Nebulizer Delivery of Intranasal Scopolamine

• Status: Not yet recruiting
• Trial end date: 2026-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Treatments: Butylscopolammonium Bromide; Scopolamine

Criteria

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