Discovery and Analytical Validation of Inflammatory Bio-signatures of the Human Pain Experience
Status:
Recruiting
Trial end date:
2026-05-07
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Alan Prossin
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)