In this study, we will enroll 80 subjects who will be randomized to either the nicotine lozenge or tobacco-free snuff to reduce their ST use over 8 weeks with follow-up at 12 weeks. Forty subjects will be recruited at Mayo Clinic in Rochester, MN, and 40 subjects will be recruited at the Oregon Research Institute in Eugene, Oregon.
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.
This study includes a screening period in which you will be informed of the study; if you decide to participate you will be asked to sign informed consent. Afterwards you will be asked to undergo a series of screening tests to see if you are eligible to participate in this study. The tests will include questions concerning your medical and tobacco history, a brief physical exam, and a pregnancy test using a urine sample.
If you are found to be eligible for study participation you will receive either the 4-mg nicotine lozenge or tobacco-free snuff. You will take the 4-mg nicotine lozenge or the tobacco-free snuff as needed for 8 weeks.
While on the study medication, you will be asked to return to the clinic for weekly clinic visits for the first 2 weeks (weeks 1-2), bi-weekly for weeks 2 to 8, a follow up visit at week 12 (visit 8) and a final study visit 9 (week 26).
26 weeks
Last updated: 07/10/2012
NCT ID: NCT01018394
IRB Number:09-005172
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