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

Phase 2/Phase 3
18 Years
Not Enrolling
Tobacco Dependence

Thank you

Trial Information

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

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

8. are currently pregnant are trying to become pregnant;

9. are currently breast-feeding and unwilling to stop during this study.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare the efficacy of nicotine lozenges and tobacco-free snuff for the reduction of ST use among ST users who have no intention of quitting tobacco.

Outcome Time Frame:

weeks 1,24,6,8,12

Safety Issue:


Principal Investigator

Jon O Ebbert, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

January 2009

Completion Date:

July 2012

Related Keywords:

  • Tobacco Dependence
  • tobacco dependence
  • tobacco reduction
  • chewing tobacco
  • snuff
  • moist snuff
  • Tobacco Use Disorder



Mayo ClinicRochester, Minnesota  55905
Oregon Research InstituteEugene, Oregon  97403