Nebulizer Delivery of Intranasal Scopolamine

Motion Sickness Clinical Trial

Official title:

Nebulizer Delivery of Intranasal Scopolamine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04999449
• Other study ID #: STUDY02001115
• Status: Recruiting
• Phase: Phase 1
• Start date: January 24, 2022
• Est. completion date: August 2026

Study information

• Verified date: July 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Samantha M Leigh, BA
• Phone: (603) 646-5327
• Email: samantha.m.leigh[@]dartmouth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Motion Sickness
• Scopolamine

Intervention

Drug:
• Scopolamine
Intranasal scopolamine at 0.2 mg or 0.4 mg
• Placebo
Intranasal saline placebo

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)