Alternate Nicotine Delivery Systems and Airway Epithelial Biology

NCT01974063 | Terminated DMC

• 2 other identifiers: 1208012965R01HL107882-02S1
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Smoking; Smoking Cessation

Keywords

Smoking; Smoking Cessation; Healthy Smoker; Shisha Smoker; Non-smoker

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Number of participants with gene expression changes in the airway epithelium

  Study individuals will be enrolled in the study for three months.

Study Arms (5)

A. Nonsmokers

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.

B.Current cigarette smokers

Defined by self-report and urine nicotine \>30 ng/mL and/or urine cotinine \>50 ng/ml.

C. Current shisha smokers

Defined by self-report of smoking \>4 pipes/wk and carboxyhemoglobin \>2.5.

D. smokers willing to quit

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.

E. Smokers switching to E-cigarettes

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

New York Metropolitan area residents

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Rockefeller University Hospital

New York, New York, 10065, United States

Location

Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine

New York, New York, 10065, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Analysis performed will be completed per the "Airway" (IRB#1204012331) protocol.

MeSH Terms

Conditions

Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Health 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: December 20, 2012
• First Posted: November 1, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 3, 2018

Record last verified: 2018-04

Locations

US (2)