NCT03511846

Pain Biomarker Study

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

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 371 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Migraine
• Cluster Headache
• Trigeminal Autonomic Cephalgia
• Hemicrania Continua
• Paroxysmal Hemicrania
• SUNCT
• Short-Lasting Unilateral Neuralgiform Headache With Conjunctival Injection and Tearing

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-03-21
• Primary completion: 2028-05-31
• Completion: 2028-05-31
• First posted: 2018-04-30
• Last updated: 2026-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study