Biology of the Oral Epithelium of E-Cigarette Smokers

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.

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Key information

Conditions

Healthy Behavior Smoking Vaping

Age range

21 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Genetic Medicine, Weill Cornell Medical College

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

The biology of participants oral epithelial cells

Time frame: 1-2 months

Biopsies will be collected from the buccal mucosa of chronic EC smokers and healthy nonsmoker controls, none of whom have a history of smoking any tobacco products

Secondary outcomes

The biology of the genes of the oral epithelium

Time frame: 1-2 months

Biopsies will be collected from the buccal mucosa of chronic EC smokers and healthy nonsmoker controls, none of whom have a history of smoking any tobacco products

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2021
First posted: Jan 23, 2017
Registry last updated: May 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed