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临床试验/NCT00246532
NCT00246532已完成4 期

Opiate-Induced Tolerance & Hyperalgesia in Pain Patients

National Institute of General Medical Sciences (NIGMS)1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2005年10月最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

This arm contains placebo medication.

干预措施: Placebo (Drug)

2: Morphine

Active Comparator

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

发起方
National Institute of General Medical Sciences (NIGMS)
申办方类型
Nih
责任方
Principal Investigator
主要研究者

Dr. Lawrence Chu

National Institute of General Medical Sciences

Stanford University

研究点 (1)

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