Pain Medicine Pilot Study, 25 Adults, Apr 24
Summary
This pilot study will test an innovative way to establish how pain medicines provide analgesia in healthy adults. The study (NCT07549490) plans to enroll up to 25 healthy adults in a double-blind, randomized, three-way crossover design, testing pregabalin and naproxen against placebo using experimental pain models including heat/capsaicin skin tests, UVB light tests, and cold pressor tests. This registry entry creates no compliance obligations — it is an informational record of an ongoing clinical investigation.
“This pilot study will test an innovative way to establish how pain medicines provide analgesia in healthy adults.”
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What changed
This document registers a new NIH-sponsored pilot study (NCT07549490) titled Human Experimental Models of Pain (HEMP), which will evaluate pregabalin and naproxen against placebo in up to 25 healthy adults using experimental pain tests including heat/capsaicin skin tests, UVB light tests, and cold pressor tests. The three-way crossover design will administer all three treatments to each participant in randomized order under double-blind conditions. Clinical investigators and pharmaceutical companies should note this registry entry for awareness, though it creates no new compliance obligations. The study represents early-stage clinical research and does not alter any existing regulatory requirements.
Archived snapshot
Apr 25, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Human Experimental Models of Pain (HEMP)
N/A NCT07549490 Kind: NA Apr 24, 2026
Abstract
This pilot study will test an innovative way to establish how pain medicines provide analgesia in healthy adults. The study uses a group of short, controlled pain tests to look at different types of pain responses in the body. The main goal is to find out if this testing approach can show the pain-relieving effects of 2 medicines, pregabalin and naproxen versus placebo, and show how they provide relief of different types of pain.
The study hypothesis is that this pain testing approach administered as a battery would be able to tell the difference between a medicine that works mainly in the brain and spinal cord (pregabalin) and a medicine that works mainly on inflammation in body tissues (naproxen).
Up to 25 healthy adults will take part. Each participant will receive all 3 study treatments, pregabalin, naproxen, and placebo, administered in random order during separate study periods. The order will be assigned by chance. Neither the participant nor the study team will know which treatment is given at each visit.
The study includes several experimental pain tests. These include:
a heat and capsaicin skin test that causes short-term skin sensitivity,
a UVB light test that causes a temporary sunburn-like sensitivity, and
a cold pressor test, in which a hand is placed in very cold water for a short time.
Participants will also have sensory testing to measure how they feel touch, pressure, pinprick, warmth, heat, and cold. Blood samples will be collected to measure stud...
Conditions: Acute Pain
Interventions: Placebo, Naproxen, Pregabalin
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