The study will recruit an anticipated 256 adults who currently smoke cigarettes and report a willingness to try switching to alternative, non-combustible products. Participants will be randomized to receive either e-cigarettes or nicotine pouches for a duration of 4 weeks and to 1 of 4 possible regulatory scenarios within products where flavor availability is either menthol and tobacco/unflavored available or tobacco/unflavored only available, and nicotine concentration is either higher (5% e-cig, 6mg pouch) or lower (2.4% e-cig, 3mg pouch). Participants will return for bi-weekly research visits (in person or remote videocall) to complete measures for study aims. Participants will complete a final follow-up at Week 6 to assess maintenance of cigarette reduction and willingness to continue using products once they are no longer provided. The investigators expect to observe which products and constituents lead to greater smoking reduction.
The study includes 5 visit and assessments over 6 weeks. The intake visit will take approximately 60 minutes and subsequent visits will take approximately 30 minutes. The study is proposed to run for 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
256
Flavor availability is menthol and tobacco/unflavored with lower nicotine concentration.
Flavor availability is tobacco/unflavored only with lower nicotine concentration.
Flavor availability is menthol and tobacco/unflavored with higher nicotine concentration.
Flavor availability is tobacco/unflavored only with higher nicotine concentration.
Flavor availability is menthol and tobacco/unflavored with lower nicotine concentration.
Flavor availability is tobacco/unflavored only with lower nicotine concentration.
Flavor availability is menthol and tobacco/unflavored with higher nicotine concentration.
Flavor availability is tobacco/unflavored only with higher nicotine concentration.
Yale University
New Haven, Connecticut, United States
RECRUITINGAim 1: Average number of cigarettes smoked per day
Participants will report the total number of cigarettes consumed each day using a well-validated timeline follow-back (TLFB) interview method to assess number of cigarettes smoked per day continuously over the 4-week observational period for each product condition.
Time frame: From baseline to week 4
Aim 2: Percent of days using non-combustible product
Participants will report daily use of e-cigarettes or nicotine pouches using a well-validated timeline follow-back (TLFB) interview method continuously over the 4-week observational period to determine the total percent days use of the non-combustible product for each product condition.
Time frame: From baseline to week 4
Aim 1: Percent of days abstinent from cigarettes
Participants will report the total number of cigarettes consumed each day using a well-validated timeline follow-back (TLFB) interview method to assess number of cigarettes smoked per day continuously over the 4-week observational period to determine the total percent days abstinent (smoke-free) for each product condition.
Time frame: From baseline to week 4
Aim 1: Biochemically verified 7 day point-prevalent abstinence from cigarettes
Complete switching from cigarettes will be assessed at the end of the study period using self-reported TLFB methods and biochemical verification with expired breath carbon monoxide (CO) testing (CO \< 5ppm) to determine rates of 7-day point-prevalent abstinence
Time frame: Week 4
Aim 1: Cigarette Dependence
Cigarette dependence will be measured using the 4-item PROMIS® Short Form v1.0 - Smoking Nicotine Dependence for All Smokers 4a. Each item is scored from 1-5 with the range of scores from 4-20 with higher scores representing greater cigarette dependence.
Time frame: From baseline to week 4
Aim 2: Average use of non-combustible products per day
Participants will report daily e-cigarette and nicotine pouch quantity and frequency consumed using a well-validated timeline follow-back (TLFB) interview method to use continuously over the 4-week observational period for each product condition.
Time frame: From baseline to week 4
Aim 2: Continued use of non-combustible products
Participants will report daily use of e-cigarettes or nicotine pouches using a well-validated timeline follow-back (TLFB) interview method to determine the total percent days use of the non-combustible product for each product condition during the follow-up period.
Time frame: Week 4 to 6
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