Nebulizer Delivery of Intranasal Scopolamine

NCT04999449 | Completed Phase 1 FDA Drug

• 1 other identifier: STUDY02001115
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Scopolamine; Motion Sickness

Keywords

Scopolamine; Motion Sickness; Space Physiology

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, 180 minutes

• 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

  180 minutes

Secondary Outcomes (1)

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

  Baseline, end of chair ride (maximum of 20 minutes)

Study Arms (2)

Pharmacokinetic

EXPERIMENTAL

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

Drug: Scopolamine

Chair

EXPERIMENTAL

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

Scopolamine DRUG

Intranasal scopolamine at 0.2 mg or 0.4 mg

Chair; Pharmacokinetic

Placebo DRUG

Intranasal saline placebo

Chair

Eligibility Criteria

• Age: 21 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Motion Sickness

Interventions

Scopolamine

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Jay C Buckey, Ph.D

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Pharmacokinetic study followed by double-blind, placebo-controlled, dose-ranging design

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 10, 2021
• Study Start: January 24, 2022
• Primary Completion: May 7, 2025
• Study Completion: May 7, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)