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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • New York
      • New York, New York, United States, 10021
        • Department of Genetic Medicine, Weill Cornell Medical College

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Weill Medical College of Cornell University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 21, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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