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Pain, Opioids and Pro-Inflammatory Immune Responses

NCT ID: NCT01210066

Last Updated: 2016-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pro-inflammatory Activity Immunologic Activity Alteration

Keywords

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inflammation opioid-induced hyperalgesia bupenorphine prescription opioid abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Pain Challenge

Cold pressor test

Group Type ACTIVE_COMPARATOR

Cold pressor test

Intervention Type OTHER

Non-dominant arm submerged in ice water (0 degrees Celsius) until it is no longer tolerable but less than 5 minutes

Pain + Opioid Challenge

IV fentanyl 1mcg/kg followed by cold pressor test

Group Type ACTIVE_COMPARATOR

Fentanyl plus cold pressor test

Intervention Type OTHER

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)

Opioid Challenge

Administration of fentanyl 1mcg/kg of subject weight

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

IV fentanyl 1mcg/kg

Interventions

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Fentanyl

IV fentanyl 1mcg/kg

Intervention Type DRUG

Cold pressor test

Non-dominant arm submerged in ice water (0 degrees Celsius) until it is no longer tolerable but less than 5 minutes

Intervention Type 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)

Intervention Type OTHER

Other Intervention Names

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opioid cold pressor task opioid and cold pressor

Eligibility Criteria

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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


* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peggy A Compton, RN PhD FAAN

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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UCLA School of Nursing

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Compton P, Griffis C, Breen EC, Torrington M, Sadakane R, Tefera E, Irwin MR. Opioid treatment of experimental pain activates nuclear factor-kappaB. J Opioid Manag. 2015 Mar-Apr;11(2):115-25. doi: 10.5055/jom.2015.0261.

Reference Type RESULT
PMID: 25901477 (View on PubMed)

Other Identifiers

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5R21DA027558

Identifier Type: NIH

Identifier Source: org_study_id

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