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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• Obese or non-obese

• Awaiting elective surgery

• Negative urine pregnancy test

Locations
United States
Texas
The University of Texas Health Science Center at Houston
RECRUITING
Houston
Contact Information
Primary
Alan R Prossin, MD
Alan.Prossin@uth.tmc.edu
(713) 486-2836
Time Frame
Start Date: 2021-07-19
Estimated Completion Date: 2026-05-07
Participants
Target number of participants: 70
Treatments
Experimental: Placebo plus nociceptive pain challenge, then anakinra plus nociceptive pain challenge
Pharmacological challenge (with placebo) plus nociceptive pain challenge, then pharmacological challenge (with anakinra) plus nociceptive pain challenge
Experimental: Anakinra plus nociceptive pain challenge, then placebo plus nociceptive pain challenge
Pharmacological challenge (with anakinra) plus nociceptive pain challenge, then pharmacological challenge (with placebo) plus nociceptive pain challenge
Related Therapeutic Areas
Sponsors
Leads: Alan Prossin
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov