drugset / Trial / NCT05074485

Discovery and Analytical Validation of Inflammatory Bio-signatures of the Human Pain Experience

NCT05074485

RandomizedCrossoverOpen-labelBasic science

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.

Timeline

Start
2021-07-19
Primary completion
2026-05-07
Completion
2026-05-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Anakinra Protein / enzyme biologic 100 mg Intravenous

Indications

No indication recorded.