Inflammatory Responses to Acute and Chronic Opioid Exposure in Humans
This study is currently recruiting participants.
Verified December 2012 by Stanford University
Sponsor:
Stanford University
Information provided by (Responsible Party):
Larry Fu-nien Chu, Stanford University
ClinicalTrials.gov Identifier:
NCT01749826
First received: November 9, 2009
Last updated: December 12, 2012
Last verified: December 2012
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Purpose
The PI is 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.
| Condition | Intervention |
|---|---|
|
Inflammation |
Drug: Morphine Sulfate |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Inflammatory Responses to Acute and Chronic Opioid Exposure in Humans |
Resource links provided by NLM:
Further study details as provided by Stanford University:
Primary Outcome Measures:
- Changes in Cytokine Release [ Time Frame: Changes in cytokine release are compared between blood samples drawn on Day 1 and Day 30 ] [ Designated as safety issue: No ]5 CCs of blood are drawn on day 1 and day 30.
Secondary Outcome Measures:
- Laser Doppler Images [ Time Frame: Changes in laser doppler images are measured between images taken on Day 1 and Day 30 ] [ Designated as safety issue: No ]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 [ Time Frame: Differences in heat pain are assessed between measurements taken on Day 1 and Day 30 ] [ Designated as safety issue: No ]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 [ Time Frame: Changes in mechanical pain stimuli will be assessed between measurements taken on Day 1 and Day 30 ] [ Designated as safety issue: No ]
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
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Chronic Opioid Exposure |
Drug: 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.
|
| Experimental: Acute Opioid Exposure |
Drug: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749826
Contacts
| Contact: Abigail K Zamora, BA | (650) 887-4677 | backpain@med.stanford.edu |
Locations
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Abigail K Zamora, BA 650-887-4677 backpain@med.stanford.edu | |
| Contact: Chelsea A Young, BS (650) 887-4677 backpain@med.stanford.edu | |
| Principal Investigator: Dr Larry Fu-nien Chu | |
Sponsors and Collaborators
Stanford University
Investigators
| Principal Investigator: | Dr Larry Fu-nien Chu | Stanford University |
More Information
No publications provided
| Responsible Party: | Larry Fu-nien Chu, Associate Professor of Anesthesia, Stanford University |
| ClinicalTrials.gov Identifier: | NCT01749826 History of Changes |
| Other Study ID Numbers: | SU-10212009-4201 |
| Study First Received: | November 9, 2009 |
| Last Updated: | December 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Inflammation Pathologic Processes Morphine Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on June 17, 2013