A Pilot Study to Compare the Nicotine Lozenge and Tobacco-Free Snuff for Smokeless Tobacco Reduction

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 PSVT; 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.