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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT05960305
Eligibility Criteria:
Inclusion Criteria:
* 1\. Generally healthy adult males or females, 21-60 years old, inclusive, verified with government-issued photo ID.
2\. Must be a current smoker of manufactured menthol and/or non-menthol cigarettes, has smoked at least 100 cigarettes in their lifetime, and smoked 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 (in the past 30 days).
4\. Must indicate "an intention to use" (6 or higher on a 10-point Likert scale) for at least one Study IP flavor per arm across all three study arms after a brief review of the products and related information (i.e. User Guide and Handout MM) at the SEV.
5\. Has not participated in any tobacco-, ENDS-, or nicotine-related research within 1 month of screening.
6\. Must sign the Informed Consent Forms (ICFs) and thereby agree to participate in the 8-week study, comply with all study requirements, including eDiary reporting procedures and completion of questionnaires/eDiary in English, and agree that the Study IP received are for their own personal use and will not be shared with others.
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 prior to pre-screening).
2\. Currently a regular ENDS user (using ENDS \>3 days per week, in the past 30 days), based on self-report.
3\. Female subjects who are pregnant or breastfeeding or planning to become pregnant or start breastfeeding within the next 6 months based on self-report.
4\. Female subjects who state they are not using adequate methods to prevent pregnancy.
5\. Female subjects (as assigned at birth) who do not have a definitive negative pregnancy test result at SEV.
6\. Self-reports "poor" physical health
7\. Self-reports "poor" mental health
8\. Employees of a company that manufactures tobacco or ENDS products.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT05960305
Study Brief:
Protocol Section:
NCT05960305