Anti-Inflammatory Drug + Pain Challenge for Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that participants not be on any current medication treatment that would impact the measures of interest, so you may need to stop taking certain medications.
How does the Anti-Inflammatory Drug + Pain Challenge differ from other pain treatments?
This treatment is unique because it combines an anti-inflammatory drug with a pain challenge, which may help better understand the drug's effects on pain through a comprehensive assessment of pain-related behaviors and responses. Unlike traditional methods, this approach uses a multi-modal pain task battery to evaluate the drug's analgesic (pain-relieving) effects, potentially offering a more complete picture of its effectiveness.12345
What data supports the effectiveness of the drug anakinra (Kineret) for pain relief?
The research does not provide direct evidence for the effectiveness of anakinra (Kineret) in pain relief, but it discusses the importance of designing clinical trials to determine the efficacy of pain treatments. This suggests that well-designed trials are crucial for understanding the potential benefits of treatments like anakinra for pain.36789
Who Is on the Research Team?
Alan R Prossin, MD
Principal Investigator
The University of Texas Health Science Center, Houston
Are You a Good Fit for This Trial?
This trial is for healthy adults awaiting elective surgery, either obese or non-obese. They must not have had a PET scan in the past year, excessive lifetime radiation exposure, or any active severe medical conditions. Pregnant individuals or those with recent unprotected intercourse without contraception are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Experimental Pain Challenge
Participants undergo an experimental nociceptive pain challenge with mu-opioid receptor activity quantified via [11C]-carfentanil PET neuroimaging
Pharmacological Challenge
Participants receive anakinra or placebo to evaluate the effect on IL-1 cytokine activity and pain experience
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- anakinra
- Nociceptive pain challenge
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alan Prossin
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator