Biology of the Oral Epithelium of E-Cigarette Smokers

Status: Completed
Location: See location...
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 35
Healthy Volunteers: t
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• HEALTHY VOLUNTEER RESEARCH SUBJECTS:

• 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:

• 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

Locations
United States
New York
Department of Genetic Medicine, Weill Cornell Medical College
New York
Time Frame
Start Date: 2016-04-12
Completion Date: 2021-01-21
Participants
Target number of participants: 105
Treatments
HEALTHY VOLUNTEER RESEARCH SUBJECTS
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
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.
Sponsors
Leads: Weill Medical College of Cornell University

This content was sourced from clinicaltrials.gov