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The cytokines in the samples were undetectable.
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We aim to examine the extent to which inflammation is affected by acute and chronic opioid exposure.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Opioid Exposure | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine Sulfate | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Cytokine Release | 5 CCs of blood are drawn on day 1 and day 30. | Changes in cytokine release are compared between blood samples drawn on Day 1 and Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Changes in laser doppler images are measured between images taken on Day 1 and Day 30 |
| Peltier Device-Heat Pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Larry Fu-nien Chu | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
We were unable to perform analysis as we were unable to detect any cytokines in our samples.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Acute Opioid Exposure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Cytokine Release | 5 CCs of blood are drawn on day 1 and day 30. | 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. | Posted | Changes in cytokine release are compared between blood samples drawn on Day 1 and Day 30 |
|
As no data was collected for study measures, no adverse events data was collected.
There is no difference in definition. As no data was collected for study measures, no adverse events data was collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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We were unable to analyze any data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Larry F. Chu | Stanford University School of Medicine Department of Anesthesiology | 6507236632 | lchu@stanford.edu |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
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. |
| Differences in heat pain are assessed between measurements taken on Day 1 and Day 30 |
| Mechanical Pain Stimuli | Pain sensitivity will be tested with three different mechanical stimuli that can elicit mild pain:
| Changes in mechanical pain stimuli will be assessed between measurements taken on Day 1 and Day 30 |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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.
|
| 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. | 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. | Posted | Changes in laser doppler images are measured between images taken on Day 1 and Day 30 |
|
|
| 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. | 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. | Posted | Differences in heat pain are assessed between measurements taken on Day 1 and Day 30 |
|
|
| Secondary | Mechanical Pain Stimuli | Pain sensitivity will be tested with three different mechanical stimuli that can elicit mild pain:
| 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. | Posted | Changes in mechanical pain stimuli will be assessed between measurements taken on Day 1 and Day 30 |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 |
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| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |