Biology of the Oral Epithelium of E-Cigarette Smokers
Condition: Healthy
Study type: Observational

Summary: 
      Electronic cigarettes (EC) are battery powered nicotine delivery devices that aerosolize
      nicotine and other flavor constituents. Despite the increasing use of EC, little attention
      has been paid to their possible adverse effects on human health. Theoretically, the risk
      relates to nicotine per se and/or the propellants or contaminants in the EC aerosol. The
      hypothesis underlying the proposal is that chronic EC smoking disorders the biology of the
      oral epithelium, the first cell population exposed to inhaled EC vapors. Using a
      cross-sectional, cohort-comparison of EC smokers compared to age-, gender- and
      ethnicity-matched never smokers, the investigators propose to assess the oral epithelium
      obtained by punch biopsy or brushing from 100 EC smokers and 25 nonsmoker controls. The EC
      study cohort will be restricted to young adults (age 21-35 yr) with no prior history of
      tobacco smoking, but who have smoked EC for >6 months.
    

Detailed description: 
      There is compelling evidence to support this hypothesis: (1) EC vapors contain nicotine, the
      oral epithelium expresses nicotine receptors, and exposure of epithelia to nicotine activates
      the nicotine pathway; (2) EC vapors also contain chemical contaminants that can potentially
      effect oral epithelial biology; and (3) in vitro studies suggest that EC vapors modify
      epithelial biology and data generated by our laboratory demonstrates that even a brief, acute
      exposure of healthy nonsmokers to EC vapors induces significant changes in the airway
      epithelial transcriptome, including the expression of genes in the nicotine and p53 pathways.
      With the knowledge that disordering of cell biology occurs long before clinical disease,the
      investigators will evaluate the oral epithelium at the transcriptome (mRNA and miRNA) levels.
      They will then identify gene(s)/pathways/communities disordered by EC vapors.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The investigators plan recruit the EC smoking (also called "vaping") population, and have
        experience recruiting from the extensive network of EC shops and vaping "bars" in the New
        York City metropolitan area, providing ample access to young adult, sole EC smokers. The
        control groups will be age-, gender- and ethnicity-matched healthy nonsmokers. Based on our
        experience with this population, the investigators know that the variables of EC smoking
        history (brand, flavorings, length and extent of EC smoking history) demand that there is
        sufficient "n" to power the analysis. In this regard, the study population will include
        n=125, including n=100 EC smokers and a control group of n=25 healthy nonsmokers. Between
        the ages of 21-35 years old.
      
Biospecimen description: 
      Specimens collected may include blood, urine and oral epithelium samples from consenting
      subjects. Subjects will include both e-cigarette smoking individuals and healthy control
      subjects.
    
Keywords: Electronic Cigarettes; Healthy Volunteers; E-Cigarettes Smokers; E-Cigarettes