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:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT03943706
Eligibility Criteria:
Inclusion Criteria:
* be at least 18 years old
* live within 30 miles of the research site
* interested in/willing to use an e-cigarette during study visits
* be willing and able to complete study procedures including specimen collection, survey completion, and remaining nicotine abstinent for 12 hours prior to each study visit
* speak and understand English
* willing to provide informed consent
* bring usual brand cigarettes to screener study visit.
Additional Inclusion criteria for smokers:
* smoke at least 10 cigarettes per day for the past three months,
* exhaled more than equal to 6 ppm carbon monoxide at the screener visit.
Additional Inclusion criteria for dual users:
* smoke more than equal to 5 tobacco cigarettes per day for the last 3 months,
* use e-cigarettes at least 15 days per month for the last 3 months, and
* bring e-cigarette device to screener study visit.
Exclusion Criteria:
* currently suffering from lung disease including asthma, cystic fibrosis (CF), or chronic obstructive pulmonary disease (COPD), unless it is well-controlled,
* currently pregnant or breast-feeding or have plans to become pregnant or begin breast-feeding at any point during the study,
* intoxicated at study visits (breath alcohol testing and clean urine drug screen),
* any known allergies or sensitivity to the known major constituents contained in the aerosol of the study e-cigarette devices (e.g., flavorants, vegetable glycerin, propylene glycol),
* User of zero-nicotine e-cigarettes,
* smokes mentholated cigarettes regularly,
* history of cardiac event or distress within the past 3 months.
Additional Exclusion criteria for smokers:
* have previously used any e-cigarette device (cig-a-like, pen style, mod, APV) for longer than 30 days
* use of an e-cigarette device over the past 14 days.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03943706
Study Brief:
Protocol Section:
NCT03943706