Inflammation
Conditions
Keywords
Inflammation, opioids, immune system
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.
Interventions
DRUGMorphine Sulfate
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.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Cytokine Release | 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
| Measure | Time frame | Description |
|---|---|---|
| Laser Doppler Images | Changes in laser doppler images are measured between images taken on Day 1 and Day 30 | The laser doppler is a noninvasive, painless measurement of superficial perfusion that reflects inflammation. Laser doppler images will be taken once per study visit. |
| Peltier Device-Heat Pain | Differences in heat pain are assessed between measurements taken on Day 1 and Day 30 | A hand-held 0.6x0.6 inch metal probe will be brought into contact with the patient's skin. Starting at 95 F, the probe temperature will increase at a rate of 1.8 F per second. The patient will be asked to push a button of a hand-held device as soon as the patient feels pain. |
| Mechanical Pain Stimuli | Changes in mechanical pain stimuli will be assessed between measurements taken on Day 1 and Day 30 | Pain sensitivity will be tested with three different mechanical stimuli that can elicit mild pain: * Stroking stimulus: skin will be tested with a brush that is moved three times across the lesion * Punctuated stimulus: a metal rod (1/100 of an inch in diameter) mounted onto 10 different weights (0.03-2.9 ounces) will repetitively be placed onto the skin * Blunt stimulus: a flat probe (0.4 inch in diameter) will be placed five times onto the patient's skin |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chronic Opioid Exposure Morphine Sulfate: 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. | 20 |
| Acute Opioid Exposure Morphine Sulfate: 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. | 0 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study Terminated | 20 | 0 |
Baseline characteristics
| Characteristic | Chronic Opioid Exposure | Total |
|---|---|---|
| Age, Continuous | 40.9 years STANDARD_DEVIATION 11.47 | 40.9 years STANDARD_DEVIATION 11.47 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 14 Participants |
| Region of Enrollment United States | 20 participants | 20 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Changes in Cytokine Release
5 CCs of blood are drawn on day 1 and day 30.
Time frame: Changes in cytokine release are compared between blood samples drawn on Day 1 and Day 30
Population: Data can not be summarized or included in this table as no data on this measure was collected. 5 CCs of blood were not drawn from any participants at any point in time during the study as the study was terminated due to a lack of resources prior to collection of any study measure data.
Secondary
Laser Doppler Images
The laser doppler is a noninvasive, painless measurement of superficial perfusion that reflects inflammation. Laser doppler images will be taken once per study visit.
Time frame: Changes in laser doppler images are measured between images taken on Day 1 and Day 30
Population: Data can not be summarized or included in this table as no data on this measure was collected. Laser doppler image data was not collected from any participants at any point in time during the study as the study was terminated due to a lack of resources prior to collection of any study measure data.
Secondary
Mechanical Pain Stimuli
Pain sensitivity will be tested with three different mechanical stimuli that can elicit mild pain: * Stroking stimulus: skin will be tested with a brush that is moved three times across the lesion * Punctuated stimulus: a metal rod (1/100 of an inch in diameter) mounted onto 10 different weights (0.03-2.9 ounces) will repetitively be placed onto the skin * Blunt stimulus: a flat probe (0.4 inch in diameter) will be placed five times onto the patient's skin
Time frame: Changes in mechanical pain stimuli will be assessed between measurements taken on Day 1 and Day 30
Population: Data can not be summarized or included in this table as no data on this measure was collected. Mechanical pain stimuli data was not collected from any participants at any point in time during the study as the study was terminated due to a lack of resources prior to collection of any study measure data.
Secondary
Peltier Device-Heat Pain
A hand-held 0.6x0.6 inch metal probe will be brought into contact with the patient's skin. Starting at 95 F, the probe temperature will increase at a rate of 1.8 F per second. The patient will be asked to push a button of a hand-held device as soon as the patient feels pain.
Time frame: Differences in heat pain are assessed between measurements taken on Day 1 and Day 30
Population: Data can not be summarized or included in this table as no data on this measure was collected. Peltier device-heat pain data was not collected from any participants at any point in time during the study as the study was terminated due to a lack of resources prior to collection of any study measure data.