NCT05175521

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

November 11, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 3, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

4.1 years

First QC Date

August 19, 2021

Last Update Submit

April 16, 2026

Conditions

Migraine

Keywords

NauseaIsopropyl alcoholEucalyptusAromatherapyVapors

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Side effects associated with interventional substance

    ½ hour, but likely less than 2 hours

  • Use of anti-nausea medication/Time to use of anti-nausea medication

    ½ hour or to the end of treatment

  • Time to Clinically Relevant Nausea Change

    ½ hour or to the end of treatment

Study Arms (2)

Eucalyptus Oil Scent

PLACEBO COMPARATOR

Eucalyptus oil diluted in mineral oil 1:20

Other: Eucalyptus Oil Scent

Isopropyl Alcohol Vapors

ACTIVE COMPARATOR

Isopropyl Alcohol 70%

Other: Isopropyl Alcohol Vapors

Interventions

Eucalyptus Oil ScentOTHER

Eucalyptus oil in mineral (1:20) will be inhaled at least 30 minutes after onset of nausea associated with a migraine attack

Eucalyptus Oil Scent
Isopropyl Alcohol VaporsOTHER

Isopropyl Alcohol 70% will be inhaled at least 30 minutes after onset of nausea associated with a migraine attack

Isopropyl Alcohol Vapors

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients \<18 or \>65 years old
  • Patients without a diagnosis of acute migraine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HonorHealth Bob Bové Neuroscience Institute

Scottsdale, Arizona, 85251, United States

Location

MeSH Terms

Conditions

Migraine DisordersNausea

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Jill Rau, MD, PhD

    HonorHealth Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2021

First Posted

January 3, 2022

Study Start

November 11, 2021

Primary Completion

December 31, 2025

Study Completion

April 1, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Locations

US(1)