Inflammatory Responses to Acute and Chronic Opioid Exposure in Humans

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Stanford University
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014