Human Experimental Models of Pain (HEMP)

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Study ID
NCT07549490
Status
Not Yet Recruiting

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Conditions

  • Acute Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo — DRUG
    Over-encapsulated matching placebo administered as a single oral dose in one treatment period of this randomized, double-blind, 3-period crossover study. The placebo is made to look identical to active study drug capsules to maintain blinding. Each participant receives placebo once, with at least 48 hours washout between treatment periods.
  • Naproxen — DRUG
    Over-encapsulated oral naproxen, 550 mg, administered as a single dose in one treatment period of this randomized, double-blind, 3-period crossover study. Each participant receives naproxen once, with at least 48 hours washout between treatment periods.
  • Pregabalin — DRUG
    Over-encapsulated oral pregabalin, 300 mg, administered as a single dose in one treatment period of this randomized, double-blind, 3-period crossover study. Each participant receives pregabalin once, with at least 48 hours washout between treatment periods.

Study Details

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 Dates

Start date
Jun 16, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Sequence ABC (Pregabalin - Naproxen - Placebo)
    Participants assigned to this sequence will receive single-dose oral pregabalin 300 mg in Period 1, naproxen 550 mg in Period 2, and matching placebo in Period 3. Treatment periods are separated by at least 48 hours.
  • Experimental: Sequence ACB (Pregabalin - Placebo - Naproxen)
    Participants assigned to this sequence will receive single-dose oral pregabalin 300 mg in Period 1, matching placebo in Period 2, and naproxen 550 mg in Period 3. Treatment periods are separated by at least 48 hours.
  • Experimental: Sequence BAC (Naproxen - Pregabalin - Placebo)
    Participants assigned to this sequence will receive single-dose oral naproxen 550 mg in Period 1, pregabalin 300 mg in Period 2, and matching placebo in Period 3. Treatment periods are separated by at least 48 hours.
  • Experimental: Sequence BCA (Naproxen - Placebo - Pregabalin)
    Participants assigned to this sequence will receive single-dose oral naproxen 550 mg in Period 1, matching placebo in Period 2, and pregabalin 300 mg in Period 3. Treatment periods are separated by at least 48 hours.
  • Experimental: Sequence CAB (Placebo - Pregabalin - Naproxen)
    Participants assigned to this sequence will receive matching placebo in Period 1, pregabalin 300 mg in Period 2, and naproxen 550 mg in Period 3. Treatment periods are separated by at least 48 hours.
  • Experimental: Sequence CBA (Placebo - Naproxen - Pregabalin)
    Participants assigned to this sequence will receive matching placebo in Period 1, naproxen 550 mg in Period 2, and pregabalin 300 mg in Period 3. Treatment periods are separated by at least 48 hours.

Primary Outcome Measure

Change from baseline in pain intensity after cold pressor test [ Time Frame: Baseline and approximately 2, 5, and 8 hours after dosing in each treatment period ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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