A Pilot Study Evaluating Nicotine Lozenges and Self Help

Study Overview
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Brief Summary
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The investigators are hypothesizing that by offering both self-help materials and mailed nicotine lozenges we will be able to help increase tobacco abstinence rates among ST users, as well as decrease tobacco withdrawal.

Detailed Description
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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. Most smokeless tobacco users wish to quit. Assisted-self help interventions (i.e., self-help manual, a targeted video, and two support telephone phone calls) have been shown to be superior to manual-only interventions for increasing tobacco abstinence rates. These interventions lend themselves to widespread dissemination, but abstinence rates at 6 months remains low (21%). Providing nicotine replacement therapy (NRT) to ST users receiving assisted self-help interventions could improve upon these ST abstinence rates. If found to be effective, this intervention may increase the ability to disseminate effective interventions to a population of tobacco users for whom few treatment resources currently exist.

Official Title
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A Pilot Study to Assess the Effectiveness of the Nicotine Lozenge for Smokeless Tobacco Users

Conditions
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Smokeless Tobacco Use

Intervention / Treatment
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* Drug: nicotine replacement therapy
* Drug: placebo NRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male; ≥18 years of age; report ST as their primary tobacco of use; have used ST daily for the past 6 months; indicate that they want to quit; have been provided with, understand, and have signed the informed consent. Exclusion Criteria: previously enrolled in a study involving the use of the nicotine lozenge; currently using or have completed using (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 PSVT; 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; have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-9) on the phone call pre-screen.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active<br>Self-help counseling material and 4 mg nicotine lozenges | Drug: nicotine replacement therapy<br>* 4 mg nicotine lozenges, ad lib, for 12 weeks.<br>* Other names: Nicotine Lozenges;|
| Placebo Comparator: 2<br>self help counseling material and placebo nicotine lozenges | Drug: placebo NRT<br>* Placebo nicotine lozenges<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Tobacco Abstinence | self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco, chew, nrt, nicotine lozenges, self-help