Nebulizer Delivery of Intranasal Scopolamine

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

Study Overview

• Status: Recruiting
• Conditions: Motion Sickness; Scopolamine
• Intervention / Treatment: Drug: Scopolamine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Samantha M Leigh, BA; Phone Number: (603) 646-5327; Email: samantha.m.leigh@dartmouth.edu
• Study Contact Backup: Name: Shireen Geimer, MS; Phone Number: (603) 646-5331; Email: Shireen.Geimer@dartmouth.edu

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Recruiting
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacokinetic; Participants receive 1 dose of Scopolamine 0.4 mg delivered via a intranasal nebulizer developed by Creare LLC.	Drug: Scopolamine; Intranasal scopolamine at 0.2 mg or 0.4 mg
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; Intranasal scopolamine at 0.2 mg or 0.4 mg; Drug: Placebo; Intranasal saline placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, end of chair ride (maximum of 20 minutes)

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: Jay C Buckey, Ph.D, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 7, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Motion Sickness; Scopolamine; Space Physiology
• Additional Relevant MeSH Terms: Motion Sickness; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Antiemetics; Gastrointestinal Agents; Adjuvants, Anesthesia; Mydriatics; Scopolamine; Butylscopolammonium Bromide
• Other Study ID Numbers: STUDY02001115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No