Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT03691350
Eligibility Criteria:
Inclusion Criteria:
* Smokers who smoke \>= 5 filtered cigarettes/day for \>= 1 year
* No unstable or 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:
* Regular consumption of roll your own cigarettes
* Immune system disorders requiring medication
* Prior diagnosis of chronic pulmonary disease (e.g., asthma with regular use of medications, chronic obstructive pulmonary disease \[COPD\], chronic bronchitis, and restrictive lung disease)
* Acute bronchitis or pneumonia within 1 year
* Reported history of diagnosed kidney or liver disease
* Any medical disorder that will increase the risk from bronchoscopy, affect biomarker data, or increase risk of an adverse effect from e-cig use
* General anesthesia within 1 year
* Regular use of inhalant medications in the last 2 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
* Allergies to propylene glycol/glycerin or flavors
* History of hypersensitivity to varenicline
* Bronchoscopy or any other lung procedure for any reason within the previous 6 months
* Current or recent (within three months) alcohol or drug abuse problems
* Regularly smoked marijuana within the prior 3 months
* Use of an e-cigarette or other combustible tobacco products in the prior 3 months
* Currently using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product) or intention to quit in next three months
* Adverse reaction to previous e-cig use
* Body mass index (BMI) \> 40 (risk of unstable airway)
* Pregnant or breastfeeding - if the subject is female, a urine pregnancy test at no cost to the subject will be done on the day of bronchoscopy
* Unable to read for comprehension or completion of study documents
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
52 Years
Study:
NCT03691350
Study Brief:
Protocol Section:
NCT03691350