Biology of the Oral Epithelium of E-Cigarette Smokers

NCT03028558 | Completed

• 1 other identifier: 1512016796
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Electronic Cigarettes; Healthy Volunteers; E-Cigarettes Smokers; E-Cigarettes

Outcome Measures

Primary Outcomes (1)

• The biology of participants oral epithelial cells

  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 Outcomes (1)

• The biology of the genes of the oral epithelium

  1-2 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• HEALTHY VOLUNTEER RESEARCH SUBJECTS:
• 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:
• Males and females, ages 21 to 35

You may not qualify if:

• HEALTHY VOLUNTEER RESEARCH SUBJECTS:
• 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:
• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Department of Genetic Medicine, Weill Cornell Medical College

New York, New York, 10021, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Specimens collected may include blood, urine and oral epithelium samples from consenting subjects. Subjects will include both e-cigarette smoking individuals and healthy control subjects.

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Officials

• Ronald G Crystal, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 23, 2017
• Study Start: April 12, 2016
• Primary Completion: February 12, 2019
• Study Completion: January 21, 2021
• Last Updated: May 4, 2021

Record last verified: 2021-04

Locations

US (1)