Discovery and Analytical Validation of Inflammatory Bio-signatures of the Human Pain Experience
Alan Prossin
70 participants
Jul 19, 2021
INTERVENTIONAL
Conditions
Summary
The first objective of the study is to evaluate whether a novel bio-signature (derived from a wide range of pro- and anti-nociceptive IL-1 family cytokine activity) will predict pain experienced and also release of underlying endogenous opioid neurotransmitters during an experimental nociceptive pain challenge, which will be performed while simultaneously quantifying mu-opioid receptor activity in the brain via \[11C\]-carfentanil PET neuroimaging in healthy subjects. Another objective is to evaluate whether an anti-inflammatory drug that reduces activation of IL-1b (minocycline) will perturb the balance between pro- and anti-nociceptive IL-1 cytokines and effect a reduction in pain experienced (and endogenous opioids released) during the experimental, nociceptive pain challenge. A final objective is to evaluate performance characteristics (sensitivity, accuracy, dynamic range) of the biosignature for the purpose of predicting post-operative pain.
Eligibility
Inclusion Criteria3
- Obese or non-obese
- Awaiting elective surgery
- Negative urine pregnancy test
Exclusion Criteria9
- Active, severe medical or psychiatric illness (per DSM-V)
- History of depressive and/or anxiety symptoms with or without presence of a DSM-V depressive and/or anxiety disorder
- Current or recent (within past 3 months) suicidal thoughts/plans/attempts
- Current or recent (within past 3 months) substance use/abuse/dependence (Note: stable nicotine use is acceptable, non-risky alcohol use is acceptable)
- Active or chronic medical illness (except obesity: either obese or non-obese volunteers can enroll in the study).
- Recent (past year) PET scan(s).
- Lifetime excessive radiation exposure that would be exclusionary via standards of the local radiation safety committee.
- Current medication treatment that would impact measures of interest.
- Current pregnancy or recent (within the past 2 months) intercourse without an acceptable contraceptive method
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Interventions
intravenous injection of 100 milligrams anakinra
intravenous injection of 1 milliliter normal saline
The experimental, standardized, nociceptive pain challenge will induce a moderate level of sustained pain. The pain challenge involves a masseteric injection in the left or right jaw muscle of normal saline (0.15 ml bolus of 0.9% normal saline) over a 15 second period followed by continuous infusion via a closed loop infusion system for 20 minutes.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05074485