Biology of the Oral Epithelium of E-Cigarette Smokers
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 21 - 35 |
| Updated: | 5/3/2018 |
| Start Date: | January 2017 |
| End Date: | May 2019 |
| Contact: | Grace Mammen, BA, CCRP |
| Email: | gwm2004@med.cornell.edu |
| Phone: | 646-962-2672 |
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.
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.
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.
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.
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
We found this trial at
1
site
New York, New York 10021
Principal Investigator: Ronald G Crystal, MD
Phone: 646-962-2672
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