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Anti-Inflammatory Drug + Pain Challenge for Pain

Phase 1
Recruiting
Led By Alan R Prossin, MD
Research Sponsored by Alan Prossin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Awaiting elective surgery
Obese or non-obese
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 to 8 weeks after elective surgery
Awards & highlights

Study Summary

This trial will study whether a new bio-signature (a range of pro- and anti-nociceptive IL-1 family cytokine activity) can predict pain and release of endogenous opioids in healthy subjects. Another objective is to see if an anti-inflammatory drug (minocycline) will reduce pain during the experimental, nociceptive pain challenge.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include typical reactions to minocycline such as dizziness, fatigue, gastrointestinal discomfort, and skin reactions. The placebo group should not experience medication-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a planned surgery.
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My weight status is either obese or non-obese.
Select...
I am scheduled for an upcoming surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 to 8 weeks after elective surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 to 8 weeks after elective surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain as assessed by total pain score on the McGill Pain Questionnaire

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo plus nociceptive pain challenge, then anakinra plus nociceptive pain challengeExperimental Treatment3 Interventions
Pharmacological challenge (with placebo) plus nociceptive pain challenge, then pharmacological challenge (with anakinra) plus nociceptive pain challenge
Group II: Anakinra plus nociceptive pain challenge, then placebo plus nociceptive pain challengeExperimental Treatment3 Interventions
Pharmacological challenge (with anakinra) plus nociceptive pain challenge, then pharmacological challenge (with placebo) plus nociceptive pain challenge
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
anakinra
2012
Completed Phase 3
~240

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Alan ProssinLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,337 Previous Clinical Trials
648,774 Total Patients Enrolled
17 Trials studying Pain
3,545 Patients Enrolled for Pain
Alan R Prossin, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

Pain Research Study Groups: Anakinra plus nociceptive pain challenge, then placebo plus nociceptive pain challenge, Placebo plus nociceptive pain challenge, then anakinra plus nociceptive pain challenge

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age cap for participants in this research?

"Enrollees of this study must be over 18 years old and below the age of 65."

Answered by AI

Could you provide a synopsis of the research conducted in regards to Nociceptive pain stimulation?

"Presently, there are 33 investigations into Nociceptive pain challenge; 7 of those studies have reached Phase 3. Over 440 trial locations exist globally with the majority being within Paris, Ile-De-France."

Answered by AI

To what ailments does Nociceptive pain challenge typically offer relief?

"Nociceptive pain challenge is a popular approach for treating Systemic Juvenile Idiopathic Arthritis (sjia), but it may also be effective in managing Neonatal-Onset Multisystem Inflammatory Disease (nomid) and other conditions involving interleukin-1 receptors or steroids."

Answered by AI

To what degree is Nociceptive pain challenge a secure treatment for patients?

"Our team has judged the safety of Nociceptive pain challenge as moderately low, given that this Phase 1 trial contains a limited amount of data regarding its efficacy and safety."

Answered by AI

Do I qualify to partake in this clinical experiment?

"This medical research is searching for 70 people aged 18 to 65 that are experiencing pain. Notably, the trial participants must be either obese or non-obese and they should have an upcoming elective surgical procedure."

Answered by AI

How many participants have signed up for this experiment?

"Affirmative. According to the data uploaded on clinicaltrials.gov, this trial began accepting applicants on 19th of July 2021 and has since been revised once as of January 19th 2022. The research necessitates 70 participants recruited from one location only."

Answered by AI

Are there current openings for participants in this research endeavor?

"Affirmative. Clinicaltrials.gov reveals that this clinical investigation, which was initially publicized on July 19th 2021, is now recruiting volunteers. Approximately 70 people are required to be recruited from one location."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
The University of Texas Health Science Center at Houston
How many prior treatments have patients received?
1
~31 spots leftby May 2026