Comparison Across Treatment Conditions to Reduce Smokeless Tobacco Use

Study Overview
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Brief Summary
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Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has health risks associated with its use. While treatment programs that focus on stopping tobacco use may be effective, past research has shown that interventions that specifically focus on reducing tobacco use may be equally effective and may motivate individuals to eventually quit using tobacco. This study will compare the effectiveness of a ST reduction treatment program versus a usual tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users.

Detailed Description
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Individuals who use ST are at increased risk for cancer or dying from cardiovascular disease. Other long-term effects include tooth abrasion, gum recession, and loss of bone in the jaw. Many individuals who use ST recognize the health risks associated with ST, but either do not want to quit or feel that it is impossible to quit. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting or as a treatment endpoint. By participating in a tobacco reduction program, these individuals may be motivated to eventually stop using tobacco altogether. The purpose of this study is to compare a ST reduction treatment program versus a standard tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users. This study will enroll regular users of ST. Participants will be randomly assigned to either a tobacco reduction program or to usual care, a standard tobacco cessation program during the first telephone contact. At the first clinic visit, participants assigned to the tobacco Reduction Group will replace their usual brand of ST with one of two options: an ST brand with less nicotine or nicotine lozenge. Participants will be encouraged to reduce their nicotine intake by at least 50% the first two weeks and encouraged to further reduce their nicotine intake in the following 4 weeks. Participants assigned to the Usual Care Group will be advised to quit and will be asked to set a quit date within two weeks. Telephone counseling, ideas on methods for sustaining cessation, and a self-help manual will also be provided along with a 2 week supply of nicotine patches. Study visits will occur at 2, 4, 8, 12, 26, and 32 (for reduction group) weeks. Outcome assessments will include vital signs, physiological measures related to tobacco use, levels of nicotine reduction, tobacco use status, and measures of motivation and self-efficacy to quit.

Official Title
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Treatment of Smokeless Tobacco Users

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Drug: Usual Care Group
* Other: Reduction Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No interest in stopping ST use within 90 days of study entry Daily use of ST in the 6 months prior to study entry Exclusion Criteria: Current use of tobacco or nicotine products, other than ST Current unstable medical and mental health conditions Use of any medication that may affect tobacco use or be affected by a reduction in tobacco use Pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Usual Care Group<br>Usual care for cessation with immediate quit date scheduled and two weeks of nicotine patch supplied. | Drug: Usual Care Group<br>* Nicotine replacement therapy<br>* Other names: Nicoderm;|
| Experimental: Reduction Group<br>Reduction in nicotine exposure for 6 weeks prior to quit date using medicinal nicotine lozenge or reduced nicotine smokeless tobacco. | Other: Reduction Group<br>* Subject selects preferred method for reduction.<br>* Other names: Reduced nicotine smokeless tobacco products (Skoal, Skoal Bandits);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence) | No tobacco use 7 days prior to Week 12 verified by biomarkers (urine, cotinine and CO) | 12 weeks | 
| Percent Prolonged Abstinence From Tobacco at Week 12 | Continuous tobacco cessation from quit date through Week 12 verified by biomarkers (urine, cotinine and CO) | 12 weeks | 
| Percent Abstinent From Tobacco at Week 26 (7 Day Point Prevalence) | Abstinence from tobacco 7 days prior to Week 26 (Assessed at 26 weeks for Usual Care and 20 weeks for Reduction Group post-quit date) | 26 week | 
| Percent Prolonged Abstinence From Tobacco at Week 26 | Continuous Abstinence from quit date through Week 26 (Assessed at Week 26 for Usual Care and Week 20 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care). | 26 weeks | 
| Percent Abstinent From Tobacco at Week 32 (7 Day Point Prevalence) | Abstinence from tobacco 7 days prior to Week 26 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group. Reduction Group's quit date is 6 weeks later than Usual Care). | 32 Weeks | 
| Percent Prolonged Abstinence From Tobacco at Week 32 | Continuous Abstinence from quit date through Week 32 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care). | 32 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicotine Dependence, Tobacco Dependence