70 Participants Needed

Anti-Inflammatory Drug + Pain Challenge for Pain

AR
Overseen ByAlan R Prossin, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

AR

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

I am scheduled for a planned surgery.
My weight status is either obese or non-obese.
Negative urine pregnancy test

Exclusion Criteria

Recent (past year) PET scan(s)
You have used illegal drugs or abused alcohol in the past three months. However, if you use nicotine or drink alcohol in moderation, it's okay.
I do not have any severe mental or physical health conditions.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Pain Challenge

Participants undergo an experimental nociceptive pain challenge with mu-opioid receptor activity quantified via [11C]-carfentanil PET neuroimaging

1 week
1 visit (in-person)

Pharmacological Challenge

Participants receive anakinra or placebo to evaluate the effect on IL-1 cytokine activity and pain experience

2 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 to 8 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • anakinra
  • Nociceptive pain challenge
  • Placebo
Trial Overview The study aims to identify bio-signatures predicting pain and opioid neurotransmitter release during a controlled pain challenge. It will also test if an anti-inflammatory drug (minocycline) affects these bio-signatures and post-operative pain levels using [11C]-carfentanil PET neuroimaging.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Placebo plus nociceptive pain challenge, then anakinra plus nociceptive pain challengeExperimental Treatment3 Interventions
Group II: Anakinra plus nociceptive pain challenge, then placebo plus nociceptive pain challengeExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alan Prossin

Lead Sponsor

Trials
1
Recruited
70+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Published Research Related to This Trial

In a study of 25 healthy volunteers, both acetaminophen and the combination of acetaminophen with hydrocodone showed similar effectiveness in reducing perceived pain from a cold water stimulus, with decreases of 10.2% and 9.5% respectively.
Ibuprofen and placebo did not significantly reduce pain, indicating that in this noninflammatory pain model, the pain relief provided by acetaminophen and acetaminophen/hydrocodone was not distinguishable from each other, while mild side effects were reported in 44% of subjects taking acetaminophen/hydrocodone.
Randomized double-blind placebo controlled crossover study of acetaminophen, ibuprofen, acetaminophen/hydrocodone, and placebo for the relief of pain from a standard painful stimulus.Miner, JR.[2013]
Proof-of-concept (POC) clinical trials are crucial for assessing the potential efficacy of new and existing pain treatments, helping to determine whether they should proceed to larger confirmatory trials.
The IMMPACT consensus meeting highlighted the importance of efficient trial designs, such as adaptive and N-of-1 designs, to maximize statistical power while minimizing costs and participant exposure, ultimately aiming to improve the success rate of effective pain treatments in clinical development.
Research designs for proof-of-concept chronic pain clinical trials: IMMPACT recommendations.Gewandter, JS., Dworkin, RH., Turk, DC., et al.[2023]
A systematic review and meta-analysis of 27 randomized clinical trials involving various chronic pain conditions found no significant difference in assay sensitivity between average pain intensity (API) and worst pain intensity (WPI) as primary outcome measures.
This suggests that either API or WPI can be effectively used in clinical trials for assessing the efficacy of pain treatments, allowing researchers flexibility based on their study objectives.
A Comparison of the Assay Sensitivity of Average and Worst Pain Intensity in Pharmacologic Trials: An ACTTION Systematic Review and Meta-Analysis.Smith, SM., Jensen, MP., He, H., et al.[2019]

Citations

Randomized double-blind placebo controlled crossover study of acetaminophen, ibuprofen, acetaminophen/hydrocodone, and placebo for the relief of pain from a standard painful stimulus. [2013]
Research designs for proof-of-concept chronic pain clinical trials: IMMPACT recommendations. [2023]
A Comparison of the Assay Sensitivity of Average and Worst Pain Intensity in Pharmacologic Trials: An ACTTION Systematic Review and Meta-Analysis. [2019]
4.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Emodin Reduces Inflammatory and Nociceptive Responses in Different Pain-and Inflammation-Induced Mouse Models. [2023]
Advances with analgesics and NSAIDs for the treatment of spinal disorders. [2005]
Determining Pain Detection and Tolerance Thresholds Using an Integrated, Multi-Modal Pain Task Battery. [2018]
Locomotor activity in a novel environment as a test of inflammatory pain in rats. [2022]
Preclinical Pharmacological Approaches in Drug Discovery for Chronic Pain. [2016]
Preclinical assessment of candidate analgesic drugs: recent advances and future challenges. [2016]
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