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 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT03998735
Eligibility Criteria:
Inclusion Criteria:
* Male or female adult smokeless tobacco users 18-65 years of age, using at least 3 tins of product per week for 6 months;
* Used the same brand for \>80% of their smokeless tobacco use over the course of at least 6 months, and used this brand exclusively for at least two weeks prior to the eligibility screening;
* Not smoking or using any other nicotine or tobacco product in the past 2 weeks (expired CO \< 6 ppm);
* Participants are in good physical health (no unstable medical condition) and good general oral health as determined by the licensed medical professional;
* Participants 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 licensed medical professional;
* Participants who are not taking any medications that affect relevant metabolic enzymes;
* Women who are not pregnant or nursing or planning to become pregnant;
* Participants have provided written informed consent to participate in the study.
Exclusion Criteria:
* Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data as determined by the licensed medical professional;
* Vital signs out of range as determined by the licensed medical professional (participants failing for vital signs will be allowed to re-screen once):
* Evident poor oral health (significant gum recession, dental caries, tooth loss) as determined by the general oral health status check;
* Excessive drinking (e.g., 5 or more drinks daily) or problems with drinking or drugs (e.g., self-report of binge drinking alcohol or treatment for drug or alcohol abuse within last 3 months); to be assessed by PI or licensed medical professional;
* Regular smoking or tobacco use (e.g., greater than once a week) other than oral smokeless tobacco products;
* Currently (within the past 2 weeks) using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product);
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03998735
Study Brief:
Protocol Section:
NCT03998735