Nebulizer Delivery of Intranasal Scopolamine

Dartmouth Health

Status and phase: Completed; Phase 1

Conditions: Scopolamine; Motion Sickness

Treatments: Drug: Placebo; Drug: Scopolamine

Study type: Interventional

Funder types: Other

Identifiers

NCT04999449

STUDY02001115

Details and patient eligibility

About

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

Full description

An aqueous scopolamine formulation is being administered via a nebulizer and the pharmacokinetics of the drug are being measured.

Enrollment: 14 patients

Sex: All

Ages: 21 to 49 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Pharmacokinetic

Experimental group

Description:

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

Treatment:

Drug: Scopolamine

Chair

Experimental group

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.

Treatment:

Drug: Scopolamine

Drug: Placebo