标
主要结局
Pain Tolerance
时间窗: 1 month
Pain Threshold
时间窗: 1 month
次要结局
- Opioid Titration(1 month)
- Pain Intensity(1 month)
- Roland-Morris Disability Index(1 month)
- Beck Depression Inventory(1 month)
- Follow-Up Survey(1 year)
研究者
Dr. Lawrence Chu
National Institute of General Medical Sciences
Stanford University
