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Pain Biomarker Study
Sponsor: The University of Texas Health Science Center, Houston
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
Conditions
Interventions
Oral capsaicin
Subjects will drink a solution with capsaicin
Topical capsaicin
Capsaicin cream will be applied to the skin of the forehead, cheek, or leg
Intranasal capsaicin
Capsaicin cream will be applied to the nostril
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)
Medical Air
Subjects will be exposed to medical air
Low Flow Oxygen
Subjects will be exposed to oxygen gas between 1-9 L/min
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