Inhaled IAV vs Inhaled Eucalyptus for the Treatment of Nausea With Acute Migraine

Migraine Clinical Trial

Official title:

Double Blind Randomized Control Trial of Inhaled Isopropyl Alcohol Vapors Versus Inhaled Eucalyptus Scent for the Treatment of Nausea Associated With Acute Migraine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05175521
• Other study ID #: 1718502
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2021
• Est. completion date: December 23, 2024

Study information

• Verified date: October 2023
• Source: HonorHealth Research Institute
• Contact: Angelina Cooper
• Phone: 480-583-3193
• Email: ancooper[@]honorhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to compare the efficacy and adverse events of inhaled isopropyl alcohol vapor (IAV) versus placebo (inhaled eucalyptus scent (IES) (1:20 dilution in mineral oil) for treating nausea associated with acute migraine attacks.

Description:

The main goal of this study is to examine the efficacy of (nausea reduction and time to use of other anti-nausea medications) and side effects of inhaled isopropyl alcohol vapor (IAV) for treating nausea among migraine patients using a double blind randomized control methodology. IAV is being compared inhaled eucalyptus scent (IES) (1:20 dilution in mineral oil) which has not shown benefit for treating nausea or migraine and is therefore considered placebo in this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 23, 2024
• Est. primary completion date: July 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients 18 to 65 years old with nausea associated migraines at least twice per month

Exclusion Criteria:

• Patients <18 or >65 years old

• Patients without a diagnosis of acute migraine

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders
• Nausea

Intervention

Other:
• Eucalyptus Oil Scent
Eucalyptus oil in mineral (1:20) will be inhaled at least 30 minutes after onset of nausea associated with a migraine attack
• Isopropyl Alcohol Vapors
Isopropyl Alcohol 70% will be inhaled at least 30 minutes after onset of nausea associated with a migraine attack

Locations

Country	Name	City	State
United States	HonorHealth Bob Bové Neuroscience Institute	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
HonorHealth Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Severity of Nausea on Nausea Scale	Change in Nausea, modified visual analog score from 0-10 with 10 severe nausea with vomiting, 5 moderate nausea, 1 mild nausea and 0 no nausea.	½ hour or to the end of treatment
Secondary	Side effects associated with interventional substance	Patient written report	½ hour, but likely less than 2 hours
Secondary	Use of anti-nausea medication/Time to use of anti-nausea medication	Did using IAV vs eucalyptus oil change the time until use of oral anti-emetic?	½ hour or to the end of treatment
Secondary	Time to Clinically Relevant Nausea Change	Did IAV vs eucalyptus oil reduce the amount of time the patient experienced nausea with their migraine?	½ hour or to the end of treatment