COMPLETED

Nebulizer Delivery of Intranasal Scopolamine

Conditions

Scopolamine Motion Sickness Space Physiology

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Nebulizer Delivery of Intranasal Scopolamine

Quick Facts

Study Start:2022-01-24

Study Completion:2025-05-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04999449

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 49 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Principal Investigator

Jay C Buckey, Ph.D

PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Study Locations (Sites)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756

United States

Collaborators and Investigators

Sponsor: Dartmouth-Hitchcock Medical Center

Jay C Buckey, Ph.D, PRINCIPAL_INVESTIGATOR, Dartmouth-Hitchcock Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-24

Study Completion Date2025-05-07

Study Record Updates

Study Start Date2022-01-24

Study Completion Date2025-05-07

Terms related to this study

Keywords Provided by Researchers

Scopolamine
Motion Sickness
Space Physiology

Additional Relevant MeSH Terms

Scopolamine
Motion Sickness