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Pain, Opioids and Pro-Inflammatory Immune Responses

This study is currently recruiting participants.
Verified February 2012 by University of California, Los Angeles
Sponsor:
Information provided by (Responsible Party):
Peggy Compton, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01210066
First received: September 27, 2010
Last updated: February 4, 2012
Last verified: February 2012
History of Changes
  Purpose

Providing pain management to the patient who abuses prescription opioids presents a clinical challenge, not only due to concerns about "drug-seeking", but because they have increased sensitivity to pain, a phenomenon identified as opioid-induced hyperalgesia (OIH). In an effort to improve pain treatment, the aims of the proposed work are to evaluate the analgesic and hyperalgesic effects of opioids to acute pain in this vulnerable population, and to examine the role of opioid-induced proinflammatory changes in these responses.


Condition Intervention Phase
Pro-inflammatory Activity
Immunologic Activity Alteration [PE]
 Drug: Fentanyl
Other: Cold pressor test
Other: Fentanyl plus cold pressor test
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pain, Opioids and Pro-Inflammatory Immune Responses

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • plasma levels of pro-inflammatory cytokine IL-6 [ Time Frame: 15 minutes prior to fentanyl administration, 60 and 180 minutes post fentanyl administration, ] [ Designated as safety issue: No ]
    inflammatory cytokine activity will be evaluated with an in vivo approach over a three hour period of time to enable observation of the duration of opioid activity


Estimated Enrollment: 44
Study Start Date: July 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pain Challenge
Cold pressor test
 Other: Cold pressor test
Non-dominant arm submerged in ice water (0 degrees Celsius) until it is no longer tolerable but less than 5 minutes
Other Name: cold pressor task
Active Comparator: Pain + Opioid Challenge
IV fentanyl 1mcg/kg followed by cold pressor test
 Other: Fentanyl plus cold pressor test
fentanyl IV 1mcg/kg fifteen minutes prior to cold pressor test (arm submerged in ice water until no longer tolerable but no longer than 5 minutes)
Other Name: opioid and cold pressor
Active Comparator: Opioid Challenge
Administration of fentanyl 1mcg/kg of subject weight
 Drug: Fentanyl
IV fentanyl 1mcg/kg
Other Name: opioid

Detailed Description:

Both acute pain and opioid administration have been shown to induce a systemic pro-inflammatory response. However, the presence of these inflammatory responses is unknown in situations where a co-occurrence of pain and opioid administration exists as is the common clinical case of a patient with acute pain and taking opioid analgesics. A patient population for whom the combined effects of pain and opioids on immune function are particularly complex are the estimated 5.2 million Americans aged 12 or older who abuse prescription opioids. Not only are these individuals at risk for poor pain management due to their status as an "addict", but there is good preclinical evidence to suggest that their chronic opioid use brings with it a general state of systemic inflammation, and thus setting the patient up for a unique or enhanced inflammatory response to the combination of acute opioids and pain. To better understand the health implications of treating acute pain with opioids in patients and in particular, those who abuse prescription opioids, inflammatory responses to the main and interaction effects of acute pain and opioid administration will be examined in well-characterized samples of each. Specifically, we will evaluate the inflammatory and cytokine responses to: (1) experimental pain; (2) an acute opioid challenge; and (3) the combination of opioid administration followed by cold-pressor pain, in healthy control subjects and age- and gender-matched prescription opioid abusers.

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • male and non-pregnant female, non-smoking adults in good general health
  • between the ages of 21-40 years old
  • fluent in English with willingness to participate in the research study

Supplementary Inclusion Criteria: Prescription Opioid Abusers

  • DSM-IVR diagnosis of prescription opioid abuse or dependence disorder
  • compliance in treatment and on a stable dose of buprenorphine (6-24mg/day) x at least 10 days prior to screening
  • Participation in an ISAP treatment program or a qualified community-based opioid treatment program or private clinic for the entire duration of their study participation

Exclusion criteria:

  • regular use of any medication that influences immune status or immune system function
  • regular use of a medication that influences pain perception, including opioids (* only for healthy subjects population*)
  • Regular use of a medication that influences pain perception, except for buprenorphine (** only for POA population**)
  • known hypersensitivity to opioids or no previous opioid exposure (*only healthy controls)
  • presence of acute or chronic pain syndrome
  • neuropsychiatric illness (i.e., peripheral neuropathy, schizophrenia) known to affect pain perception
  • presence of chronic immune compromise (hepatitis C, HIV) or acute infection within the last four weeks
  • current or past history of high blood pressure, heart disease, or stroke, or currently have a pacemaker.
  • current DSM-IV diagnosis
  • BMI less than 18.5 or greater than 29.9
  • History of sleep apnea
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01210066

Locations
United States, California
UCLA School of Nursing Recruiting
Los Angeles, California, United States, 90095
Contact: Kelly Hickey     310-794-4429     khickey@sonnet.ucla.edu    
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Peggy A Compton, RN PhD FAAN University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Peggy Compton, Professor, Associate Dean for Academic Affairs, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01210066     History of Changes
Other Study ID Numbers: 5R21DA27558
Study First Received: September 27, 2010
Last Updated: February 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:
inflammation
opioid-induced hyperalgesia
bupenorphine
prescription opioid abuse

Additional relevant MeSH terms:
Fentanyl
Analgesics, Opioid
Vasoconstrictor Agents
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
 Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013