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 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT05468333
Eligibility Criteria:
Inclusion Criteria:
* Daily cigarette smoker of 5+ cigarettes/day for at least the past 6 months and consumed 100+ lifetime cigarettes
* Smoke non-menthol, filtered cigarettes
* Report daily use of any non-Natural American Spirit (NAS) cigarette brand for the last 30 days (for the non-NAS smoker group), or report daily use of NAS cigarettes for at least 30 days (for the NAS smoker group)
* Provide exhaled CO level \>= 10 ppm at the Session 1 visit
* Able to communicate fluently in English (speaking, writing, and reading)
* Capable of providing written informed consent, which includes compliance with the requirements and restrictions listed in human participant protections
Exclusion Criteria:
* Current use of Nat's cigarettes as a preferred brand
* Plan to quit smoking in the next 30 days and not currently undergoing smoking cessation treatment
* Are pregnant, planning a pregnancy, and/or lactating
* Have any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing the completion of procedures included within this protocol
* Have had a serious or unstable disease within the past 6 months (e.g. heart disease, cancer, schizophrenia).
* Cannot have ever regularly smoked NAS (for the non-NAS group)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT05468333
Study Brief:
Protocol Section:
NCT05468333