Nebulized Scopolamine for Motion Sickness

Overseen By Shireen Geimer, MS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Dartmouth-Hitchcock Medical Center

Must not be taking: Intranasal medications

Disqualifiers: Drug allergies, Tobacco, Gastrointestinal disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the delivery of anti-motion sickness medicine using a nasal spray device. Researchers are testing Scopolamine, a medication that prevents nausea and dizziness during motion sickness. Participants will receive varying doses of Scopolamine or a placebo (a harmless substance with no medical effect) through a nasal spray. Individuals who frequently experience motion sickness and are in good health may be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications at least one week before starting the study.

What prior data suggests that this method is safe for administering anti-motion sickness medications?

Research has shown that scopolamine often prevents nausea and vomiting from motion sickness and is usually well-tolerated in forms like patches. However, some safety concerns exist. One study found that scopolamine can raise body temperature, especially in hot weather.

Additionally, a review of several studies confirmed that scopolamine is effective for motion sickness, but like any medication, it can cause side effects. Some people might experience dry mouth or dizziness. Importantly, the current trial tests scopolamine using a nasal spray. This method is still under study, so information on its safety is limited. As a Phase 1 trial, the main goal is to assess the safety of this new delivery method for people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about nebulized scopolamine for motion sickness because it offers a new delivery method for an existing medication. Most treatments for motion sickness, like oral scopolamine pills or transdermal patches, can take longer to act or may cause drowsiness. This investigational treatment uses an intranasal nebulizer, developed by Creare LLC, which could enable faster absorption and quicker relief. With potential doses of 0.2 mg and 0.4 mg, its rapid delivery might provide an effective and convenient alternative to current options.

What evidence suggests that nebulized scopolamine is effective for motion sickness?

Research shows that scopolamine reduces motion sickness symptoms. Studies have found that scopolamine patches, worn on the skin, can lower motion sickness by 60-80%. In this trial, participants will receive scopolamine delivered through the nose, known as intranasal scopolamine, which also shows promise in preventing motion sickness. Early results suggest that this method might work faster and more directly. Overall, scopolamine outperforms a placebo in preventing nausea and vomiting caused by motion sickness. ^{3 6 7 8 9}

Who Is on the Research Team?

Jay Buckey, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

Adults aged 21-49 in good health, with normal weight and organ function, can join this trial. They must not have used investigational drugs recently, smoked tobacco within a year, or lost significant blood lately. Pregnant women and those on certain medications or with specific medical conditions like respiratory issues or drug allergies are excluded.

Inclusion Criteria

, is required for all study participants The study participants need to be in good health, as determined by their verbal medical history.

My weight is normal for my height.

My kidney and liver functions are normal.

Exclusion Criteria

I am allergic to scopolamine or similar medications.

I have a significant condition like Crohn's, asthma, or glaucoma.

Consumption of grapefruit juice within 7 days of scopolamine (SCOP) administration

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive doses of Scopolamine and placebo via intranasal nebulizer, with each dose administered 1 week apart

3 weeks

3 visits (in-person)

Pharmacokinetic Assessment

Pharmacokinetics of scopolamine are measured using LC-MS assay

180 minutes

1 visit (in-person)

Follow-up

Participants are monitored for side effects and effectiveness in reducing motion sickness

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Scopolamine

Trial Overview

The study is testing the effectiveness of delivering Scopolamine through an intranasal nebulizer to prevent motion sickness compared to a placebo (a treatment with no active drug). Participants will receive either the real medication or placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: Pharmacokinetic Experimental Treatment 1 Intervention

Participants receive 1 dose of Scopolamine 0.4 mg delivered via a intranasal nebulizer developed by Creare LLC.

Group II: Chair Experimental Treatment 2 Interventions

Participants receive 1 dose of Scopolamine 0.2 mg, 1 dose of Scopolamine 0.4 mg, and 1 dose of placebo saline delivered via the Creare LLC intranasal nebulizer. These dosages are all 1 week apart and the order is randomized.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Published Research Related to This Trial

A new formulation of scopolamine nasal spray was found to be effective in treating motion sickness, significantly reducing seasickness scores compared to placebo and dimenhydrinate in a study involving a randomized, double-blind, crossover design.

The nasal spray demonstrated a fast onset of action within 30 minutes and showed no signs of nasal or epipharyngeal irritation, indicating it is a safe and well-tolerated option for motion sickness treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scopolamine nasal spray in motion sickness: a randomised, controlled, and crossover study for the comparison of two scopolamine nasal sprays with oral dimenhydrinate and placebo. Klöcker, N., Hanschke, W., Toussaint, S., et al.[2019]

In a study involving eight male students, transdermal scopolamine was found to be effective in reducing motion sickness symptoms, with a 63% efficacy rate, while oral scopolamine had a detrimental effect.

Promethazine combined with ephedrine was the most effective treatment, showing an 86% efficacy, suggesting that while scopolamine is beneficial, other combinations may offer superior results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of experimental motion sickness by scopolamine absorbed through the skin. Graybiel, A., Knepton, J., Shaw, J.[2018]

Transdermal scopolamine (Transderm-Scop) is effective for preventing motion sickness and has a lower risk of central nervous system (CNS) side effects compared to oral scopolamine, making it a safer option for many users.

However, CNS side effects can still occur, particularly in elderly patients or those with certain preexisting conditions, and diagnosing these side effects can be challenging due to the patch's location and delayed symptom onset.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdermal scopolamine-induced psychosis. Ziskind, AA.[2019]

Intranasal scopolamine (INSCOP) significantly improved tolerance to motion sickness in 16 susceptible subjects, allowing them to endure more head movements compared to a placebo, indicating its efficacy as a treatment.

The intranasal formulation was absorbed rapidly, reaching measurable plasma levels within 15 minutes, and did not cause significant cognitive or sedative side effects, making it a safe alternative for motion sickness prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of low-dose intranasal scopolamine for motion sickness. Simmons, RG., Phillips, JB., Lojewski, RA., et al.[2019]

Transdermal scopolamine was tested against oral medications for preventing space motion sickness in a double-blind study, focusing on its early phase actions and efficacy during standardized head movements.

The study documented various physiological and psychological responses to assess the effectiveness of transdermal scopolamine compared to oral promethazine and ephedrine, highlighting its potential as a viable option for astronauts experiencing motion sickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative efficacy of the proposed Space Shuttle antimotion sickness medications. Hordinsky, JR., Schwartz, E., Beier, J., et al.[2019]

Intranasal scopolamine gel (INSCOP) was tested in a study with 12 healthy subjects and showed dose-linear pharmacokinetics, meaning that higher doses led to proportionally higher drug levels in the blood.

All doses of INSCOP were well tolerated with no serious side effects, indicating that it is a fast, reliable, and safe alternative for treating space motion sickness compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose escalation pharmacokinetics of intranasal scopolamine gel formulation. Wu, L., Boyd, JL., Daniels, V., et al.[2018]

The novel in situ gel formulation of scopolamine hydrobromide (SCOP) for nasal delivery was found to be safe, showing no nasal ciliotoxicity, and demonstrated prolonged residence time in the nasal cavity compared to traditional methods.

In a study involving rats, the intranasal SCOP gel significantly reduced motion sickness symptoms more effectively than subcutaneous and oral administration, indicating its potential as a superior treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation of ion-activated in situ gel systems of scopolamine hydrobromide and evaluation of its antimotion sickness efficacy. Cao, SL., Zhang, QZ., Jiang, XG.[2022]

Transdermal scopolamine significantly reduces motion-induced nausea, achieving a motion sickness incidence of only 16% in a study of 35 susceptible subjects, compared to 32% with oral dimenhydrinate and 59% with placebo.

The transdermal system provides sustained relief for up to 72 hours, offering advantages over oral or intramuscular administration, especially during gastrointestinal distress, and resulting in a 73% protection rate against motion sickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of transdermally administered scopolamine in preventing motion sickness. McCauley, ME., Royal, JW., Shaw, JE., et al.[2018]

In a study involving 46 young male marines, TTS-scopolamine significantly reduced motion sickness symptoms by 89%, compared to a 59% reduction with meclozine tablets, indicating its superior efficacy.

TTS-scopolamine offers the advantage of consistent blood levels over three days and avoids gastrointestinal side effects, making it a potentially more effective option for preventing motion sickness than traditional oral medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prevention of motion sickness with a transdermal therapeutic system containing scopolamine. A randomized, comparative double-blind study in the German Federal Navy]. Becker, G., Goossens, H., Seemann, K., et al.[2018]

Citations

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Nebulized Scopolamine for Motion Sickness

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Scopolamine is known to be an effective motion sickness deterrent, but these noteworthy findings for low dose, intranasally delivered scopolamine hold ...

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FDA is warning that the antinausea patch Transderm Scōp (scopolamine transdermal system) can lead to an increase in body temperature, resulting ...

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