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:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT03028558
Eligibility Criteria:
Inclusion Criteria:
* HEALTHY VOLUNTEER RESEARCH SUBJECTS:
Inclusion Criteria:
* Males and females, ages 21 to 35
* Must be capable of providing informed consent
* Self-reported never-smokers of any type, including chewing tobacco, with current smoking status validated by the absence of nicotine metabolites in urine (nicotine \<2 ng/ml and cotinine \<5 ng/ml)
* No bleeding diathesis
* Normal physical examination
* Good overall health without history of oral or lung disease
* Normal routine laboratory evaluation, including general hematologic studies, general serologic/immunologic studies, general biochemical analyses, and urine analysis
* Not taking any medications relevant to lung disease or having an effect on the airway epithelium
* Normal chest X-ray (PA and lateral)
* Normal electrocardiogram (sinus bradycardia, premature atrial contractions are permissible)
* Females - not pregnant
* Willingness to participate in the study
* HEALTHY VOLUNTEER E-CIGARETTE SMOKING SUBJECTS:
Inclusion Criteria:
* Males and females, ages 21 to 35
* Must be capable of providing informed consent
* E-cigarette smokers with current smoking status validated by nicotine metabolites in urine (nicotine \>20 ng/ml and cotinine \>30 ng/ml)
* No bleeding diathesis
* Normal routine laboratory evaluation, including general hematologic studies, general serologic/immunologic studies, general biochemical analyses, and urine analysis
* Good overall health without history of oral disease
* Normal spirometry
* All individuals have chest X-ray (PA and lateral)
* Normal electrocardiogram (sinus bradycardia, premature atrial contractions are permissible)
* Females - not pregnant
* Willingness to participate in the study
Exclusion Criteria:
* HEALTHY VOLUNTEER RESEARCH SUBJECTS:
Exclusion Criteria:
* Unable to meet the inclusion criteria
* Have smoked any form of tobacco
* Current marijuana smokers (within the last three months)
* Current active infection or acute illness of any kind
* Evidence of malignancy, including oral cancer
* Current pregnancy
* HEALTHY VOLUNTEER E-CIGARETTE SMOKING SUBJECTS:
Exclusion criteria:
* Unable to meet the inclusion criteria
* Have smoked any form of tobacco
* Current marijuana smokers (within the last three months)
* Current active infection or acute illness of any kind
* Evidence of malignancy, including oral cancer
* Current Pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
35 Years
Study:
NCT03028558
Study Brief:
Protocol Section:
NCT03028558