A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco

Study Overview
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Brief Summary
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This nationwide telephone and mail- based research study will recruit 1,400 cigarette smokers who are not motivated to quit to test the effects of a marketed oral, non-combustible smokeless tobacco product on cigarette smoking behaviors. It will also track the participants' usage patterns of the smokeless tobacco product. Half of the participants will receive a new, potentially safer tobacco product during the first six weeks of the study, and half will not. During this six-week period, each participant will complete three brief phone interviews. After this first six week period, participants will complete 6 other brief follow-up interviews, where they will answer questionnaires about their smoking habits.

Official Title
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A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco

Conditions
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Smoking, Smoking Cessation

Intervention / Treatment
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* Drug: Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >=19 a daily cigarette smoker of >=10 cigs/day English speaking live in the contiguous U.S. unmotivated to quit smoking in the next 30 days Exclusion Criteria: no use of smokeless tobacco in past six months not breastfeeding, pregnant, or planning a pregnancy devoid of any recent (past 6 months) cardiovascular trauma no quit attempt of >=1 week in past 6 months no use of pharmacotherapy to quit smoking in past 3 months

Ages Eligible for Study
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Minimum Age: 19 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PREP (Potentially Reduced Exposure Product) Group<br> | Drug: Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product<br>* The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.<br>|
| No Intervention: cigarette group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quit Attempts and Abstinence | % of study participants making a quit attempt or staying abstinent from smoking during the study Notes: Floating abstinence: Any 7-day period of non-smoking, ever within study. PPA: point-prevalence abstinence | From study enrollment through end of one-year follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, smoking cessation, Potentially Reduced Exposure Products (PREPs)