Biology of the Oral Epithelium of E-Cigarette Smokers

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Weill Cornell Medicine (WCM)

Status

Completed

Conditions

Healthy

Study type

Observational

Funder types

Other

Identifiers

NCT03028558
1512016796

Details and patient eligibility

About

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.

Full 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.

Enrollment

105 patients

Sex

All

Ages

21 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

HEALTHY VOLUNTEER RESEARCH SUBJECTS:

Inclusion Criteria:

  • Males and females, ages 21 to 35
  • Must be capable of providing informed consent
  • Self-reported never-smokers of any type, including chewing tobacco, with current smoking status validated by the absence of nicotine metabolites in urine (nicotine <2 ng/ml and cotinine <5 ng/ml)
  • No bleeding diathesis
  • Normal physical examination
  • Good overall health without history of oral or lung disease
  • Normal routine laboratory evaluation, including general hematologic studies, general serologic/immunologic studies, general biochemical analyses, and urine analysis
  • Not taking any medications relevant to lung disease or having an effect on the airway epithelium
  • Normal chest X-ray (PA and lateral)
  • Normal electrocardiogram (sinus bradycardia, premature atrial contractions are permissible)
  • Females - not pregnant

Willingness to participate in the study

HEALTHY VOLUNTEER E-CIGARETTE SMOKING SUBJECTS:

Inclusion Criteria:

  • Males and females, ages 21 to 35
  • Must be capable of providing informed consent
  • E-cigarette smokers with current smoking status validated by nicotine metabolites in urine (nicotine >20 ng/ml and cotinine >30 ng/ml)
  • No bleeding diathesis
  • Normal routine laboratory evaluation, including general hematologic studies, general serologic/immunologic studies, general biochemical analyses, and urine analysis
  • Good overall health without history of oral disease
  • Normal spirometry
  • All individuals have chest X-ray (PA and lateral)
  • Normal electrocardiogram (sinus bradycardia, premature atrial contractions are permissible)
  • Females - not pregnant
  • Willingness to participate in the study

Exclusion criteria

HEALTHY VOLUNTEER RESEARCH SUBJECTS:

Exclusion Criteria:

  • Unable to meet the inclusion criteria
  • Have smoked any form of tobacco
  • Current marijuana smokers (within the last three months)
  • Current active infection or acute illness of any kind
  • Evidence of malignancy, including oral cancer

Current pregnancy

HEALTHY VOLUNTEER E-CIGARETTE SMOKING SUBJECTS:

Exclusion criteria:

  • Unable to meet the inclusion criteria
  • Have smoked any form of tobacco
  • Current marijuana smokers (within the last three months)
  • Current active infection or acute illness of any kind
  • Evidence of malignancy, including oral cancer
  • Current Pregnancy

Trial design

105 participants in 2 patient groups

HEALTHY VOLUNTEER RESEARCH SUBJECTS
Description:
Healthy as defined by those not having lung disease and inclusive of: all races, ethnicities, sex, HIV status, smoking status and multiple birth status, etc., within the general population. Between the ages of 21-35 years old.
HEALTHY E-CIGARETTE SMOKING SUBJECTS
Description:
Criteria is identical to the healthy never-smoker group except that they must have a history of smoking e-cigarettes >5 days/wk for a minimum of 6 months with no prior traditional tobacco exposure.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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