A Phase 1 interventional study of Fentanyl and Cold pressor test in Pro-inflammatory Activity and Immunologic Activity Alteration, sponsored by University of California, Los Angeles. Terminated at 1 site in United States. Open to participants aged 21 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-29.
Sponsored by University of California, Los Angeles · Phase 1, Interventional, and Basic science
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.
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.
University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
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Supplementary Inclusion Criteria: Prescription Opioid Abusers
Exclusion criteria:
Cold pressor test
Other: Cold pressor test
IV fentanyl 1mcg/kg followed by cold pressor test
Other: Fentanyl plus cold pressor test
Administration of fentanyl 1mcg/kg of subject weight
Drug: Fentanyl
IV fentanyl 1mcg/kg
Also known as: opioid
Non-dominant arm submerged in ice water (0 degrees Celsius) until it is no longer tolerable but less than 5 minutes
Also known as: cold pressor task
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)
Also known as: opioid and cold pressor
plasma levels of pro-inflammatory cytokine IL-6
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
Time frame: 15 minutes prior to fentanyl administration, 60 and 180 minutes post fentanyl administration,
This study is terminated, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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University of California, Los Angeles