Inflammatory Responses to Acute and Chronic Opioid Exposure in Humans
Overview
- Phase
- Not Applicable
- Intervention
- Morphine Sulfate
- Conditions
- Inflammation
- Sponsor
- Stanford University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Changes in Cytokine Release
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
We aim to examine the extent to which inflammation is affected by acute and chronic opioid exposure.
Detailed Description
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.
Investigators
Larry Fu-nien Chu
Associate Professor of Anesthesia
Stanford University
Eligibility Criteria
Inclusion Criteria
- •18-60 years old
- •Healthy volunteer
- •Not allergic to remifentanil
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Morphine Sulfate
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.
Intervention: Morphine Sulfate
Outcomes
Primary Outcomes
Changes in Cytokine Release
Time Frame: 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.
Secondary Outcomes
- 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)