ClinicalTrials.gg
CompletedNCT04999449Updated Aug 28, 2025

Nebulizer Delivery of Intranasal Scopolamine

A Phase 1 interventional study of Scopolamine and Placebo in Scopolamine and Motion Sickness, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-28.

Sponsored by Dartmouth-Hitchcock Medical Center · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2025, 1 year 6 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
21 Years to 49 Years
Sex
All
01

Study summary

To develop a better way to administer anti-motion sickness medications using an intranasal nebulizer.

Read the detailed description

An aqueous scopolamine formulation is being administered via a nebulizer and the pharmacokinetics of the drug are being measured.

02

Conditions studied

  • Scopolamine
  • Motion Sickness

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Keywords

  • Scopolamine
  • Motion Sickness
  • Space Physiology
03

In context

Motion Sickness

50 studies on the registry are indexed under Motion Sickness; 9 are open to participants now.

This study's enrollment of 14 is below the median of 59 across 44 interventional studies indexed under Motion Sickness.

Browse Motion Sickness studies →

Lead sponsor

Dartmouth-Hitchcock Medical Center is the lead sponsor of 488 studies on the registry; 71 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 21 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female
  • Adults age 21-49
  • Normal weight for body size, based on table
  • General good health, as determined by a verbally provided medical history
  • Normal brief neurological exam
  • Renal and hepatic function within normal ranges
  • Able to provide written to participate

Exclusion criteria

Exclusion Criteria:

  • Drug allergies to scopolamine or other belladonna alkaloid
  • Use of medications within 1 week of starting the study
  • Use of an drug within 30 days of starting the study
  • Tobacco smoking within the past year
  • Blood donation or significant blood loss within 30 days of starting the study
  • Significant gastrointestinal disorder (e.g. Crohn's Disease, ulcerative colitis, chronic constipation), asthma, glaucoma, prostate problems, urinary obstruction, or seizure disorders
  • History of alcohol or other drug abuse
  • Pregnancy or suspected pregnancy, or lactation (pregnancy will be confirmed with urine pregnancy testing prior to drug administration)
  • Consumption of grapefruit juice within 7 days of scopolamine (SCOP) administration
  • Nasal, nasal sinus, or nasal mucosa surgery within 90 days prior to study initiation
  • Other significant surgeries within 90 days
  • Significant deviated septum that blocks air flow in one nostril
  • Rhinitis, sinus infection, severe allergies, and other upper respiratory infections within 30 days prior to the study
  • Current use of an intranasal medication
  • Wheezing or other respiratory problem
  • Unable to consent
  • Prisoner
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Pharmacokinetic

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

    Drug: Scopolamine

  • Experimental
    Chair

    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.

    Drug: Scopolamine · Drug: Placebo

Interventions

  • Intranasal scopolamine at 0.2 mg or 0.4 mg

  • DrugPlacebo

    Intranasal saline placebo

06

What researchers measure

Primary outcomes

  1. Time to maximal concentration for scopolamine after intranasal administration (Tmax)

    Plasma scopolamine concentrations will be measured using an liquid chromatography-mass spectrometry (LC- MS) assay. Tmax is measured in minutes to reach the maximum concentration.

    Time frame: Baseline, 180 minutes

  2. Side effects of intranasal scopolamine, as measured through a questionnaire with a subjective rating scale

    A questionnaire will be administered asking about the participant's side effect profile after taking intranasal scopolamine. The questionnaire will have a subjective rating scale of 0-10 on the potential scopolamine side effects expected

    Time frame: 180 minutes

Secondary outcomes

  1. Effectiveness in reducing motion sickness as measured by duration of chair ride.

    The degree of motion sickness will be assessed by measuring the total number of minutes the subject rides in the chair before stopping

    Time frame: Baseline, end of chair ride (maximum of 20 minutes)

07

Study locations

1 site
  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2022 to primary completion in May 2025, 39 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 2, 2021
First posted
Aug 10, 2021
StartActual
Jan 24, 2022
Primary completionActual
May 7, 2025
CompletionActual
May 7, 2025
Last update
Aug 28, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04999449
Responsible party
Jay C. Buckey Jr. (Professor of Medicine, Dartmouth-Hitchcock Medical Center) — Principal investigator
First posted
Aug 10, 2021
Start date
Jan 24, 2022
Primary completion
May 7, 2025
Completion
May 7, 2025
Last update
Aug 28, 2025

Study contacts

Jay C Buckey, Ph.D
principal investigator · Dartmouth-Hitchcock Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Scopolamine

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