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Human Experimental Models of Pain (HEMP)

ConditionAcute Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNational Center for Complementary and Integrative Health (NCCIH)

About this trial

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....

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

25 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Sequence ABC (Pregabalin - Naproxen - Placebo)Experimental treatment 3 interventions
Group B: Sequence ACB (Pregabalin - Placebo - Naproxen)Experimental treatment 3 interventions
Group C: Sequence BAC (Naproxen - Pregabalin - Placebo)Experimental treatment 3 interventions
Group D: Sequence BCA (Naproxen - Placebo - Pregabalin)Experimental treatment 3 interventions
Group E: Sequence CAB (Placebo - Pregabalin - Naproxen)Experimental treatment 3 interventions
Group F: Sequence CBA (Placebo - Naproxen - Pregabalin)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Change from baseline in pain intensity after cold pressor test

Change from baseline in participant-rated pain intensity VAS score measured immediately after hand removal from cold water during the cold pressor test (CPT). Higher scores indicate greater pain intensity.

Time frame
Baseline and approximately 2, 5, and 8 hours after dosing in each treatment period
2

Change from baseline in pain intensity for allodynia (soft brush) after first heat/capsaicin pain model application

Change from baseline in participant-rated pain intensity VAS score for soft-brush allodynia at the heat/capsaicin pain model (HCM) site after the first HCM application. Higher scores indicate greater pain intensity.

Time frame
Baseline and approximately 2, 5, and 8 hours after dosing in each treatment period
3

Change from baseline in pain intensity for hyperalgesia (pin-prick) after first heat/capsaicin pain model application

Change from baseline in participant-rated pain intensity VAS score for pin-prick hyperalgesia at the HCM site after the first HCM application. Higher scores indicate greater pain intensity.

Time frame
Baseline and approximately 2, 5, and 8 hours after dosing in each treatment period
4

Change from baseline in pain intensity for mechanical hyperalgesia (pin-prick) at the UVB site

Change from baseline in participant-rated pain intensity VAS score for pin-prick hyperalgesia at the UVB-treated skin site. Higher scores indicate greater pain intensity.

Time frame
Baseline and approximately 2, 5, and 8 hours after dosing in each treatment period

Secondary outcomes

1

Weighted mean pain intensity VAS score for spontaneous pain over 0 to 60 minutes following first and second HCM applications

Weighted mean spontaneous pain visual analog scale (VAS) score calculated using area under the curve (AUC) over 60 minutes after each HCM application. Higher scores indicate greater spontaneous pain.

Time frame
0 to 60 minutes after the first and second HCM applications during each treatment period
2

Area of secondary hyperalgesia to pin-prick following first and second HCM applications

Size of the mapped area of secondary pin-prick hyperalgesia at the HCM site after each HCM application. Larger area indicates greater secondary hyperalgesia.

Time frame
After the first and second HCM applications during each treatment period
3

Change from baseline in pain intensity VAS score for thermal-heat hyperalgesia following first and second HCM applications

Change from baseline in participant-rated pain intensity VAS score for thermal-heat pain hyperalgesia at the HCM site after first and second HCM applications. Higher scores indicate greater pain intensity.

Time frame
Baseline and approximately 2, 5, and 8 hours after dosing in each treatment period
4

Proportion of participants with at least 30% reduction from baseline in pain intensity VAS score after QST measures at HCM and UVB sites

Proportion of participants with at least 30% reduction from baseline in pain intensity VAS score after quantitative sensory testing (QST) modalities, including soft brush, light pressure, pin-prick, warm, heat pain, and cold, at HCM and UVB sites.

Time frame
Baseline and approximately 2, 5, and 8 hours after dosing in each treatment period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Center for Complementary and Integrative Health (NCCIH)

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: