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Capsaicin + Oxygen + Cold Stimuli for Headache (PBS Trial)

Phase 1
Recruiting
Led By Mark Burish, MD PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of a primary headache disorder according to the International Headache Classification, including various types of migraines, tension headache, cluster headache, and other specified types
Age 18 and older
Must not have
Pulmonary or other non-headache diseases that require the use of supplemental oxygen (for oxygen portion of the study)
Known history of cardiovascular or neurovascular diseases including specific conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 minutes after pain stimulation
Awards & highlights
All Individual Drugs Already Approved

Summary

This trial investigates potential physical and molecular biomarkers for headaches, in order to improve our understanding of how these diseases work. Three different stimuli will be used - capsaicin, oxygen gas, and ice water - to see how they affect headache patients compared to controls.

Who is the study for?
This trial is for adults who have been diagnosed with various headache disorders, including migraines and cluster headaches. They must be able to share medical records and not have a history of serious cardiovascular or neurovascular diseases, brain tumors, epilepsy, or be pregnant. Smokers and those with a life expectancy less than 1 year are excluded.
What is being tested?
The study tests if capsaicin (from chili peppers) affects biomarkers in headache sufferers differently from controls when applied as cream, ingested, or used intranasally. It also examines if oxygen gas can reduce eye watering triggered by capsaicin and if ice water can simulate headaches to understand underlying mechanisms.
What are the potential side effects?
Potential side effects may include temporary discomfort at the application site for topical capsaicin; nasal irritation for intranasal use; digestive discomfort from oral ingestion; cold sensitivity during cold water irrigation; and possible breathing difficulties with high flow oxygen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a type of primary headache, such as migraine or tension headache.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need extra oxygen due to a lung or other illness.
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I have a history of heart or brain blood vessel diseases.
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I have had brain tumors or epilepsy.
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I have had injuries, fractures, or birth defects in the roof of my mouth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 minutes after pain stimulation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 minutes after pain stimulation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Activation of trigeminoautonomic reflex as assessed by tear fluid production

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

16Treatment groups
Experimental Treatment
Placebo Group
Group I: Topical capsaicin and Low Flow OxygenExperimental Treatment2 Interventions
Group II: Topical capsaicin and High Flow OxygenExperimental Treatment2 Interventions
Group III: Topical capsaicinExperimental Treatment1 Intervention
Group IV: Oral capsaicin and High Flow OxygenExperimental Treatment2 Interventions
Group V: Oral capsaicinExperimental Treatment1 Intervention
Group VI: Oral Capsaicin and Low Flow OxygenExperimental Treatment2 Interventions
Group VII: Intranasal capsaicin and Low Flow OxygenExperimental Treatment2 Interventions
Group VIII: Intranasal capsaicin and High Flow OxygenExperimental Treatment2 Interventions
Group IX: Intranasal capsaicinExperimental Treatment1 Intervention
Group X: Cold water irrigation and Low Flow OxygenExperimental Treatment2 Interventions
Group XI: Cold water irrigation and High Flow OxygenExperimental Treatment2 Interventions
Group XII: Cold water irrigationExperimental Treatment1 Intervention
Group XIII: Topical capsaicin and Medical AirPlacebo Group2 Interventions
Group XIV: Intranasal capsaicin and Medical AirPlacebo Group2 Interventions
Group XV: Cold water irrigation and Medical AirPlacebo Group2 Interventions
Group XVI: Oral capsaicin and Medical AirPlacebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low Flow Oxygen
2011
N/A
~80

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
949 Previous Clinical Trials
344,654 Total Patients Enrolled
University of California, San FranciscoOTHER
2,587 Previous Clinical Trials
14,900,805 Total Patients Enrolled
7 Trials studying Migraine
672 Patients Enrolled for Migraine
Mark Burish, MD PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
31 Total Patients Enrolled

Media Library

Topical capsaicin Clinical Trial Eligibility Overview. Trial Name: NCT03511846 — Phase 1
Migraine Research Study Groups: Oral capsaicin, Oral capsaicin and High Flow Oxygen, Topical capsaicin and Medical Air, Topical capsaicin and High Flow Oxygen, Intranasal capsaicin, Intranasal capsaicin and Medical Air, Intranasal capsaicin and Low Flow Oxygen, Cold water irrigation and Medical Air, Topical capsaicin and Low Flow Oxygen, Oral capsaicin and Medical Air, Oral Capsaicin and Low Flow Oxygen, Topical capsaicin, Intranasal capsaicin and High Flow Oxygen, Cold water irrigation, Cold water irrigation and Low Flow Oxygen, Cold water irrigation and High Flow Oxygen
Migraine Clinical Trial 2023: Topical capsaicin Highlights & Side Effects. Trial Name: NCT03511846 — Phase 1
Topical capsaicin 2023 Treatment Timeline for Medical Study. Trial Name: NCT03511846 — Phase 1
Migraine Patient Testimony for trial: Trial Name: NCT03511846 — Phase 1
~68 spots leftby May 2026
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