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To develop a better way to administer anti-motion sickness medications using an intranasal nebulizer.
An aqueous scopolamine formulation is being administered via a nebulizer and the pharmacokinetics of the drug are being measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacokinetic | Experimental | Participants receive 1 dose of Scopolamine 0.4 mg delivered via a intranasal nebulizer developed by Creare LLC. |
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| Chair | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scopolamine | Drug | Intranasal scopolamine at 0.2 mg or 0.4 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximal concentration for scopolamine after intranasal administration (Tmax) | 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. | Baseline, 180 minutes |
| Side effects of intranasal scopolamine, as measured through a questionnaire with a subjective rating scale | 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 | 180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness in reducing motion sickness as measured by duration of chair ride. | The degree of motion sickness will be assessed by measuring the total number of minutes the subject rides in the chair before stopping | Baseline, end of chair ride (maximum of 20 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay C Buckey, Ph.D | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
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| ID | Term |
|---|---|
| D009041 | Motion Sickness |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012601 | Scopolamine |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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Pharmacokinetic study followed by double-blind, placebo-controlled, dose-ranging design
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| Placebo |
| Drug |
Intranasal saline placebo |
|
| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |