Alternate Nicotine Delivery Systems and Airway Epithelial Biology

Stopped early

Conditions studied: Smoking, Smoking Cessation

In brief

Cigarette smoking evokes major changes in the biology of the airway epithelium, the cell population that takes the brunt of the stress of cigarette smoke and the cell population central to the pathogenesis of chronic obstructive pulmonary disease (COPD) and lung cancer. The focus of this study is to identify the differences that two popular alternative nicotine delivery strategies, shisha and electronic cigarettes, have on the airway epithelium compared to cigarette smoking. We hypothesize that both alternative nicotine delivery strategies disorder airway epithelial biology, but in different ways than does cigarette smoking.

Key facts

Study ID

NCT01974063

Run by

Weill Medical College of Cornell University

People needed

96

Starts

2013-03-01

Expected to finish

2017-05-01

Last updated by the study team

2018-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Group A - Nonsmokers
• All study subjects should be healthy according to the Weill Cornell IRB protocol #1204012331 and be willing and able to provide informed consent for the follow up study with repeated bronchoscopies.
• Subjects will be male and female ≥18 yr of age.
• Nonsmoker is defined as someone who has smoked <100 cigarettes or <10 shisha pipes per lifetime and whose urine nicotine <2 ng/ml and/or urine cotinine <5 ng/ml, at entry into the study.
• Group B - Current cigarette smokers
• All study subjects should be healthy according to the Weill Cornell IRB protocol #1204012331 and willing and able to provide informed consent for the follow up study with repeated bronchoscopies.
• Subjects will be male and female ≥18 years of age.
• Active smoker is defined by self-report and urine nicotine >30 ng/ml and/or urine cotinine >50 ng/ml.
• Group C - Current shisha smokers
• All study subjects should be healthy according to the Weill Cornell IRB protocol #1204012331 and willing and able to provide informed consent for the follow up study with repeated bronchoscopies.
• Subjects will be male and female ≥18 yr of age.
• Shisha smoker is defined by self-report of smoking >4 pipes/wk and carboxyhemoglobin >2.5.
• Group D - Current smokers who stop smoking
• All study subjects should be healthy according to the Weill Cornell IRB protocol #1204012331 and willing and able to provide informed consent for the follow up study with repeated bronchoscopies.
• Subjects will be male and female ≥18 years of age.
• Current smoker is defined by self-report and urine nicotine >30 ng/ml and/or urine cotinine >50 ng/ml.
• Subjects must be a current smoker willing to stop smoking with no contra indications to taking varenicline.
• Group E - Current smokers who switch to electronic cigarettes
• All study subjects should be healthy according to the Weill Cornell IRB protocol #1204012331 and willing and able to provide informed consent for the follow up study with repeated bronchoscopies.
• Subjects will be male and female ≥18 years of age. Current smoker is defined by self-report and urine nicotine >30 ng/mL and/or urine cotinine >50 ng/ml.
• Subjects must be willing to switch from tobacco cigarettes to electronic cigarettes.

You may not qualify if…

• All exclusion criteria apply from the "Airway" (IRB#1204012331) protocol. Additional exclusion criteria specific to this protocol are as follows:
• Groups A-E
• No Weill Cornell (including GMS) students will be included, but students from other institutions may be included. A potential pool of Weill Cornell employees may enter this study provided that they are not under the oversight of the study PI or co-investigators.
• Groups D and E - Current smokers who stop smoking
• Subjects who are not, in the opinion of the responsible investigator, eligible to take smoking cessation medication due to major depressive and/or other significant psychiatric disorder.

Where it is running

• Rockefeller University Hospital — New York, New York, United States
• Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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