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

Not Applicable

Recruiting

• Conditions: Migraine

• Registration Number: NCT05175521
• Lead Sponsor: HonorHealth Research Institute

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-08-19
• Study Start: 2021-11-11
• Study First Submitted QC: 2021-12-27
• Study First Posted: 2022-01-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-01-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of Severity of Nausea on Nausea Scale	½ hour or to the end of treatment	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.

Secondary Outcome Measures

Name	Time	Method
Time to Clinically Relevant Nausea Change	½ hour or to the end of treatment	Did IAV vs eucalyptus oil reduce the amount of time the patient experienced nausea with their migraine?
Side effects associated with interventional substance	½ hour, but likely less than 2 hours	Patient written report
Use of anti-nausea medication/Time to use of anti-nausea medication	½ hour or to the end of treatment	Did using IAV vs eucalyptus oil change the time until use of oral anti-emetic?

Trial Locations

Locations (1)

HonorHealth Bob Bové Neuroscience Institute; 🇺🇸 Scottsdale, Arizona, United States