Biology of the Oral Epithelium of E-Cigarette Smokers
Completed
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT03028558
- Run by
- Weill Medical College of Cornell University
- People needed
- 105
- Starts
- 2016-04-12
- Expected to finish
- 2021-01-21
- Last updated by the study team
- 2021-05-04
Who can join
Age: 21 and older, up to 35. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Department of Genetic Medicine, Weill Cornell Medical College — New York, New York, United States
Full record on ClinicalTrials.gov
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