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Discovery and Analytical Validation of Inflammatory Bio-signatures of the Human Pain Experience
Sponsor: Alan Prossin
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.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2021-07-19
Completion Date
2026-05-07
Last Updated
2023-12-05
Healthy Volunteers
Yes
Conditions
Interventions
anakinra
intravenous injection of 100 milligrams anakinra
Placebo
intravenous injection of 1 milliliter normal saline
Nociceptive pain challenge
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)
The University of Texas Health Science Center at Houston
Houston, Texas, United States