Nebulizer Delivery of Intranasal Scopolamine

Launched by DARTMOUTH-HITCHCOCK MEDICAL CENTER · Aug 7, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new way to deliver a medication called scopolamine, which is used to help prevent motion sickness. The researchers want to see if using a nebulizer (a device that turns liquid medicine into a fine mist for inhalation) to administer scopolamine through the nose is an effective method. This trial is currently recruiting participants who are healthy adults aged 21 to 49, have a normal weight, and can provide written consent to join.

If you decide to participate, you will undergo a brief health check and answer questions about your medical history. It’s important to note that some people may not be eligible, such as those with certain allergies, recent surgeries, or specific health conditions like asthma or gastrointestinal disorders. Participants can expect to follow the study guidelines closely, and all necessary precautions will be taken to ensure safety throughout the trial.

Gender

ALL

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