Pain, Opioids and Pro-Inflammatory Immune Responses

December 27, 2016 updated by: University of California, Los Angeles
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • opioid and cold pressor
Active Comparator: Opioid Challenge
Administration of fentanyl 1mcg/kg of subject weight
Drug: Fentanyl
IV fentanyl 1mcg/kg
Other Names:
  • opioid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
15 minutes prior to fentanyl administration, 60 and 180 minutes post fentanyl administration,

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: Peggy A Compton, RN PhD FAAN, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

September 27, 2010

First Submitted That Met QC Criteria

September 27, 2010

First Posted (Estimate)

September 28, 2010

Study Record Updates

Last Update Posted (Estimate)

December 29, 2016

Last Update Submitted That Met QC Criteria

December 27, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5R21DA027558 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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