Nicotine Dependence, Smoking, Smoking Behaviors
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALE-cigarette with 2.4% Nicotine with Menthol and Tobacco Flavors
Flavor availability is menthol and tobacco/unflavored with lower nicotine concentration.
BEHAVIORALE-cigarette with 2.4% Nicotine with Tobacco Flavor Only
Flavor availability is tobacco/unflavored only with lower nicotine concentration.
BEHAVIORALE-cigarette with 5% Nicotine with Menthol and Tobacco Flavors
Flavor availability is menthol and tobacco/unflavored with higher nicotine concentration.
BEHAVIORALE-cigarette with 5% Nicotine with Tobacco Flavor Only
Flavor availability is tobacco/unflavored only with higher nicotine concentration.
BEHAVIORALTobacco Pouches with 3mg Nicotine with Menthol and Tobacco Flavors
Flavor availability is menthol and tobacco/unflavored with lower nicotine concentration.
BEHAVIORALTobacco Pouches with 3mg Nicotine with Tobacco Flavor Only
Flavor availability is tobacco/unflavored only with lower nicotine concentration.
BEHAVIORALTobacco Pouches with 6mg Nicotine with Menthol and Tobacco Flavors
Flavor availability is menthol and tobacco/unflavored with higher nicotine concentration.
BEHAVIORALTobacco Pouches with 6mg Nicotine with Tobacco Flavor Only
Flavor availability is tobacco/unflavored only with higher nicotine concentration.
Sponsors
Yale University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
To avoid randomized non-starters and potential bias due to differential early attrition from prior knowledge of group assignment, randomization will occur at the time of visit 0 when participants first receive tobacco products specific to their assigned condition, and neither the research assistant nor participant will know the assignment in advance. Researchers and participants will be blinded to the nicotine concentration.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 21+ years old * English literate * Currently smoking cigarettes, biochemically confirmed
Exclusion criteria
* Currently using smoking cessation pharmacotherapies (NRT, bupropion, varenicline) * Currently pregnant or breastfeeding * Significant current medical or psychiatric condition * Known hypersensitivity to propylene glycol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aim 1: Average number of cigarettes smoked per day | From baseline to week 4 | 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. |
| Aim 2: Percent of days using non-combustible product | From baseline to week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aim 1: Percent of days abstinent from cigarettes | From baseline to week 4 | 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. |
| Aim 1: Biochemically verified 7 day point-prevalent abstinence from cigarettes | Week 4 | 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 |
| Aim 1: Cigarette Dependence | From baseline to week 4 | 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. |
| Aim 2: Average use of non-combustible products per day | From baseline to week 4 | 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. |
| Aim 2: Continued use of non-combustible products | Week 4 to 6 | 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. |
Countries
United States
Contacts
CONTACTLisa M. Fucito, PhD
CONTACTKrysten W Bold, PhD
PRINCIPAL_INVESTIGATORLisa Fucito, PhD
Yale University
PRINCIPAL_INVESTIGATORKrysten Bold, PhD
Yale University
Outcome results
None listed