Nebulizer Delivery of Intranasal Scopolamine
- Registration Number
- NCT04999449
- Lead Sponsor
- Dartmouth-Hitchcock Medical Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chair Placebo Participants receive 1 dose of Scopolamine 0.2 mg, 1 dose of Scopolamine 0.4 mg, and 1 dose of placebo saline delivered via the Creare LLC intranasal nebulizer. These dosages are all 1 week apart and the order is randomized. Pharmacokinetic Scopolamine Participants receive 1 dose of Scopolamine 0.4 mg delivered via a intranasal nebulizer developed by Creare LLC. Chair Scopolamine Participants receive 1 dose of Scopolamine 0.2 mg, 1 dose of Scopolamine 0.4 mg, and 1 dose of placebo saline delivered via the Creare LLC intranasal nebulizer. These dosages are all 1 week apart and the order is randomized.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States