Eligibility Details:
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 [150]. 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) former
smokers currently using nicotine-containing e-cigs who have completely switched to
e-cigs 1-5 years earlier, and previously smoked >10 cigs/day for >1 year. 4)
former-smokers who have quit smoking 1-5 years previously, and who previously smoked
>10 cigs/day for >1 year and no e-cig use for a year and <10 days in their lifetime.
5) never-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 NicAlert.
- Aim 2 only: 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. Participants should be in good
physical and mental health, particularly those randomized to the control condition;
- No unstable and significant medical conditions as determined by medical history (see
exclusion criteria below) 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; and
- 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, 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 in the last 3 months;
- Use of antibiotics in prior 30 days;
- Use of steroids, including corticosteroids, in prior 30 days;
- Allergies to study medications, such as, lidocaine, Versed, Fentanyl 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 the last 30 days. Subjects with a positive Tetrahydrocannabinol
(THC) strip test at any visit will be excluded;
- 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 (to minimize
confounding effects of another product) or intention to quit in next three months;
- BMI > 40 (risk of unstable airway)
- Pregnant or breastfeeding in prior 3 months - 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 before each bronchoscopy; and,
- Unable to read for comprehension or completion of study documents.
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
