Nebulizer delivery of scopolamine for motion sickness
Nebulizer Delivery of Intranasal Scopolamine
PHASE1 · Dartmouth-Hitchcock Medical Center · NCT04999449
This study is testing if using a nebulizer to deliver scopolamine can help adults aged 21-49 with motion sickness feel better compared to a placebo.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 21 Years to 49 Years |
| Sex | All |
| Sponsor | Dartmouth-Hitchcock Medical Center (other) |
| Locations | 1 site (Lebanon, New Hampshire) |
| Trial ID | NCT04999449 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the administration of anti-motion sickness medication by using an intranasal nebulizer to deliver an aqueous formulation of scopolamine. Participants will receive either the scopolamine treatment or a placebo, and the pharmacokinetics of the drug will be measured to assess its effectiveness. The study focuses on adults aged 21-49 who are in good health and meet specific eligibility criteria. The goal is to determine if this method provides a better alternative for managing motion sickness.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 21-49 with normal weight and no significant medical conditions.
Not a fit: Patients with a history of drug allergies to scopolamine or other contraindicated conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a more effective and convenient way to manage motion sickness for patients.
How similar studies have performed: While the approach of using nebulizers for drug delivery is established, the specific application of intranasal scopolamine for motion sickness is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lebanon, New Hampshire
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (RECRUITING)
Study contacts
- Principal investigator: Jay C Buckey, Ph.D — Dartmouth-Hitchcock Medical Center
- Study coordinator: Samantha M Leigh, BA
- Email: samantha.m.leigh@dartmouth.edu
- Phone: (603) 646-5327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Scopolamine, Motion Sickness, Space Physiology