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 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT04090606
Eligibility Criteria:
Inclusion Criteria:
* Male or female adult smokers 18-65 years of age, who smoke at least 7 cigarettes per day (to assure that biomarker levels are above the limit of quantitation) and do not have plans to quit smoking in the next month;
* Smoked the same brand for \>80% of their cigarettes over the course of at least 1 year, and smoked not more than 20 cigarettes (1 pack) of a different brand within two weeks prior to the eligibility screening;
* Not using any other nicotine or tobacco product;
* Subjects who are not taking any medications that affect relevant metabolic enzymes;
* Women who are not pregnant or nursing;
* Subjects have provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves use of tobacco products).
Exclusion Criteria:
* Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data;
* Current or recent alcohol or drug abuse problems (to ensure alcohol and drug use does not affect biomarkers of exposure and to maximize retention);
* Regular tobacco use (e.g., greater than weekly) other than cigarettes;
* Currently using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product);
* Pregnant or breastfeeding (due to toxic effects from tobacco products)
* Report smoking more than 1 pack (20 cigarettes) of a non-usual brand cigarette in the past two weeks \* Participants who report smoking 2 or more non-usual brand cigarettes the day before the clinic visit will be ineligible
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04090606
Study Brief:
Protocol Section:
NCT04090606