Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction

Study Overview
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Brief Summary
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Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Extant literature on cigarette smokers suggests that smoking reduction increases smoking abstinence among smokers not interested in quitting. The overarching goal of this line of research is to develop a ST reduction intervention among ST users not interested in quitting tobacco. Our first step is to conduct the proposed pilot study designed to assess the efficacy of the nicotine lozenges or tobacco-free snuff for reducing ST use or facilitating ST abstinence among ST users not interested in quitting.

Detailed Description
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In this study, we will enroll 81 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.

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

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Drug: nicotine lozenges
* Drug: tobacco-free snuff


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 18 years of age; no intention of quitting in the next one month; report ST as their primary tobacco of use; have used ST daily for the past 12 months; have been provided with, understand, and have signed the informed consent are able to complete all study visits; are in general good health as determined by medical history. Exclusion Criteria: currently using or have used (within the past 30 days) any other behavioral or pharmacologic tobacco treatment program; currently enrolled in another research study; 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; have phenylketonuria (PKU) [nicotine lozenges contain aspartame which is metabolized to phenylalanine and not processed in individuals with PKU]; have another member of their household already participating in this study; have other medical or psychiatric conditions that would exclude the participant in the opinion of the investigators; have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-8) on the phone call pre-screen; are currently pregnant are trying to become pregnant; are currently breast-feeding and unwilling to stop during this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nicotine lozenges<br>40 subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day. | Drug: nicotine lozenges<br>* 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day.<br>|
| Active Comparator: tobacco free snuff<br>41 subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed. | Drug: tobacco-free snuff<br>* Tobacco-free snuff used ad lib for a maximum of 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobacco Abstinence at 12 Weeks | Number of participants who were biochemically confirmed abstinent from tobacco at week 12 using urinary anabasine less than 2 ng per ml. | week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco dependence, tobacco reduction, chewing tobacco, snuff, moist snuff