Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Effects of Electronic Cigarette Use on the Lungs

Protocol: OSU-15098

Full Title

Effects of Electronic Cigarette Use on the Human Lung

Purpose

This randomized pilot clinical trial studies the effects of electronic cigarettes on the lungs. Studying the effects of electronic cigarettes on the lungs may provide the Food and Drug Administration (FDA) and other government regulators with important information, which may help in developing future regulations to make electronic cigarettes safer.

Study Objective

PRIMARY OBJECTIVES:

I. To conduct a pilot cross-sectional study of electronic (e)-cigarette (cig) users, never-smokers, and smokers (n=30), assessing use patterns and biomarkers by bronchoscopies using bronchoalveolar lavage (cell counts, inflammatory cytokines, and untargeted metabolomics), and bronchial brushings for gene expression (micro ribonucleic acid [miRNA] and messenger ribonucleic acid [mRNA]).

II. To conduct a 4 week pilot clinical trial of nicotine-free and flavor-free e-cig use in regular smokeless tobacco (ST) users (n=30), randomized to e-cig use or control (no e-cig use), and assess biomarkers as in Objective 1 by bronchoscopy at baseline and at 4 weeks while on product (week 5 of trial).

OUTLINE:

PART I: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo bronchoscopy of the left lung over 30-60 minutes.

ARM II: Patients undergo bronchoscopy of the right lung over 30-60 minutes.

PART II: Patients who are regular ST users are then randomized to 1 of 2 arms.

ARM A: Patients receive nicotine-free and flavor-free electronic cigarettes and instructed to use them twice daily (BID) over a 2 hour period for 4 weeks.

ARM B: Patients receive no intervention.

In both arms, patients undergo a second bronchoscopy during week 5.

Are you eligible?

Inclusion Criteria:

Aim 1 only: 1) smokers who smoke at least 10 cigarettes per day with a stable smoking pattern of at least 6 months and no prior e-cig use within one year; smoking status will be confirmed by salivary cotinine; subjects with at least 10 ng/ml cotinine in their saliva being considered smokers; 2) e-cig users who report using e-cigs daily for 3 months with at least one nicotine-containing cartridge/day or 1 ml of liquid/day; they should have not smoked a cigarette for at least one year; 3) non-smokers who have smoked less than 100 cigarettes in their lifetime and not for at least 1 year, and not have used an e-cig for at least 1 year; lack of regular smoking will be confirmed by salivary cotinine

Aim 2 only: Smokeless tobacco users who use ST daily (>= 6 dips or pouches/day) for at least 6 months and no other tobacco use or e-cig use for at least 1 year (ST use will be confirmed by salivary cotinine), and in good physical and mental health; no serious quit attempts in the last three months particularly for those randomized to the control condition

No unstable and significant medical conditions as determined by medical history (to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures)

Able to read adequately to complete the survey and related study documents or give consent

Subject has provided written informed consent to participate in the study

Exclusion Criteria:

Immune system disorders, pulmonary diseases (e.g., asthma within the prior 5 years, acute bronchitis within 1 year, chronic obstructive pulmonary disease [COPD], chronic bronchitis, and restrictive lung disease), clinically diagnosed kidney or liver diseases, or any other medical disorders that will increase the risk from bronchoscopy, affect biomarker data, or increase risk of an adverse effect from e-cig use; all subjects are screened by a pulmonologist obtaining a medical history and a physical examination (heart, lungs and oral cavity) to ensure no increased risk from bronchoscopy or e-cig use

General anesthesia within one year

Use of inhalant medications

Allergies to study medications, such as, lidocaine, Versed, or Cetacaine

Bronchoscopy or any other lung procedure for any reason within the previous year

Current or recent (within three months) alcohol or drug abuse problems, including marijuana use within prior year, assessed via the Drug Use Questionniare-1 month

Other tobacco use (e.g., combustible products, vapors, etc.) within the last 3 months

Other tobacco use within the past year for 7 consecutive days or 14 times

Currently using nicotine replacement or other tobacco cessation products or intention to quit in next three months

Pregnant or breastfeeding - if the subject is female, the investigator will provide a urine pregnancy test at no cost to the subject; the subject will take the pregnancy test immediately before participating in this study

Unable to read for comprehension or completion of study documents