A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco
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.
|Smoking Smoking Cessation||Drug: Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco|
- 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
|Study Start Date:||November 2011|
|Study Completion Date:||March 2016|
|Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
|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|
Please refer to this study by its ClinicalTrials.gov identifier: 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|