HealthyNCT03028558
Biology of the Oral Epithelium of E-Cigarette Smokers
An observational study of Healthy, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2016to 21 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
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- 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
- 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
Who cannot join
- HEALTHY VOLUNTEER RESEARCH SUBJECTS:
- 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
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- Current pregnancy
- HEALTHY VOLUNTEER E-CIGARETTE SMOKING SUBJECTS:
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Genetic Medicine, Weill Cornell Medical College
New York, New York, 10021
About this study
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.
Read the 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.
- Conditions
- Healthy
- Keywords
- Electronic Cigarettes, Healthy Volunteers, E-Cigarettes Smokers, E-Cigarettes
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-2 months
Secondary outcomes (1)
The biology of the genes of the oral epithelium
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
Measured: 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start12 Apr 2016
- Primary completion12 Feb 2019
- Study completion21 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald G Crystal, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028558
- Sponsor's protocol ID
- 1512016796
- Status last verified
- Apr 2021
- First submitted
- 11 Jan 2017
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biology of the Oral Epithelium of E-Cigarette Smokers
- ClinicalTrials.gov ID
- NCT03028558
- Acronym / sponsor ID
- 1512016796
- Conditions
- Healthy
- Keywords
- Electronic Cigarettes, Healthy Volunteers, E-Cigarettes Smokers, E-Cigarettes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 12 Apr 2016 (actual)
- Primary completion
- 12 Feb 2019 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (25 listed)
- 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
Key exclusion criteria (14 listed)
- HEALTHY VOLUNTEER RESEARCH SUBJECTS:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcome
The biology of the genes of the oral epithelium
Time frame: 1-2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald G Crystal, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The biology of participants oral epithelial cells (time frame: 1-2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.