Motion Sickness, Scopolamine
Conditions
Keywords
Scopolamine, Motion Sickness, Space Physiology
Brief summary
To develop a better way to administer anti-motion sickness medications using an intranasal nebulizer.
Detailed description
An aqueous scopolamine formulation is being administered via a nebulizer and the pharmacokinetics of the drug are being measured.
Interventions
DRUGScopolamine
Intranasal scopolamine at 0.2 mg or 0.4 mg
DRUGPlacebo
Intranasal saline placebo
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pharmacokinetic study followed by double-blind, placebo-controlled, dose-ranging design
Eligibility
Sex/Gender
ALL
Age
21 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to maximal concentration for scopolamine after intranasal administration (Tmax) | Baseline, 180 minutes | 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. |
| Side effects of intranasal scopolamine, as measured through a questionnaire with a subjective rating scale | 180 minutes | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness in reducing motion sickness as measured by duration of chair ride. | Baseline, end of chair ride (maximum of 20 minutes) | The degree of motion sickness will be assessed by measuring the total number of minutes the subject rides in the chair before stopping |
Countries
United States
Outcome results
None listed