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OpenTrials
Completed

NCT Number: NCT04999449

Nebulizer Delivery of Intranasal Scopolamine

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

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Key information

Age range

21 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female
  • Adults age 21-49
  • Normal weight for body size, based on BMI 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 informed consent to participate

Exclusion criteria

  • Drug allergies to scopolamine or other belladonna alkaloid
  • Use of medications within 1 week of starting the study
  • Use of an investigational 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

Treatment and study plan

Scopolamine

Drug

Intranasal scopolamine at 0.2 mg or 0.4 mg

Placebo

Drug

Intranasal saline placebo

Primary outcomes

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

    Time frame: Baseline, 180 minutes

    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.

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

    Time frame: 180 minutes

    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

Secondary outcomes

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

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

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

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 10, 2021
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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