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Human Experimental Models of Pain (HEMP)

A Pilot Study for Developing a Comprehensive Signal Detection Approach for the Mechanisms of Action and Analgesic Efficacy of Two Analgesics Using Human Experimental Models of Pain (HEMP)

Sponsor
National Center for Complementary and Integrative Health (NCCIH) (NIH)
Enrollment
25 planned
Conditions
Acute Pain
Interventions
Placebo; Naproxen; Pregabalin
Ages
adults, older adults
Registry
NCT07549490

Full record on ClinicalTrials.gov

From the registry

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:…

Primary outcomes

  • Change from baseline in pain intensity after cold pressor test
  • Change from baseline in pain intensity for allodynia (soft brush) after first heat/capsaicin pain model application
  • Change from baseline in pain intensity for hyperalgesia (pin-prick) after first heat/capsaicin pain model application
  • Change from baseline in pain intensity for mechanical hyperalgesia (pin-prick) at the UVB site

History

  1. Study completion expected

  2. Primary completion expected

  3. Expected to start

  4. Last registry update

  5. Registered