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Pain, Opioids and Pro-Inflammatory Immune Responses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01210066
Recruitment Status : Terminated (Unable to recruit prescription opioid abusers; ultimately no potential POA recruit passed the pre-screening process)
First Posted : September 28, 2010
Last Update Posted : December 29, 2016
Information provided by (Responsible Party):
University of California, Los Angeles

Brief Summary:
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 or disease Intervention/treatment Phase
Pro-inflammatory Activity Immunologic Activity Alteration Drug: Fentanyl Other: Cold pressor test Other: Fentanyl plus cold pressor test Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pain, Opioids and Pro-Inflammatory Immune Responses
Study Start Date : July 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Fentanyl

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. plasma levels of pro-inflammatory cytokine IL-6 [ Time Frame: 15 minutes prior to fentanyl administration, 60 and 180 minutes post fentanyl administration, ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01210066

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United States, California
UCLA School of Nursing
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
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Principal Investigator: Peggy A Compton, RN PhD FAAN University of California, Los Angeles
Publications of Results:
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Responsible Party: University of California, Los Angeles Identifier: NCT01210066    
Other Study ID Numbers: 5R21DA027558 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2010    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016
Keywords provided by University of California, Los Angeles:
opioid-induced hyperalgesia
prescription opioid abuse
Additional relevant MeSH terms:
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Vasoconstrictor Agents
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General