Inhaled Isopropyl Alcohol vs Eucalyptus for Migraine-Related Nausea

Overseen By Angelina Cooper

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HonorHealth Research Institute

Disqualifiers: Age, No migraine diagnosis

Compensation: Varies

Number of Visits: Unknown

Duration: ½ hour to 2 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the effectiveness of inhaling isopropyl alcohol vapor compared to eucalyptus scent for easing nausea during migraine attacks. The researchers seek to identify which option better alleviates nausea and what side effects might arise. Individuals who experience nausea with migraines at least twice a month may be suitable candidates for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance nausea relief options for migraine sufferers.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that inhaling isopropyl alcohol vapors can cause side effects, such as headaches, dizziness, drowsiness, or nausea. Inhaling large amounts may lead to more serious issues like fainting or neurological problems.

Isopropyl alcohol is highly flammable, but clinical trials typically implement safety measures to minimize risks.

Using isopropyl alcohol in medical settings is common, yet understanding these risks can assist in deciding whether to join a trial. Discuss any concerns with the study team or your doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for migraine-related nausea, which often include oral medications like antiemetics, inhaled isopropyl alcohol offers a unique, non-oral delivery method. This can be particularly beneficial for patients who struggle with swallowing pills during a migraine attack. Additionally, isopropyl alcohol vapors work through inhalation, potentially providing rapid relief by quickly reaching the bloodstream through the lungs. Researchers are excited about this approach because it may offer a faster onset of action compared to traditional oral medications.

What evidence suggests that this trial's treatments could be effective for migraine-related nausea?

This trial will compare the effectiveness of inhaled isopropyl alcohol vapors with eucalyptus oil scent for migraine-related nausea. Research has shown that inhaling isopropyl alcohol (IPA) effectively reduces nausea. In one study, participants' nausea scores dropped from 50 to 20 out of 100 with IPA, compared to a drop to 40 with a common anti-nausea drug. Another study found that IPA worked faster than usual medications to provide 50% relief from nausea. Additionally, IPA significantly reduced nausea in patients with mild head injuries within 30 minutes. These findings suggest that inhaling isopropyl alcohol can quickly ease nausea symptoms. ^{6 7 8 9 10}

Who Is on the Research Team?

Jill Rau, MD, PhD

Principal Investigator

HonorHealth Research Institute

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 65 who experience nausea with their migraines at least twice a month. It's not suitable for those under 18 or over 65, or patients without an acute migraine diagnosis.

Exclusion Criteria

I have not been diagnosed with acute migraines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive inhaled isopropyl alcohol vapor or inhaled eucalyptus scent for treating nausea associated with acute migraine

½ hour to 2 hours

Follow-up

Participants are monitored for side effects and changes in nausea severity after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Eucalyptus Oil Scent
• Isopropyl Alcohol Vapors

Trial Overview The study aims to see if inhaling isopropyl alcohol vapors (IAV) is more effective and safer than a placebo, which in this case is diluted eucalyptus oil scent (IES), for relieving nausea during acute migraine attacks.

How Is the Trial Designed?

Group I: Isopropyl Alcohol Vapors Active Control 1 Intervention

Isopropyl Alcohol 70%

Group II: Eucalyptus Oil Scent Placebo Group 1 Intervention

Eucalyptus oil diluted in mineral oil 1:20

Who Is Running the Clinical Trial?

HonorHealth Research Institute

Lead Sponsor

Trials

26

Recruited

940+

Published Research Related to This Trial

A study assessing the safety of alcohol-based hand sanitizers (ABHS) in healthcare found that even with intensive use, the resulting internal doses of ethanol are low and comparable to those from consuming non-alcoholic beverages, indicating no significant risk of developmental toxicity.

The research supports that ABHS are safe for regular use in infection control procedures, as the estimated exposure levels are well below the occupational exposure limits set by safety authorities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety assessment for ethanol-based topical antiseptic use by health care workers: Evaluation of developmental toxicity potential. Maier, A., Ovesen, JL., Allen, CL., et al.[2015]

In a study involving two lines of mice (long sleep and short sleep), varying concentrations of ethanol led to a decrease in respiration rate and blood pH, indicating a concentration-dependent effect of ethanol on these physiological parameters.

While blood PCO2 increased only at the highest ethanol concentration, blood PO2 levels were significantly elevated in long sleep mice across all ethanol concentrations, suggesting that different mouse lines respond differently to ethanol's effects on blood oxygen levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential effects of ethanol concentration on blood pH, PCO2 and PO2 in LS and SS mice. Gilliam, DM., Collins, AC.[2019]

Effective first-line treatments for mild to moderate migraines include over-the-counter nonsteroidal anti-inflammatory drugs and combination analgesics, while triptans are recommended for moderate to severe migraines or those not responding to simple analgesics.

In emergency settings, intravenous antiemetics and dihydroergotamine are effective, and dexamethasone may help prevent headache recurrence, but opiates and barbiturates should be avoided for acute migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of acute migraine headache. Gilmore, B., Michael, M.[2022]

Exposure to 12 ATA heliox gas can effectively counteract the depressant effects of diazepam in mice, but only at certain doses, indicating a selective antagonistic effect.

The study suggests that low level hyperbaric exposure acts as a direct antagonist for drugs that modulate receptor function, particularly highlighting its potential mechanism of action against substances like ethanol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low level hyperbaric antagonism of diazepam's locomotor depressant and anticonvulsant properties in mice. Davies, DL., Bejanian, M., Parker, ES., et al.[2013]

Whiskey, along with its minor components, significantly enhances the response of GABA(A) receptors more than ethanol at the same concentration, suggesting a stronger sedative effect.

The effectiveness of whiskey in potentiating GABA(A) receptor activity increases with its aging period, indicating that both ethanol and other compounds in whiskey contribute to its mood-altering effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aging of whiskey increases the potentiation of GABA(A) receptor response. Koda, H., Hossain, SJ., Kiso, Y., et al.[2013]

In a study involving 51 migraine patients, trans-nasal high-flow dry gas therapy (including dry oxygen and dry air) significantly reduced headache pain and photosensitivity compared to humidified air, indicating its potential as an effective treatment for migraines.

No adverse events were reported during the trial, suggesting that this therapy is safe for acute migraine management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trans-nasal high-flow dehumidified air in acute migraine headaches: A randomized controlled trial. Shah, R., Assis, F., Narasimhan, B., et al.[2021]

Research indicates that alcohols and volatile anesthetics may act on overlapping sites of glycine receptors, suggesting a common mechanism of action for these substances.

Ethanol can inhibit the effects of volatile anesthetics like enflurane, toluene, and chloroform on glycine receptors, highlighting the potential for pharmacological antagonism in managing anesthetic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antagonism of inhalant and volatile anesthetic enhancement of glycine receptor function. Beckstead, MJ., Phelan, R., Mihic, SJ.[2021]

Propofol may be a safe and effective treatment for acute migraine in emergency department patients, based on a review of three relevant studies.

However, more rigorous trials are necessary to compare propofol's efficacy against standard migraine therapies before it can be widely recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards evidence-based emergency medicine: best BETs from the Manchester Royal Infirmary. BET 1: Propofol for migraine. Robert, S., Ghanayem, H.[2013]

Inhalation therapy for migraine treatment, particularly with MAP0004 (inhaled dihydroergotamine mesylate), has shown promising efficacy and better tolerability compared to traditional parenteral methods, based on phase 3 studies.

Inhaled prochlorperazine demonstrated good pharmacokinetics and efficacy in phase 2 trials, while inhaled loxapine did not show encouraging results, indicating variability in effectiveness among inhaled migraine treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The discovery and development of inhaled therapeutics for migraine. Vandenbussche, N., Goadsby, PJ.[2020]

Zavegepant (Zavzpret) is an effective nasal spray approved for treating acute migraines in adults, but it is not intended for preventive use.

Common side effects include taste disorders, nausea, nasal discomfort, and vomiting, and it should not be used with intranasal decongestants as they can reduce its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Nasal Spray for Migraine Headaches. Aschenbrenner, DS.[2023]

In a study involving 738 adolescents aged 12 to 17, sumatriptan nasal spray (20 mg) was found to provide significant headache relief compared to placebo at 30 minutes and 2 hours after administration, indicating its potential efficacy for treating acute migraine in this age group.

Both doses of sumatriptan nasal spray (5 mg and 20 mg) were well tolerated, with no serious adverse events reported; however, taste disturbance was more common in those receiving sumatriptan, highlighting a manageable side effect profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sumatriptan nasal spray in adolescent migraineurs: a randomized, double-blind, placebo-controlled, acute study. Winner, P., Rothner, AD., Wooten, JD., et al.[2013]

MAP0004, an inhaled dihydroergotamine, was significantly more effective than placebo in relieving migraine pain at all treatment time points, including up to 8 hours after migraine onset, based on a study of 902 patients.

The treatment also resulted in higher pain-free rates compared to placebo within 8 hours of migraine onset, demonstrating its efficacy as a flexible option for acute migraine management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MAP0004, orally inhaled dihydroergotamine for acute treatment of migraine: efficacy of early and late treatments. Tepper, SJ., Kori, SH., Goadsby, PJ., et al.[2021]

In a study of 74 patients, intranasal sumatriptan (40 mg total) significantly relieved migraine headaches compared to placebo, with 75% of patients experiencing relief at 120 minutes versus only 32% in the placebo group.

Sumatriptan not only reduced headache severity but also decreased nausea, vomiting, and functional disability, suggesting it may eliminate the need for additional anti-nausea medications during migraine attacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A placebo-controlled study of intranasal sumatriptan for the acute treatment of migraine. The Finnish Sumatriptan Group and the Cardiovascular Clinical Research Group. [2018]

Breath Powered bi-directional delivery significantly improves the deposition of sumatriptan in the nasal cavity, leading to better absorption and pharmacokinetics compared to traditional nasal sprays, as shown in multiple studies.

This innovative delivery method not only provides faster pain relief for migraine sufferers but also allows for targeted delivery to areas associated with headache pain, potentially enhancing the effectiveness of headache treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breath powered nasal delivery: a new route to rapid headache relief. Djupesland, PG., Messina, JC., Mahmoud, RA.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6189884/

Inhaled isopropyl alcohol for nausea and vomiting in the ... For example, after 30 minutes the nausea score improved from 50 out of 100 to 20 with inhaled isopropyl alcohol versus 40 with oral ondansetron.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9676696/

Aromatherapy with Isopropyl Alcohol versus Intravenous ... Conclusion: Aromatherapy using isopropyl alcohol significantly reduced nausea of patients with mild isolate head trauma after 30 minutes. Regarding vomiting, no ...

3. aamsn.org aamsn.org/wp-content/uploads/2024/08/IPA_study_to_home.pdf

A Comparative analysis of isopropyl alcohol and ... The results of this study suggest that IPA is much faster than ondansetron for 50% relief of nausea. Key words: Aromatherapy, isopropyl alcohol, ondansetron,.

4. link.springer.com link.springer.com/article/10.1007/s00228-023-03560-x

Isopropyl alcohol inhalation versus 5-HT 3 antagonists for ... Nausea score reduction at 30 min was significantly greater in the IPA group (MD 21.47; 95% CI 15.47, 27.47). IPA led to significantly reduced ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S019606441501361X

Isopropyl Alcohol Nasal Inhalation for Nausea in the ... We found that nasally inhaled isopropyl alcohol achieves increased nausea relief compared with placebo during a 10-minute period.

6. airgas.com airgas.com/msds/001105.pdf

Isopropyl Alcohol Hazard statements. : Highly flammable liquid and vapor. Causes serious ... nausea or vomiting headache drowsiness/fatigue dizziness/vertigo unconsciousness.

7. nrf.aux.eng.ufl.edu nrf.aux.eng.ufl.edu/_files/msds/2/Isopropyl%20Alcohol.pdf

Material Safety Data Sheet Isopropyl Alcohol, 50-100% v/v May cause kidney damage. May cause central nervous system depression, characterized by excitement, followed by headache, dizziness, drowsiness, and nausea.

8. fishersci.com fishersci.com/content/dam/fishersci/en_US/documents/programs/education/regulatory-documents/sds/chemicals/chemicals-i/S25372A.pdf

Safety Data Sheet Hazard statements: Highly flammable liquid and vapour. Causes serious eye irritation. May cause drowsiness or dizziness.

9. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_MGM23_ALCOHOL_ISOPROPYL_91PERCENT_16OZ_12CS.pdf

Safety Data Sheet Isopropyl Alcohol 91% - 1. Identification Signs and Symptoms of Exposure: Giddiness, headache, dizziness and nausea. Health Hazards (Acute and Chronic): Generally used as a rubdown.

10. medline.com medline.com/media/catalog/Docs/MSDS/MSD_SDS0200.pdf

Safety Data Sheet Inhalation: Inhalation of high concentrations may cause central nervous system effects characterized by nausea, headache, dizziness, unconsciousness and coma.