Study Stopped
Grant Ended
Sponsor study identifier
Secondary identifiers
observational
96
1 country
2
Study Start
March 2013
Actual (reported)Primary Completion
May 2017
Actual (reported)Study Completion
May 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 20, 2012
Actual (reported)March 2013
Actual (reported)November 1, 2013
Actual (reported)May 2017
Actual (reported)May 2017
Actual (reported)Number of participants with gene expression changes in the small airway epithelium (SAE)
We will measure the effect that shisha smoking has on the small airway epithelium (SAE) by measuring parameters such as the SAE gene expression, DNA methylation, telomere length and cilia length in "pure shisha smokers" (i.e., non-cigarette smokers.) We will compare these parameters to the same parameters measured in non-smokers and cigarette smokers.
Study individuals will be enrolled in the study for three months.
Number of participants with gene expression changes in the airway epithelium
Study individuals will be enrolled in the study for three months.
Subjects have 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.
Defined by self-report and urine nicotine \>30 ng/mL and/or urine cotinine \>50 ng/ml.
Defined by self-report of smoking \>4 pipes/wk and carboxyhemoglobin \>2.5.
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. Subjects will stop smoking after the baseline bronchoscopy, and switch to taking a smoking cessation medication called varenicline. We will provide subjects with the smoking cessation medication as part of this study. They will also receive phone calls to help with smoking cessation counseling.
Defined by self-report and urine nicotine \>30 ng/ml and/or urine cotinine \>50 ng/ml. Must be willing to switch from tobacco cigarettes to electronic cigarettes. The switch will occur after the baseline bronchoscopy. The nicotine dose that will be given to each subject will be determined by the study physician based on the urine smoking metabolite test. It will be adjusted depending on whether the subject is a light smoker or heavy smoker (Light smoker defined as having either a urine nicotine value from 2ng/ml-1000ng/ml or a urine cotinine value from 5ng/ml-1000ng/ml. Heavy smoker is defined as having either a urine nicotine or cotinine value of over 1000ng/ml.) We will provide the subjects with the electronic cigarettes to use as part of this study.
New York Metropolitan area residents
Rockefeller University Hospital
New York, New York, 10065, United States
Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine
New York, New York, 10065, United States
Analysis performed will be completed per the "Airway" (IRB#1204012331) protocol.
Ronald G Crystal, MD
Weill Medical College of Cornell University
96 participants (actual enrollment reported by the registry).
First Submitted
December 20, 2012
First Posted
November 1, 2013
Study Start
March 2013
Actual (reported)A Randomized Trial to Implement the AHCPR Smoking Cessation Guideline
Contact the study team to confirm eligibility.
Primary Completion
May 2017
Actual (reported)Study Completion
May 2017
Actual (reported)Last Updated
May 3, 2018
Record last verified: 2018-04
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Source: ClinicalTrials.gov.
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