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Nebulizer Delivery of Intranasal Scopolamine

Primary Purpose

Scopolamine, Motion Sickness

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Scopolamine
Placebo
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scopolamine focused on measuring Scopolamine, Motion Sickness, Space Physiology

Eligibility Criteria

21 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dartmouth-Hitchcock Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pharmacokinetic

Chair

Arm Description

Participants receive 1 dose of Scopolamine 0.4 mg delivered via a intranasal nebulizer developed by Creare LLC.

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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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

Full Information

First Posted
August 2, 2021
Last Updated
July 28, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04999449
Brief Title
Nebulizer Delivery of Intranasal Scopolamine
Official Title
Nebulizer Delivery of Intranasal Scopolamine
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2022 (Actual)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
To develop a better way to administer anti-motion sickness medications using an intranasal nebulizer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scopolamine, Motion Sickness
Keywords
Scopolamine, Motion Sickness, Space Physiology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Pharmacokinetic study followed by double-blind, placebo-controlled, dose-ranging design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pharmacokinetic
Arm Type
Experimental
Arm Description
Participants receive 1 dose of Scopolamine 0.4 mg delivered via a intranasal nebulizer developed by Creare LLC.
Arm Title
Chair
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Scopolamine
Intervention Description
Intranasal scopolamine at 0.2 mg or 0.4 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intranasal saline placebo
Primary Outcome Measure Information:
Title
Time to maximal concentration for scopolamine after intranasal administration (Tmax)
Description
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.
Time Frame
Baseline, 180 minutes
Title
Side effects of intranasal scopolamine, as measured through a questionnaire with a subjective rating scale
Description
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
Time Frame
180 minutes
Secondary Outcome Measure Information:
Title
Effectiveness in reducing motion sickness as measured by duration of chair ride.
Description
The degree of motion sickness will be assessed by measuring the total number of minutes the subject rides in the chair before stopping
Time Frame
Baseline, end of chair ride (maximum of 20 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha M Leigh, BA
Phone
(603) 646-5327
Email
samantha.m.leigh@dartmouth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Shireen Geimer, MS
Phone
(603) 646-5331
Email
Shireen.Geimer@dartmouth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay C Buckey, Ph.D
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Nebulizer Delivery of Intranasal Scopolamine

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