Alternate Nicotine Delivery Systems and Airway Epithelial Biology

Smoking Cessation Clinical Trial

Official title: Alternate Nicotine Delivery Systems and Airway Epithelial Biology

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

Hypothesis and Research Questions We hypothesize that shisha smoking and electronic cigarettes both disorder airway biology, but this disordered biology differs from that resulting from cigarette smoking, suggesting that these alternative nicotine delivery methods will cause lung disease, but perhaps with phenotypes different from that of cigarette smoking.

Aim 1: To assess the hypothesis that shisha smoking disorders the biology of the airway epithelium, but that these changes are distinct from that of cigarette smokers.

Aim 2: To evaluate the hypothesis that when the smoker switches from smoking cigarettes to smoking electronic cigarettes, there is a partial normalization of the disordered airway epithelial biology, but that this partial normalization is different from that associated from complete cessation of cigarette smoking.

Standard and Experimental Procedures

All of the study populations and assessments to be carried out in this protocol are already covered under the IRB approved protocol, "Collection of Airway, Blood and/or Urine Specimens from Subjects for Research Studies" (IRB #1204012331); the only purpose of this protocol is to formalize the timing of assessments so that the underlying hypothesis can be assessed.

The above protocol is designed to assess gene expression in lung cells of nonsmokers, smokers and ex-smokers. The purpose of the present study is to asses if shisha smoking and electronic cigarettes both disorder airway biology, and see if this disordered biology differs from that resulting from cigarette smoking, suggesting that these alternative nicotine delivery methods will cause lung disease, but perhaps with phenotypes different from that of cigarette smoking.

This new protocol will use our existing IRB approved protocol, "Collection of Airway, Blood and/or Urine Specimens from Subjects for Research Studies ("Airway")" (IRB #1204012331), for all of the assessments and procedures of this study. This protocol is designed to formalize the time points at which we carry out the various test parameters (see Table II for a timeline of the study parameters). Recruitment for this protocol will be from the cohort of individuals who are recruited for the "Airway" study. Research subjects recruited into this protocol, will sign both the "Airway" informed consent form and also the consent form for this protocol.

The standard clinical care of our pulmonary physicians is to encourage all smokers to stop smoking; hence, all research participants who smoke will be encouraged to stop smoking. If they decide to do so, they will receive standard of care smoking cessation aids including counseling and medications.

Subjects enrolled in Group E of the study will receive an alternative nicotine delivery method such as electronic cigarettes. ;

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation

• NCT number: NCT01974063
• Study type: Observational
• Source: Weill Medical College of Cornell University
• Status: Terminated
• Start date: March 2013
• Completion date: May 2017