New pain test battery could speed up drug development
NCT ID NCT07549490
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 58 times
Summary
This pilot study will test a new method to see how two pain medicines, naproxen and pregabalin, work in healthy adults. Up to 25 participants will receive each medicine and a placebo in random order. They will undergo several short, controlled pain tests, like a cold water hand bath and a temporary sunburn-like skin sensitivity. The goal is to see if this testing approach can tell the difference between medicines that work in the brain versus those that reduce inflammation. This study is not expected to help participants directly but may improve how future pain treatments are tested.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- naproxen and pregabalin
- What this could lead to
- If successful, this approach could help researchers test new pain treatments more efficiently in early studies.
- What could go wrong
- This is a very small pilot study in healthy adults, not patients. It is designed to test a method, not to prove any treatment works.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: For an individual to be eligible to participate in this study, they must meet all of the following criteria: * Voluntarily consent to participate and provide written informed consent prior to the start of any study-specific procedures. * Read and speak English fluently. * State willingness to comply with all study procedures and availability for the duration of the study. * Are not pregnant or breastfeeding. * Are 18 or older years of age at screening. * Have a skin type score between 2 and 5 (inclusive) on the Fitzpatrick Scale. * Must correctly identify at least nine out of 12 temperatures (32 degrees Celsius, 38 degrees Celsius, 44 degrees Celsius, and 50 degrees Celsius, each presented three times) during the sensory discrimination test at screening. * Provide a verbal pain rating between 4 and 9 (inclusive) during the intradermal capsaicin challenge at screening. The study team will verify tolerability, and participants will continue only after it has been confirmed. * During the cold pressor test at screening, provide a verbal pain rating between 4 and 9 (inclusive) and keep one hand completely immersed in ice-cold water (1-4 degrees Celsius) between 1 and 4 minutes (inclusive). The study team will verify tolerability, and participants will continue only after it has been confirmed. * Are able to learn and perform all quantitative sensory testing QST procedures (see the separate QST manual). * Have the ability to take oral medication and be willing to adhere to the study intervention regimen. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: * Have a history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the participant or the validity of the study results. * Have alcohol or drug dependence (excluding nicotine and caffeine) within the past 2 years, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM IV-TR) and/or participants who have ever been in a substance or alcohol rehabilitation program to treat their substance dependence are currently seeking such treatment. * Have a clinically significant abnormal finding on the physical exam, medical history, or clinical laboratory results at screening. * Have a history of psychotic reactions, a non-psychotic emotional disorder, or another mental illness that, in the opinion of the investigator, may affect the ability of the participant to participate in the study. * Have recent history of suicidal ideation or suicidal behavior within the past 6 months, as assessed by the Columbia- Suicide Severity Rating Scale (C-SSRS) at screening (baseline version) or at check-in ( Since Last Visit version). * Have a history of allergy or hypersensitivity to pregabalin or other gabapentinoids, naproxen or other NSAIDs, or another ingredient in the study drugs, or anything else that, in the opinion of the Investigator, could put the participant at risk. * Have participated in another clinical trial (randomized participants only) within 30 days prior to the first dose of study medication. * Use any prescription medication, except hormonal contraceptive or hormonal replacement therapy, from 14 days prior to the first dose of study medication until study participation has ended without evaluation and approval by the Investigator. * Donate blood or plasma within 30 days prior to the first dose of study medication until the end of study participation. It is recommended that participants not donate blood or plasma until at least 30 days after their study participation has ended. * Female participants who are currently pregnant or breastfeeding, or who are planning to become pregnant during the study or within 30 days after the last study drug administration. * Show a positive urine alcohol test at screening. * Have smoked or used tobacco- or nicotine-containing products within 30 days prior to the first dose of study treatment until the end of the study. * Have an allergy to capsaicin or another capsaicinoid. * Have a tattoo, excessive scarring or discoloration, keloid formation, or, at the Investigator s discretion, otherwise unhealthy skin (e.g., eczema, psoriasis, burn, and cut) at a QST site. * Have a significant history of nerve injury or damage at a QST site, at the Investigator s discretion. * Participants who report any stimulus as intolerable at any point during the screening procedures will be excluded from participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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Other studies related to the condition(s) this trial covers.
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