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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT01158456
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects with a smoking history of at least 10 cigarettes daily for at least 1 year;
2. Subjects report themselves, biological parents and both sets of biological grandparents as
* African American or African descent or
* European American or European descent
3. Subjects are in apparently good physical health (no unstable medical condition)
4. Subjects are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the PRIME-MD);
5. Subjects have provided written informed consent to participate in the study.
Exclusion Criteria:
1. Unstable medical conditions including cancer, coronary heart disease and arrhythmia
2. Cannot or unwilling to identify ethnic/racial ancestry
3. Women who are currently pregnant or breast feeding
4. Currently using any other tobacco or nicotine-containing product
5. Currently taking any medications that affect relevant metabolic enzymes.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT01158456
Study Brief:
Protocol Section:
NCT01158456