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Capsaicin + Oxygen + Cold Stimuli for Headache (PBS Trial)
Phase 1
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 minutes before pain stimulation and 10 minutes, 20 minutes, 30 minutes, 60 minutes, and 90 minutes after pain stimulation
Awards & highlights
PBS Trial 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.Check my eligibility
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.See study design
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.
PBS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a type of primary headache, such as migraine or tension headache.
Select...
I am 18 years old or older.
PBS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 minutes before pain stimulation and 10 minutes, 20 minutes, 30 minutes, 60 minutes, and 90 minutes after pain stimulation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 minutes before pain stimulation and 10 minutes, 20 minutes, 30 minutes, 60 minutes, and 90 minutes after pain stimulation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Activation of trigeminoautonomic reflex as assessed by change in Calcitonin gene-related peptide (CGRP) levels from before stimulation to after stimulation.
Activation of trigeminoautonomic reflex as assessed by tear fluid production
Secondary outcome measures
Activation of trigeminoautonomic reflex as assessed by change in pituitary adenylate cyclase activating polypeptide-38 (PACAP-38) levels levels from before stimulation to after stimulation.
Reflex action
Activation of trigeminoautonomic reflex as assessed by nasal fluid production
+2 moreSide effects data
From 2016 Phase 4 trial • 120 Patients • NCT0312440765%
Application site pain
18%
Application site pruritus
3%
Application site erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
QD-Active
QD-Vehicle
BID-Active
BID-Vehicle
PBS 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
903 Previous Clinical Trials
320,606 Total Patients Enrolled
University of California, San FranciscoOTHER
2,503 Previous Clinical Trials
15,236,284 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You smoke or use tobacco or nicotine every day.You are allergic to capsaicin or hot peppers.I need extra oxygen due to a lung or other illness.I have been diagnosed with a type of primary headache, such as migraine or tension headache.I am 18 years old or older.I have a history of heart or brain blood vessel diseases.I have had brain tumors or epilepsy.You have a serious illness or condition that makes it difficult to diagnose headaches or spine pain.I have been diagnosed with lumbar radiculopathy by a pain specialist.I have had injuries, fractures, or birth defects in the roof of my mouth.The individual is able to provide authorization to share their prior medical records and imaging with healthcare providers.
Research Study Groups:
This trial has the following groups:- Group 1: Oral capsaicin
- Group 2: Oral capsaicin and High Flow Oxygen
- Group 3: Topical capsaicin and Medical Air
- Group 4: Topical capsaicin and High Flow Oxygen
- Group 5: Intranasal capsaicin
- Group 6: Intranasal capsaicin and Medical Air
- Group 7: Intranasal capsaicin and Low Flow Oxygen
- Group 8: Cold water irrigation and Medical Air
- Group 9: Topical capsaicin and Low Flow Oxygen
- Group 10: Oral capsaicin and Medical Air
- Group 11: Oral Capsaicin and Low Flow Oxygen
- Group 12: Topical capsaicin
- Group 13: Intranasal capsaicin and High Flow Oxygen
- Group 14: Cold water irrigation
- Group 15: Cold water irrigation and Low Flow Oxygen
- Group 16: Cold water irrigation and High Flow Oxygen
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Migraine Patient Testimony for trial: Trial Name: NCT03511846 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigation still recruiting participants?
"According to clinicaltrials.gov, recruitment for this trial has been concluded since October 31st 2022; however, there are still 231 other trials actively searching for participants. This study was first posted on March 21st 2018 and had not been updated since its closure date."
Answered by AI
What applications does topical capsaicin have in medicine?
"Topical capsaicin is a successful remedy for managing collagous diseases, acute nonspecific tenosynovitis, and musculoskeletal pain."
Answered by AI
Are there potential risks associated with using topical capsaicin therapeutically?
"Due to its Phase 1 trial status, the safety and efficacy of topical capsaicin is still largely unknown. Our team at Power has tentatively given it a score of 1 on our scale from 1 to 3."
Answered by AI
What is the numerical cap for participants enrolled in this research project?
"The recruitment window for this trial has since closed. The initial post was published on March 21st 2018 and the last edit occurred October 31st 2022. For those still searching, 221 clinical studies are presently recruiting individuals with headache symptoms, while 10 trials relating to topical capsaicin actively seek applicants."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Don't know what else to do I've tried everything.
PatientReceived 2+ prior treatments
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