Identifying pain-related bio-signatures for better pain management
Discovery and Analytical Validation of Inflammatory Bio-signatures of the Human Pain Experience
This study is testing a new way to predict pain after surgery by looking at how certain body signals change during pain and seeing if an anti-inflammatory drug can help manage that pain better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05074485 on ClinicalTrials.gov |
What this trial studies
This study aims to discover and validate a novel bio-signature derived from IL-1 family cytokine activity that can predict pain experiences and the release of endogenous opioids during a nociceptive pain challenge. Healthy subjects will undergo this challenge while their mu-opioid receptor activity is measured using PET neuroimaging. Additionally, the study will assess the effects of the anti-inflammatory drug minocycline on pain perception and cytokine balance. The ultimate goal is to create a reliable tool for predicting post-operative pain, particularly after elective cosmetic surgeries.
Who should consider this trial
Good fit: Ideal candidates are individuals awaiting elective surgery, regardless of obesity status, who meet the inclusion criteria.
Not a fit: Patients with active severe medical or psychiatric illnesses, or those with recent substance abuse issues, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective pain management strategies for patients undergoing surgery.
How similar studies have performed: While the approach of using bio-signatures for pain prediction is innovative, similar studies have shown promise in related areas, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Alan R Prossin, MD — The University of Texas Health Science Center, Houston
- Study coordinator: Alan R Prossin, MD
- Email: Alan.Prossin@uth.tmc.edu
- Phone: (713) 486-2836
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.