A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco
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|ClinicalTrials.gov Identifier: NCT01509586|
Recruitment Status : Completed
First Posted : January 13, 2012
Results First Posted : August 1, 2016
Last Update Posted : August 1, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Smoking Smoking Cessation||Drug: Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1236 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
|Experimental: PREP (Potentially Reduced Exposure Product) Group||
Drug: Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product
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.
|No Intervention: cigarette group|
- Quit Attempts and Abstinence [ Time Frame: From study enrollment through end of one-year follow up ]
% of study participants making a quit attempt or staying abstinent from smoking during the study
Floating abstinence: Any 7-day period of non-smoking, ever within study. PPA: point-prevalence abstinence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509586
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Matthew J. Carpenter, Ph.D.||Medical University of South Carolina|