Clinical trial NCT04999449: Nebulizer Delivery of Intranasal Scopolamine
Official title: Nebulizer Delivery of Intranasal Scopolamine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Scopolamine
Motion Sickness
Keywords: Scopolamine
Motion Sickness
Space Physiology
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pharmacokinetic study followed by double-blind, placebo-controlled, dose-ranging design
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Time to maximal concentration for scopolamine after intranasal administration (Tmax)
timeFrame: Baseline, 180 minutes
measure: Side effects of intranasal scopolamine, as measured through a questionnaire with a subjective rating scale
timeFrame: 180 minutes
Secondary outcomes:
measure: Effectiveness in reducing motion sickness as measured by duration of chair ride.
timeFrame: Baseline, end of chair ride (maximum of 20 minutes)
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Jay C Buckey, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: