Nebulizer Delivery of Intranasal Scopolamine

NCT ID: NCT04999449

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-24
• Study Completion Date: 2025-05-07

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.

Conditions

Scopolamine; Motion Sickness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pharmacokinetic

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

Group Type: EXPERIMENTAL

Scopolamine

Intervention Type: DRUG

Intranasal scopolamine at 0.2 mg or 0.4 mg

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.

Group Type: EXPERIMENTAL

Scopolamine

Intervention Type: DRUG

Intranasal scopolamine at 0.2 mg or 0.4 mg

Placebo

Intervention Type: DRUG

Intranasal saline placebo

Interventions

Scopolamine

Intranasal scopolamine at 0.2 mg or 0.4 mg

Intervention Type: DRUG

Placebo

Intranasal saline placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jay C. Buckey Jr.

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jay C Buckey, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

Other Identifiers

STUDY02001115

Identifier Type: -

Identifier Source: org_study_id