RecruitingPhase 1NCT05074485

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


Sponsor

Alan Prossin

Enrollment

70 participants

Start Date

Jul 19, 2021

Study Type

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

Min Age: 18 YearsMax Age: 65 Years

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGanakinra

intravenous injection of 100 milligrams anakinra

DRUGPlacebo

intravenous injection of 1 milliliter normal saline

OTHERNociceptive 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05074485


Related Trials