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 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT01018394
Eligibility Criteria:
Inclusion Criteria:
1. at least 18 years of age;
2. no intention of quitting in the next one month;
3. report ST as their primary tobacco of use;
4. have used ST daily for the past 12 months;
5. have been provided with, understand, and have signed the informed consent
6. are able to complete all study visits;
7. are in general good health as determined by medical history.
Exclusion Criteria:
1. currently using or have used (within the past 30 days) any other behavioral or pharmacologic tobacco treatment program;
2. currently enrolled in another research study;
3. describe having a medical history of: (a) unstable angina; (b) myocardial infarction within the past 6 months; (c) cardiac dysrhythmia other than medication-controlled atrial fibrillation or paroxysmal supraventricular tachycardia; or (d) medically-treated or untreated hypertension with BP ≥ 180 systolic OR ≥ 100 diastolic;
4. have phenylketonuria (PKU) \[nicotine lozenges contain aspartame which is metabolized to phenylalanine and not processed in individuals with PKU\];
5. have another member of their household already participating in this study;
6. have other medical or psychiatric conditions that would exclude the participant in the opinion of the investigators;
7. have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-8) on the phone call pre-screen;
8. are currently pregnant are trying to become pregnant;
9. are currently breast-feeding and unwilling to stop during this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01018394
Study Brief:
Protocol Section:
NCT01018394