Acute Effects of E-Cigarette Aerosol Inhalation

University of Pennsylvania

Status and phase: Completed; Early Phase 1

Conditions: Biochemical Markers; Endothelial Dysfunction

Treatments: Drug: Electronic Cigarette Aerosol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03479203

R01HL139358 (U.S. NIH Grant/Contract)

828195

Details and patient eligibility

About

This study comprises a portion of a larger study designed to compare results of vascular function in non-smokers to vascular function in healthy smokers chronically exposed to nicotinized electronic cigarette aerosol versus conventional cigarettes.

Full description

Here, we 1) investigate the acute effects of non-nicotinized e-cigarette aerosol inhalation in nonsmokers in terms of blood-based markers of inflammation and oxidative stress, and 2) evaluate their association with hemodynamic-metabolic MRI parameters quantifying peripheral vascular reactivity, cerebrovascular reactivity, and aortic stiffness.

Enrollment: 31 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI of 18.5 - 30

Exclusion criteria

• Cancer
• HIV
• Mental illness
• Overt cardio- or neurovascular disease (prior heart attack, stroke, transient ischemic attacks)
• Serious arrhythmias
• Bronchospastic disease
• Upper respiratory tract infection within the past six weeks
• Chronic medication or antibiotics
• Claustrophobia / contraindications for MRI

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Healthy, Non-Smokers

Experimental group

Description:

Non-nicotinized electronic cigarette aerosol (16 2-second long puffs)

Treatment:

Drug: Electronic Cigarette Aerosol