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

Description

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.

Conditions

Pain

Study Overview

Study Details

Study overview

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.

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

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

Condition
Pain
Intervention / Treatment

-

Contacts and Locations

Houston

The University of Texas Health Science Center at Houston, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Obese or non-obese
  • * Awaiting elective surgery
  • * Negative urine pregnancy test
  • * 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Alan Prossin,

Alan R Prossin, MD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

2026-05-07