Human Experimental Models of Pain (HEMP)

Starting soon · Not applicable · Has a placebo group

Conditions studied: Acute Pain

In brief

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 study drug levels. Urine samples, vital signs, and other safety checks will also be done. Each treatment visit includes testing before and for several hours after taking the study drug. There will be a washout period of at least 48 hours between treatments. Total participation may last up to about 10 weeks. This study is not expected to provide direct medical benefit to participants. The information learned may help researchers improve early testing of future pain treatments....

Key facts

Study ID

NCT07549490

Run by

National Center for Complementary and Integrative Health (NCCIH)

People needed

25

Starts

2026-08-13

Expected to finish

2030-12-31

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.