Effects of Electronic Cigarette Use on the Lungs

NCT ID: NCT02596685


Title
Effects of Electronic Cigarette Use on the Human Lung
Purpose
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.
Details
PRIMARY OBJECTIVES: 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). OUTLINE: 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.
Conditions
Current Smoker, Never Smoker, Tobacco Use Disorder
Keywords
Source
Ohio State University Comprehensive Cancer Center
Sponsors
Ohio State University Comprehensive Cancer Center, National Cancer Institute (NCI)
Status
Recruiting
Acronym
Last Updated
07 Jul 2016
URL
Official Link
Locations
United States