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ENROLLING BY INVITATION
NCT03511846
PHASE1

Pain Biomarker Study

Sponsor: The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

Summary

This study investigates molecular and physical biomarkers of headaches in order to better understand mechanisms of these diseases. There are 3 main parts: 1. Use of capsaicin (active ingredient in hot chili peppers) to trigger release of calcitonin gene related peptide - the hypothesis is that this will be different in headache subjects compared to controls (and if so might be used to predict how these patients will respond to certain medications that modulate calcitonin gene-related peptide). Subjects will be given capsaicin as a cream applied to the forehead or the inner nostril, or a hot sauce that is ingested. 2. Use of capsaicin to trigger eye watering - the hypothesis is that oxygen gas will slow down the amount of eye watering. Cluster headache patients respond very powerfully to oxygen gas but to very little else. The mechanism for oxygen is unknown but in rodents there is data that it works on the parasympathetic / lacrimal gland system. This study translates rodent data into humans in a non-invasive way to confirm the mechanism of this very effective treatment. 3. Use of ice water to trigger headaches - brain freeze causes a very short-lived but intense headache that may cause similar biomarker release as other headache disorders. This may be a useful human model for other headache disorders.

Official title: The Pain Biomarker Study: Changes in Circulating Pain Signalling Molecules With Activation of Pain Receptors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

371

Start Date

2018-03-21

Completion Date

2028-05-31

Last Updated

2026-02-18

Healthy Volunteers

Yes

Interventions

DRUG

Oral capsaicin

Subjects will drink a solution with capsaicin

DRUG

Topical capsaicin

Capsaicin cream will be applied to the skin of the forehead, cheek, or leg

DRUG

Intranasal capsaicin

Capsaicin cream will be applied to the nostril

OTHER

Cold Water Irrigation

Subjects will be asked to drink up to 2000 ml of cold water or ice water (temperature 0-10 degrees Celsius) as fast as possible, either continuously or intermittently (i.e. 200-800 ml at a time)

OTHER

Medical Air

Subjects will be exposed to medical air

DRUG

Low Flow Oxygen

Subjects will be exposed to oxygen gas between 1-9 L/min

DRUG

High Flow Oxygen

Subjects will be exposed to oxygen gas between 10-25 L/min

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States