Pain Biomarker Study

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

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

Sponsors & Collaborators

• University of California, San Francisco

  collaborator OTHER

• The University of Texas Health Science Center, Houston

  lead OTHER

Principal Investigators

• Mark Burish, MD PhD · The University of Texas Health Science Center, Houston

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-03-21

Primary Completion

2028-05-31

Completion

2028-05-31

FDA Drug

Yes

Countries

• United States

Study Locations