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 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT05184920
Eligibility Criteria:
Inclusion Criteria:
1. Adult males or females, 21-60 years old, inclusive, verified with government-issued photo ID.
2. Must be a current smoker of factory-made filtered menthol and/or non-menthol cigarettes, has smoked at least 100 cigarettes in their lifetime, and typically smokes on at least 20 days out of the past 30 days.
3. Smokes on average ≥ 5 combustible cigarettes per day (CPD) on days when cigarettes are smoked. (There are no other requirements or exclusions regarding other TNP use. Dual and poly-users may enroll if they fulfill the cigarette use requirements.)
4. Must indicate "an intention to use" Study IP after a brief review of product information and product demonstration at the SEV. Subjects will not try the product at the SEV.
5. Available and interested in participating in an 8-week study about the Study IP.
6. Able and willing to comply with all study requirements, including questionnaires, the eDiary reporting procedures, and provide valid contact information.
7. Able to read, understand, and willing to sign Informed Consent Forms (ICFs) and complete questionnaires written in English.
8. Has not participated in any tobacco-, vapor-, or nicotine-related research within 3 months of screening.
9. Agrees that the IP received are for their own personal use and they will not share the product with others.
10. Agrees to restrict use of Study IP to only the investigational products (specified flavors, nicotine levels, and pouch sizes) supplied by the study Sponsor free of charge and labeled as "For Investigational Use Only" and to not obtain/use any other nicotine pouch products from other commercial sources.
Exclusion Criteria:
1. Self-reports as currently quitting or intending to quit within the next 3 months all tobacco or nicotine product use ("currently" is defined as within (≤) 30 days). Those who intend to quit CC only can be enrolled.
2. Must not be an ever-user of any nicotine pouches prior to screening.
3. Female subjects who are currently pregnant or breastfeeding or planning to become pregnant or start breastfeeding within the next 6 months based on self-report.
4. Female subjects who self-report they are not using adequate methods to prevent pregnancy.
5. Self-reports "poor" physical health (based on the five-category Population Assessment of Tobacco and Health (PATH) questionnaire): "In general, how would you rate your physical health?" (Response choices: Excellent, Very Good, Good, Fair, Poor).
6. Self-reports "poor" mental health (based on the five-category PATH questionnaire): "In general, how would you rate your mental health?" (Response choices: Excellent, Very Good, Good, Fair, Poor).
7. Employees of tobacco or vapor companies.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT05184920
Study Brief:
Protocol Section:
NCT05184920