RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-07-19
Study Completion:2026-05-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05074485

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Obese or non-obese
  2. * Awaiting elective surgery
  3. * Negative urine pregnancy test
  1. * Active, severe medical or psychiatric illness (per DSM-V)
  2. * History of depressive and/or anxiety symptoms with or without presence of a DSM-V depressive and/or anxiety disorder
  3. * Current or recent (within past 3 months) suicidal thoughts/plans/attempts
  4. * Current or recent (within past 3 months) substance use/abuse/dependence (Note: stable nicotine use is acceptable, non-risky alcohol use is acceptable)
  5. * Active or chronic medical illness (except obesity: either obese or non-obese volunteers can enroll in the study).
  6. * MRI exclusion criteria including presence of non-MRI-safe medical device(s), magnetizable objects in soft tissue, severe claustrophobia, etc.
  7. * Recent (past year) PET scan(s).
  8. * Lifetime excessive radiation exposure that would be exclusionary via standards of the local radiation safety committee.
  9. * Current medication treatment that would impact measures of interest.
  10. * Current pregnancy or recent (within the past 2 months) intercourse without an acceptable contraceptive method
  11. * Exclusion criteria for Anakinra treatment.

Contacts and Locations

Study Contact

Alan R Prossin, MD
CONTACT
(713) 486-2836
Alan.Prossin@uth.tmc.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Alan Prossin

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-19
Study Completion Date2026-05-07

Study Record Updates

Study Start Date2021-07-19
Study Completion Date2026-05-07

Terms related to this study

Additional Relevant MeSH Terms

  • Pain