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

50 Participants Needed

Trial Summary

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.

What data supports the effectiveness of inhaled treatments for migraine-related nausea?

Inhaled treatments for migraines, like MAP0004 (an inhaled drug), have shown promising results in reducing migraine symptoms, including nausea, due to their rapid absorption and effectiveness compared to other methods. This suggests that inhaled therapies, such as eucalyptus oil scent or isopropyl alcohol vapors, might also be effective for migraine-related nausea. ^{1 2 3 4 5}

Is inhaled isopropyl alcohol safe for humans?

Research on alcohol-based hand sanitizers, which contain similar alcohols, shows they are generally safe for use in healthcare settings, with no significant risk of developmental or reproductive harm from repeated exposure. ^{6 7 8 9 10}

How does inhaled isopropyl alcohol differ from other treatments for migraine-related nausea?

Inhaled isopropyl alcohol is unique because it uses vapors to potentially relieve nausea associated with migraines, offering a non-oral, fast-acting option compared to traditional oral medications. This method of inhalation is different from other treatments like oral or nasal medications, which may take longer to act or have different side effects. ^{1 11 12 13 14}

What is the purpose of this trial?

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.

Research Team

Jill Rau, MD, PhD

Principal Investigator

HonorHealth Research Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The discovery and development of inhaled therapeutics for migraine. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Sumatriptan nasal spray in adolescent migraineurs: a randomized, double-blind, placebo-controlled, acute study. [2013]

3. England pubmed.ncbi.nlm.nih.gov

MAP0004, orally inhaled dihydroergotamine for acute treatment of migraine: efficacy of early and late treatments. [2021]

4. Switzerland 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]

5. United States pubmed.ncbi.nlm.nih.gov

Breath powered nasal delivery: a new route to rapid headache relief. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Safety assessment for ethanol-based topical antiseptic use by health care workers: Evaluation of developmental toxicity potential. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Low level hyperbaric antagonism of diazepam's locomotor depressant and anticonvulsant properties in mice. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Aging of whiskey increases the potentiation of GABA(A) receptor response. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Antagonism of inhalant and volatile anesthetic enhancement of glycine receptor function. [2021]

11. England pubmed.ncbi.nlm.nih.gov

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

12. England pubmed.ncbi.nlm.nih.gov

Trans-nasal high-flow dehumidified air in acute migraine headaches: A randomized controlled trial. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Treatment of acute migraine headache. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

New Nasal Spray for Migraine Headaches. [2023]