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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT05030194
Eligibility Criteria:
Inclusion Criteria:
* Current daily cigarette smoker as determined by:
1. Smokes \>5 cigarettes/day for \>1 year OR
2. Current daily smokeless tobacco or oral nicotine user as determined by:
a. Uses \>=5 units/day for \>=1 year
* b. Uses portioned moist snuff, loose moist snuff and/or nicotine patches
* Willingness to abstain from using cigarettes/ST (smokeless tobacco) for 8-10 hours (overnight abstinence) prior to study visits (verified by exhaled-air carbon monoxide \< 10ppm).
* Self-report fair or better physical health.
* Self-report fair or better mental health.
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related products
Exclusion Criteria:
* Currently uses other tobacco or nicotine products (e.g., ENDS) \> 2 days/week.
* Self-report having active, untreated medical/psychiatric conditions History of serious side effects from nicotine or from any nicotine replacement therapies.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Nursing female participants.
* Vulnerable populations, such as cognitively impaired adults, individuals who are not yet adults, pregnant women, and prisoners.
* Unwilling or unable to follow protocol requirements.
* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug.
* Previous use of the study products (ZYN or Vuse Alto; on! or General Slims).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
55 Years
Study:
NCT05030194
Study Brief:
Protocol Section:
NCT05030194