Trial Outcomes & Findings for Inflammatory Responses to Acute and Chronic Opioid Exposure in Humans (NCT NCT01749826)
NCT ID: NCT01749826
Last Updated: 2019-01-30
Results Overview
5 CCs of blood are drawn on day 1 and day 30.
TERMINATED
NA
20 participants
Changes in cytokine release are compared between blood samples drawn on Day 1 and Day 30
2019-01-30
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
20
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Study Terminated
|
20
|
0
|
Baseline Characteristics
Inflammatory Responses to Acute and Chronic Opioid Exposure in Humans
Baseline characteristics by cohort
| Measure |
Chronic Opioid Exposure
n=20 Participants
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.
|
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.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 11.47 • n=5 Participants
|
—
|
40.9 years
STANDARD_DEVIATION 11.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
—
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
—
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
—
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
—
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Changes in cytokine release are compared between blood samples drawn on Day 1 and Day 30Population: 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.
5 CCs of blood are drawn on day 1 and day 30.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Changes in laser doppler images are measured between images taken on Day 1 and Day 30Population: 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.
The laser doppler is a noninvasive, painless measurement of superficial perfusion that reflects inflammation. Laser doppler images will be taken once per study visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Differences in heat pain are assessed between measurements taken on Day 1 and Day 30Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Changes in mechanical pain stimuli will be assessed between measurements taken on Day 1 and Day 30Population: 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.
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
Outcome measures
Outcome data not reported
Adverse Events
Chronic Opioid Exposure
Acute Opioid Exposure
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Larry F. Chu
Stanford University School of Medicine Department of Anesthesiology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place