- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03028558
Biology of the Oral Epithelium of E-Cigarette Smokers
April 30, 2021 updated by: Weill Medical College of Cornell University
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
105
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10021
- Department of Genetic Medicine, Weill Cornell Medical College
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The investigators plan recruit the EC smoking (also called "vaping") population, and have experience recruiting from the extensive network of EC shops and vaping "bars" in the New York City metropolitan area, providing ample access to young adult, sole EC smokers.
The control groups will be age-, gender- and ethnicity-matched healthy nonsmokers.
Based on our experience with this population, the investigators know that the variables of EC smoking history (brand, flavorings, length and extent of EC smoking history) demand that there is sufficient "n" to power the analysis.
In this regard, the study population will include n=125, including n=100 EC smokers and a control group of n=25 healthy nonsmokers.
Between the ages of 21-35 years old.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1-2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1-2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 12, 2016
Primary Completion (Actual)
February 12, 2019
Study Completion (Actual)
January 21, 2021
Study Registration Dates
First Submitted
January 11, 2017
First Submitted That Met QC Criteria
January 19, 2017
First Posted (Estimate)
January 23, 2017
Study Record Updates
Last Update Posted (Actual)
May 4, 2021
Last Update Submitted That Met QC Criteria
April 30, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 1512016796
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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