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

• Status: Recruiting
• Trial end date: 2026-05-07
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alan Prossin
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

• Obese or non-obese

• Awaiting elective surgery

• Negative urine pregnancy test

Exclusion Criteria:

• 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).

• MRI exclusion criteria including presence of non-MRI-safe medical device(s), magnetizable objects in soft tissue, severe claustrophobia, etc.

• 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

• Exclusion criteria for Anakinra treatment.