Highdose Nicotine Patch Therapy for Smokeless Tobacco Use

Study Overview
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Brief Summary
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Smokeless tobacco use (chewing) is associated with negative health effects. To date, no medications have been shown to help chewers quit long-term. High dose nicotine patch therapy may improve the chances that chewers can quit for good. If found to be effective, chewers may use this treatment to help them quit and reduce their risk for negative health effects.

Detailed Description
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Approximately 8.2 million (3.3%) of Americans ≥ 12 years of age are current smokeless tobacco (ST) users, and the prevalence of ST use has increased over the past three years. ST is increasingly being promoted as a harm reduction strategy for cigarette smoking, and two of the world's largest cigarette manufacturers have entered the ST market. ST use is estimated to be the greatest exogenous source of human exposure to cancer-causing nitrosamines. ST has been associated with oral and extra-oral cancer as well as cardiovascular and cerebrovascular mortality. A need for efficacious interventions exists as 64% of ST users report the desire to quit. However, no pharmacotherapy has proven efficacy for increasing long-term (> 6 months) tobacco abstinence rates among ST users compared to placebo. New pharmacotherapies, drug combinations, and improved dosing of existing pharmacotherapies are needed. Previous research with nicotine patches for ST users using standard doses (up to 21 mg/day) have not increased long-term abstinence rates. However, studies of higher dose nicotine patch therapy (up to 63 mg/day) in ST users have demonstrated a dose-dependent reduction in tobacco withdrawal symptoms as well as preliminary evidence of increased long-term (> 6 months) abstinence rates compared to lower doses. The purpose of this study is to evaluate the efficacy of high dose nicotine patch therapy (42 mg/day) for increasing the 7-day point prevalence and prolonged all tobacco and ST abstinence rates at end-of-treatment (week 8), 12 and 24 weeks compared to placebo in ST users who use ≥ 3 cans/pouches per week when all subjects receive behavioral treatment for tobacco dependence. To accomplish our aims, we will randomize 60 ST users in a clinical pilot study. The work will be conducted at the Mayo Clinic in Rochester, MN.

Official Title
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Highdose Nicotine Patch Therapy for Smokeless Tobacco Use

Conditions
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Smokeless Tobacco Use

Intervention / Treatment
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* Drug: nicotine replacement therapy (nicotine patches)
* Drug: placebo NRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are at least 18 years of age and at most 55 years of age; report daily ST use for the past 12 months; identify ST as their primary tobacco product; use an average of ≥ 3 cans/pouches per week; are in general good health (determined by medical history and screening physical examination); have been provided with, understand, and have signed the informed consent. Exclusion Criteria: are currently using (past 30 days) any other behavioral or pharmacologic tobacco treatment program; are currently pregnant or lactating; have had unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months; have a history of arrhythmia or an abnormal tracing on the baseline EKG; have a blood pressure of greater than 140/90 or a pulse of more than 110 beats per minute; have a history of severe skin allergies or dermatoses; have a history of intolerance to nicotine patches; have another member of their household already participating in this study; are taking a medication known to interact with nicotine (i.e., clozapine); are taking any prescription medication for depression or asthma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks | Drug: nicotine replacement therapy (nicotine patches)<br>* 2- 21 mg patches per day for 8 weeks<br>|
| Placebo Comparator: placebo<br>2 patches (containing non active ingredients) per day for 8 weeks | Drug: placebo NRT<br>* 2 placebo patches (containing no active ingredient)per day for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End of Treatment (Week 8) Point Prevalence Abstinence | 7 day point prevalence abstinence at the end of treatment, biochemically confirmed by urinary anabasine < 2 ng per ml | weeks 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point-prevalence Abstinence at 3 Months | 7 day point prevalence abstinence from tobacco at 3 months, biochemically confirmed using urinary anabasine < 2 ng per ml | week 12 | 
| Point-prevalence Abstinence at 6 Months | 7 day point prevalence abstinence from all tobacco at 6 months, biochemically confirmed using urinary anabasine < 2 ng per ml. | week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco use, smokeless tobacco, chewing tobacco, snuff, nicotine replacement, tobacco dependence, tobacco cessation, tobacco abstinence