Clincosm LogoSign in Get a demo

Nebulizer Delivery of Intranasal Scopolamine

Sponsor
Dartmouth-Hitchcock Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04999449
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
48
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Pharmacokinetic study followed by double-blind, placebo-controlled, dose-ranging designPharmacokinetic study followed by double-blind, placebo-controlled, dose-ranging design
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Nebulizer Delivery of Intranasal Scopolamine
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2026
Anticipated Study Completion Date :
Aug 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pharmacokinetic

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

Drug: Scopolamine
Intranasal scopolamine at 0.2 mg or 0.4 mg
Experimental: Chair

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.

Drug: Scopolamine
Intranasal scopolamine at 0.2 mg or 0.4 mg

Drug: Placebo
Intranasal saline placebo

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 49 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756

Sponsors and Collaborators

  • Dartmouth-Hitchcock Medical Center

Investigators

  • Principal Investigator: Jay C Buckey, Ph.D, Dartmouth-Hitchcock Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jay C. Buckey Jr., Professor of Medicine, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT04999449
Other Study ID Numbers:
  • STUDY02001115
First Posted:
Aug 10, 2021
Last Update Posted:
Sep 14, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Jay C. Buckey Jr., Professor of Medicine, Dartmouth-Hitchcock Medical Center
Scopolamine
Motion Sickness
Space Physiology
Additional relevant MeSH terms:
Motion Sickness
Scopolamine
Butylscopolammonium Bromide

Study Results

No Results Posted as of Sep 14, 2021