Inflammatory Responses to Acute and Chronic Opioid Exposure in Humans
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in Cytokine Release
研究概览
简要总结
We aim to examine the extent to which inflammation is affected by acute and chronic opioid exposure.
详细描述
We are interested in learning how the immune system and the inflammation process is effected by acute and chronic opioid exposure. Preliminary evidence in animal models show that acute opioid exposure leads to decreased inflammatory responses, while chronic opioid exposure causes increased inflammatory responses, as measured by local cytokine release at the site of injury. Translating these findings to humans will lead to important new mechanistic knowledge that may ultimately improve our ability to treat pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-60 years old
- •Healthy volunteer
- •Not allergic to remifentanil
排除标准
- •Patients younger than 18 or older than 70
- •Patients unwilling or unable to follow study instructions
- •Patients who don't speak English
- •Patients who are taking prescription opioid medications (e.g. vicodin, percocet) or are unwilling to refrain from taking anti-inflammatory medications such as Advil or Naproxen during 2 weeks prior to and during the 1 month study
研究组 & 干预措施
Chronic Opioid Exposure
15mg sustained release morphine sulfate, with a maximum dose of 120mg. Patients will be titrated up to a maximum dose of 8 pills a day for one month.
干预措施: Morphine Sulfate (Drug)
Acute Opioid Exposure
15mg sustained release morphine sulfate, with a maximum dose of 120mg. Patients will be titrated up to a maximum dose of 8 pills a day for one month.
干预措施: Morphine Sulfate (Drug)
结局指标
主要结局
Changes in Cytokine Release
时间窗: Changes in cytokine release are compared between blood samples drawn on Day 1 and Day 30
5 CCs of blood are drawn on day 1 and day 30.
次要结局
- Peltier Device-Heat Pain(Differences in heat pain are assessed between measurements taken on Day 1 and Day 30)
- Mechanical Pain Stimuli(Changes in mechanical pain stimuli will be assessed between measurements taken on Day 1 and Day 30)
- Laser Doppler Images(Changes in laser doppler images are measured between images taken on Day 1 and Day 30)
研究者
Larry Fu-nien Chu
Associate Professor of Anesthesia
Stanford University