Smoking Clinical Trial
Official title:
Evaluating The Effects Of E-cigarettes Versus Oral Nicotine Pouches and Product Constituents (Menthol Flavor, Nicotine Concentration) On Adult Cigarette Smoking and Addiction
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.
Status | Recruiting |
Enrollment | 256 |
Est. completion date | January 2029 |
Est. primary completion date | January 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - 21+ years old - English literate - Currently smoking cigarettes, biochemically confirmed - Not planning a smoking cessation attempt or to use smoking cessation pharmacotherapies (NRT, bupropion, varenicline) in the next month. Exclusion Criteria: - Currently using any smoking cessation services and/or pharmacotherapies - Currently pregnant or breastfeeding - Significant current medical or psychiatric condition - Known hypersensitivity to propylene glycol. |
Country | Name | City | State |
---|---|---|---|
United States | Yale University | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Aim 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. | From baseline to week 4 | |
Primary | 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. | From baseline to week 4 | |
Secondary | 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. | From baseline to week 4 | |
Secondary | 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 | Week 4 | |
Secondary | Aim 1: Cigarette Dependence | Cigarette dependence will be measured using the 4-item PROMISĀ® 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. | From baseline to week 4 | |
Secondary | 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. | From baseline to week 4 | |
Secondary | 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. | Week 4 to 6 |
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