Effects of Electronic Cigarette Use on the Lungs
Condition: Current Smoker; Never Smoker; Tobacco Use Disorder; Former Smoker; E-cig User
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      1) To conduct a pilot cross-sectional study of e-cig users (n=16), never-smokers (n=8 -
      completed under an earlier version of the protocol before never-smokers were used for Aim 2),
      (newly added n=15), former smokers who have quit smoking and are currently not using e-cigs
      (n=15), former smokers who switched to e-cigs (n=15) and smokers (n=16) [total n=85), to
      better determine the influence of e-cig and smoking use (i.e., power) between never smokers
      and e-cig users, and to compare former smokers with e-cig use, and assessing use patterns and
      biomarkers by bronchoscopies using bronchioalveolar lavage (cell counts, inflammatory
      cytokines, untargeted metabolomics, and microbiome assessment), bronchial brushings (miRNA
      and mRNA expression, DNA methylation, acrolein DNA adducts, and mitochondrial DNA mutations
      and copy number variation), blood and urine to assess exposure to the e-cigs ingredients,
      saliva for oral microbiome assessment, and nasal brushing and nasal lavages for the lung
      toxicity as examined in this study as surrogate markers for the lung. We will also measure
      fractional exhaled nitric oxide (FeNO) as a marker of lower airway inflammation; and,

      1a) Conduct a supplemental contamination study to measure if bacteria from oral cavity, nasal
      cavity or oropharynx may contaminate BAL fluid recovered during the bronchoscopy (n=30).
      Contamination analyses will measure if bacterial species found in oral cavity, nasal cavity
      and oropharynx are recovered in BAL. Contamination analyses will not examine differences
      between groups.

      2) To conduct a 4 week pilot clinical trial of nicotine-free and flavor-free e-cig use in
      never-smokers (n=30), randomized to e-cig use (n=15) or control (no e-cig use) (n=15), and
      assess biomarkers as in Aim 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 never-smokers 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.
    

Intervention name(s): Bronchoscopy; Electronic Cigarette; Laboratory Biomarker Analysis; Questionnaire Administration
Intervention type(s): Procedure; Other; Other; Other
Intervention description(s): Undergo bronchoscopy; Given nicotine-free and flavor-free electronic cigarettes; Correlative studies; Ancillary studies
Other intervention name(s): e-Cigarette; Electronic Nicotine Delivery System
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science