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 @ 12:54 PM
Ignite Modification Date:
2025-12-24 @ 12:54 PM
NCT ID:
NCT03153761
Eligibility Criteria:
Inclusion Criteria:
1. Able to read, understand, and willing to sign an Informed Consent Form (ICF) written in English;
2. Generally healthy males and females, 21 years of age or older, at Screening-Enrollment Visit;
3. Self-reports currently using at least two cans of moist snuff per week;
4. Self-reports that moist snuff is the only tobacco- or nicotine-containing product used within 30 days of the Screening-Enrollment Visit;
5. Usual brand (UB) of moist snuff is one of the products specified in the protocol;
6. Used their UB product for ≥ 3 months;
7. Subject is not delaying a decision to quit using moist snuff to participate in the study;
8. Agrees to exclusively use the study products and not use any other tobacco- or nicotine-containing products during the course of the study;
9. Able to safely perform the required study procedures, as determined by the Investigator.
Exclusion Criteria:
1. Self-reported history of heart disease, kidney disease, diabetes, liver disease, uncontrolled hypertension, or uncontrolled hypercholesterolemia;
2. At risk for heart disease, i.e., obesity (body mass index \[BMI\] \> 43 kg/m2), as determined by the Investigator;
3. Females ≥ 35 years of age currently using systemic, estrogen-containing contraception, or hormone replacement therapy;
4. Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (NRT) (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within 30 days prior to the Screening-Enrollment Visit;
5. Females who are pregnant or breastfeeding, or plan to become pregnant during the course of the study;
6. Participation in another clinical study within 30 days prior to the Screening-Enrollment Visit. (The 30-day window for each subject will be derived from the date of the last study event in the previous study to the Screening-Enrollment Visit of the current study);
7. Determined by the Investigator to be ineligible for the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03153761
Study Brief:
Protocol Section:
NCT03153761