Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation

Study Overview
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Brief Summary
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This research study will determine if using a combination of 4-mg nicotine lozenges, self-help materials, and/or telephone tobacco cessation counseling will help smokeless tobacco users stop using tobacco. The study will consist of three interventions: The Lozenge Assisted Self-help intervention - lozenge nicotine replacement therapy, phone counseling, and self help materials Assisted Self-Help intervention - self-help materials and phone counseling without lozenges Lozenge Self Help intervention - self help materials and lozenge nicotine replacement therapy. Hypothesis: The Lozenge Assisted Self-help intervention will significantly increase both the prolonged and point prevalence for all tobacco and smokeless tobacco (ST) abstinence rates at 6 months among ST users who are interested in achieving tobacco abstinence, compared to those in the Assisted Self-Help intervention and the Lozenge Self Help intervention.

Detailed Description
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The overarching aim of this line of research is to develop effective ST interventions that can be disseminated. In order to accomplish our aims, the investigators will enroll 1011 ST users in a multicenter, randomized controlled trial. The primary aims and hypotheses to be tested in this study are the following: To evaluate the effectiveness of a ST intervention combining the nicotine lozenge and assisted self-help (LASH) for increasing both prolonged and point prevalence all tobacco and ST abstinence rates at 6 months follow-up compared to an assisted self-help intervention (ASH)among ST users who are interested in achieving tobacco abstinence. Hypothesis: The LASH intervention - adding the lozenge as nicotine replacement therapy(NRT)- will significantly increase both the prolonged and point prevalence all tobacco and ST abstinence rates compared to the ASH intervention at 6 months among ST users who are interested in achieving tobacco abstinence. To evaluate the effectiveness of a ST intervention combining the nicotine lozenge and assisted self-help (LASH) for increasing both prolonged and point prevalence all tobacco and ST abstinence rates at 6 months follow-up compared to a lozenge plus self-help intervention (LSH group: no telephone counseling) among ST users who are interested in achieving tobacco abstinence. Hypothesis: The LASH intervention will significantly increase the point prevalence abstinence rates of all tobacco and ST at 6 months compared to the LSH intervention among ST users who are interested in achieving tobacco abstinence. Secondary aims to be tested in this study: To evaluate the incremental cost-per-quit of adding the nicotine lozenge to an assisted self-help intervention (or of adding an assisted self-help intervention to a nicotine lozenge intervention)for increasing tobacco abstinence rates. To evaluate changes in self-efficacy and other theoretically-relevant measures related to the use of the nicotine lozenge as potential mediators of tobacco abstinence. The investigators will also examine an exploratory aim: 1. The primary outcome for the exploratory aim is to compare the rate of nicotine metabolism with ST abstinence. Prior research with cigarette smokers shows that the Nicotine Metabolite Ratio (NMR) [i.e., ratio of trans-3'-hydroxycotinine to cotinine) is a predictor of smoking cessation success in particular that faster metabolizers treated with NRT or placebo had lower quit rates compared to slower metabolizers. The exploratory aim will test this association with Smokeless Tobacco users. The number of lozenges used is a data point to help inform this evaluation.

Official Title
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Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation

Conditions
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Smokeless Tobacco Cessation

Intervention / Treatment
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* Drug: Commit® nicotine lozenges (4 mg) & self-help materials
* Behavioral: Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials
* Behavioral: Phone counseling & self-help materials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or over Currently using smokeless tobacco products as primary tobacco product Use smokeless tobacco for the last 6 months Currently want to quit Able to read and write English; and Willing to share phone number, e-mail, and mailing address with the research project complete informed consent process Exclusion Criteria: have used behavioral or pharmacologic tobacco treatment in last 30 days medical history of unstable angina, myocardial infarction within the past 6 months, cardiac dysrhythmia other than medication-controlled atrial fibrillation or PSVT or medically treated or untreated hypertension with BP ≥ 180 systolic OR ≥ 100 diastolic have phenylketonuria (PKU) have another member of their household already participating in this study currently pregnant or nursing score of ≥ 15 on the Patient Health Questionnaire (PHQ-8)

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lozenge Self Help: self help materials & lozenge NRT.<br>Self-help materials + Commit® nicotine lozenges (4 mg) | Drug: Commit® nicotine lozenges (4 mg) & self-help materials<br>* Participants provided with instructions on standard use of lozenge for nicotine replacement therapy (NRT) & instructed to use the lozenge any time they have a craving or urge to use ST or tobacco. Dosing: weeks 1-6 one lozenge every 1-2 hours/16 per day, weeks 7-9 one lozenge every 2-4 hours/8 per day, weeks 10-12 one lozenge every 4-8 hours/4 per day + The Enough Snuff video and printed guide providing strategies for tobacco cessation.<br>* Other names: Lonzenge + self-help only;Behavioral: Phone counseling & self-help materials<br>* Three phone counseling sessions to assist in cessation from use of all tobacco + The Enough Snuff video and printed guide providing strategies for tobacco cessation.<br>* Other names: phone + self-help only;|
| Experimental: Lozenge Assisted Self-help: lozenge NRT, phone counseling, & self help materials<br>Self-help materials + Commit® nicotine lozenges (4 mg) + Phone counseling | Drug: Commit® nicotine lozenges (4 mg) & self-help materials<br>* Participants provided with instructions on standard use of lozenge for nicotine replacement therapy (NRT) & instructed to use the lozenge any time they have a craving or urge to use ST or tobacco. Dosing: weeks 1-6 one lozenge every 1-2 hours/16 per day, weeks 7-9 one lozenge every 2-4 hours/8 per day, weeks 10-12 one lozenge every 4-8 hours/4 per day + The Enough Snuff video and printed guide providing strategies for tobacco cessation.<br>* Other names: Lonzenge + self-help only;Behavioral: Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials<br>* Three phone counseling sessions to assist in cessation from use of all tobacco + lozenge nicotine replacement therapy (NRT) + The Enough Snuff video and printed guide providing strategies for tobacco cessation.<br>* Other names: lonzenge + phone + self-help;Behavioral: Phone counseling & self-help materials<br>* Three phone counseling sessions to assist in cessation from use of all tobacco + The Enough Snuff video and printed guide providing strategies for tobacco cessation.<br>* Other names: phone + self-help only;|
| Experimental: Assisted Self-Help: self-help materials & phone counseling without lozenges<br>Self-help materials + Phone counseling | Behavioral: Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials<br>* Three phone counseling sessions to assist in cessation from use of all tobacco + lozenge nicotine replacement therapy (NRT) + The Enough Snuff video and printed guide providing strategies for tobacco cessation.<br>* Other names: lonzenge + phone + self-help;Behavioral: Phone counseling & self-help materials<br>* Three phone counseling sessions to assist in cessation from use of all tobacco + The Enough Snuff video and printed guide providing strategies for tobacco cessation.<br>* Other names: phone + self-help only;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolonged All Tobacco Abstinence | The primary outcome measure will be self-reported prolonged abstinence from all tobacco use at 3- and 6-month follow-up. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Saliva Test for Bio-chemical Verification of Tobacco Abstinence | To verify self-report of prolonged abstinence, saliva will be collected once at 6 months. A salivary cotinine of < 15 ng/mL will be adjudicated as prolonged tobacco abstinence. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smokeless Tobacco Use