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 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT00888459
Eligibility Criteria:
Inclusion Criteria:
1. male;
2. ≥18 years of age;
3. report ST as their primary tobacco of use;
4. have used ST daily for the past 6 months;
5. indicate that they want to quit;
6. have been provided with, understand, and have signed the informed consent.
Exclusion Criteria:
1. previously enrolled in a study involving the use of the nicotine lozenge;
2. currently using or have completed using (past 30 days) any other behavioral or pharmacologic tobacco treatment program;
3. currently enrolled in another research study;
4. 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 PSVT; or d) medically-treated or untreated hypertension with BP ≥ 180 systolic OR ≥ 100 diastolic;
5. have phenylketonuria (PKU) \[nicotine lozenges contain aspartame which is metabolized to phenylalanine and not processed in individuals with PKU\];
6. have another member of their household already participating in this study;
7. have other medical or psychiatric conditions that would exclude the participant;
8. have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-9) on the phone call pre-screen.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00888459
Study Brief:
Protocol Section:
NCT00888459