Using Smokeless Tobacco Products With Lower Nicotine Levels to Reduce Negative Effects of Smokeless Tobacco Use

Study Overview
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Brief Summary
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Though spit tobacco is smokeless, it still affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. This study will assess the effectiveness of limiting smokeless tobacco (ST) nicotine intake in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake.

Detailed Description
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Spit tobacco presents as many health risks to its users as smoking tobacco. It affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. Long-term effects of spit tobacco use include tooth abrasion, gum recession, mouth disease, bone loss in the jaw, yellowing of the teeth, and chronic bad breath. Although a significant number of ST users recognize the importance of quitting, many either do not want to quit or feel it is impossible. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting, or as a treatment endpoint; however, approaches to help ST users reach this goal have not been studied. This study will assess the effectiveness of limiting ST nicotine intake in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake. Participants in this open-label study will be randomly assigned to one of three treatment conditions: switching to an ST brand with less concentrated nicotine and controlling for ST use; switching to an ST brand with less concentrated nicotine, combined with no limit on ST intake; or continued use of usual ST brand with no limit on intake (control group). Participants in both brand-switching conditions will use ST brands that have 50% less nicotine than their usual ST brands for the first 4 weeks. For the next 4 weeks, participants in the brand-switching conditions will use ST brands that have 75% less nicotine that their usual ST brands. Study visits will ocur once weekly during the 8-week treatment period. The number of participants who do not complete treatment, reduce nicotine intake, or quit completely will be assessed at Week 8 and at follow-up visits, which will be held 12 and 26 weeks following the completion of treatment.

Official Title
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Treatment of Smokeless Tobacco Users: Use of Nicotine Replacement Products to Reduce Smokeless Tobacco Use

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Other: Lower Nicotine Smokeless Tobacco Product
* Other: Behavioral Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Not interested in quitting ST use within 90 days of study entry Has been using ST at least six times a day for 6 months prior to study entry Agrees to use an effective form of contraception throughout the study Exclusion Criteria: Current use of other tobacco or nicotine products Pregnant or breastfeeding Any unstable medical condition Use of any medication that may affect tobacco use or be affected by reduction of tobacco use DSM-IV diagnosis of any psychiatric disorders or substance abuse disorders within 6 months prior to study entry Use of any psychotropic medications within 6 months prior to study entry

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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No

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: 1 Controlled use<br>Reduction in tobacco toxicants by switching to a lower nicotine tobacco product under a controlled use condition. | Other: Lower Nicotine Smokeless Tobacco Product<br>* Skoal for 50% reduction;Skoal bandits for 75% reduction.<br>* Other names: Skoal and Skoal Bandits;|
| Active Comparator: 2 Uncontrolled use<br>Reduction in tobacco toxicants by switching to a lower nicotine tobacco product under an uncontrolled use condition. | Other: Lower Nicotine Smokeless Tobacco Product<br>* Skoal for 50% reduction;Skoal bandits for 75% reduction.<br>* Other names: Skoal and Skoal Bandits;|
| Placebo Comparator: 3 Behavioral<br>Reduction in smokeless tobacco use using behavioral techniques only. | Other: Behavioral Counseling<br>* Behavioral counseling alone for reduction in tobacco use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction in ST use |  | 26 weeks | 
| Toxicity profile of carcinogen metabolites |  | 26 weeks | 
| Number of unsuccessful quit attempts |  | 26 weeks | 
| Abstinence from ST use (measured at Week 8, and 12 and 26 weeks following treatment completion) |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motivation and self-efficacy (measured at Week 8, and 12 and 26 weeks following treatment completion) |  | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brand Switching, smokeless tobacco use