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Nebulized Scopolamine for Motion Sickness

Phase 1
Recruiting
Led By Jay C Buckey, Ph.D
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Renal and hepatic function within normal ranges
Adults age 21-49
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 minutes
Awards & highlights

Study Summary

This trial is testing a nebulizer that goes up the nose to see if it is a better way to give anti-motion sickness medication.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Scopolamine may cause dry mouth, dizziness, blurred vision, and drowsiness. Less common side effects include confusion and difficulty urinating. The placebo is unlikely to cause any side effects since it doesn't contain an active drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney and liver functions are normal.
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I am between 21 and 49 years old.
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My weight is normal for my height.
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My kidney and liver functions are normal.
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I am between 21 and 49 years old.
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My weight is normal for my height.
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I am either male or female.
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I am between 21 and 49 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Side effects of intranasal scopolamine, as measured through a questionnaire with a subjective rating scale
Time to maximal concentration for scopolamine after intranasal administration (Tmax)
Secondary outcome measures
Effectiveness in reducing motion sickness as measured by duration of chair ride.

Side effects data

From 2014 Phase 1 trial • 27 Patients • NCT02051335
12%
Dizziness
8%
Vision blurred
8%
Dry mouth
100%
80%
60%
40%
20%
0%
Study treatment Arm
A: Placebo
C: Roflumilast Dose A
B: Donepezil 10 mg
D: Roflumilast Dose A + Donepezil 10 mg

Trial Design

2Treatment groups
Experimental Treatment
Group I: PharmacokineticExperimental Treatment1 Intervention
Participants receive 1 dose of Scopolamine 0.4 mg delivered via a intranasal nebulizer developed by Creare LLC.
Group II: ChairExperimental Treatment2 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Scopolamine
FDA approved
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor
522 Previous Clinical Trials
2,542,464 Total Patients Enrolled
Jay C Buckey, Ph.DPrincipal InvestigatorDartmouth-Hitchcock Medical Center

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04999449 — Phase 1
Motion Sickness Research Study Groups: Chair, Pharmacokinetic
Motion Sickness Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04999449 — Phase 1
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04999449 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the minimum age threshold for this clinical trial eighteen years or older?

"This clinical trial has a designated age range for enrollment, where patients must be at least 21 years of age and no more than 49."

Answered by AI

How many people are currently involved in this research experiment?

"This trial has stopped recruiting participants; it was listed as of January 24th 2022 and last updated on October 22nd 2022. In case you're looking for other clinical trials, there are 5 studies currently enrolling patients with airsickness and a further 7 requiring volunteers to test Scopolamine's efficacy."

Answered by AI

Are participants being accepted for this trial at present?

"The data on clinicaltrials.gov shows that this medical research project, initially posted in January 24th 2022, is no longer seeking participants. However, it should be noted twelve other trials are still actively enrolling at the present moment."

Answered by AI

What can you tell me regarding prior experiments with Scopolamine?

"Currently, 7 studies are exploring the potential of Scopolamine as a medication. One is in its final Phase 3 testing stage while 16 medical sites across Lebanon, New hampshire are actively running trials on this drug."

Answered by AI

What therapeutic purposes does Scopolamine typically serve?

"Scopolamine has been frequently utilized to treat nausea, and also preanesthetic medication, anesthetic premedication therapy, motion sickness."

Answered by AI

Could I be a candidate for this research endeavor?

"In order to be accepted into this research program, prospective participants must suffer from airsickness and belong in the 21 to 49-year age range. The total recruitment pool for this trial consists of 30 individuals."

Answered by AI

Are there any risks associated with Scopolamine use?

"Scopolamine's safety has only been studied to a limited degree, thus it was rated 1 on our scale. This reflects its status as an experimental medication in early-stage trials."

Answered by AI
~16 spots leftby Aug 2026