Effects of Electronic Cigarette Use on the Lungs
Effects of Electronic Cigarette Use on the Human Lung
This randomized pilot clinical trial studies the effects of electronic cigarettes on the
lungs. Studying the effects of electronic cigarettes on the lungs may provide the Food and
Drug Administration (FDA) and other government regulators with important information, which
may help in developing future regulations to make electronic cigarettes safer.
I. To conduct a pilot cross-sectional study of electronic (e)-cigarette (cig) users,
never-smokers, and smokers (n=30), assessing use patterns and biomarkers by bronchoscopies
using bronchoalveolar lavage (cell counts, inflammatory cytokines, and untargeted
metabolomics), and bronchial brushings for gene expression (micro ribonucleic acid [miRNA]
and messenger ribonucleic acid [mRNA]).
II. To conduct a 4 week pilot clinical trial of nicotine-free and flavor-free e-cig use in
regular smokeless tobacco (ST) users (n=30), randomized to e-cig use or control (no e-cig
use), and assess biomarkers as in Objective 1 by bronchoscopy at baseline and at 4 weeks
while on product (week 5 of trial).
PART I: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo bronchoscopy of the left lung over 30-60 minutes.
ARM II: Patients undergo bronchoscopy of the right lung over 30-60 minutes.
PART II: Patients who are regular ST users are then randomized to 1 of 2 arms.
ARM A: Patients receive nicotine-free and flavor-free electronic cigarettes and instructed
to use them twice daily (BID) over a 2 hour period for 4 weeks.
ARM B: Patients receive no intervention.
In both arms, patients undergo a second bronchoscopy during week 5.
Current Smoker, Never Smoker, Tobacco Use Disorder
Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center, National Cancer Institute (NCI)