Effects of E-cigs vs Pouches on Cigarette Smoking and Addiction
Evaluating The Effects Of E-cigarettes Versus Oral Nicotine Pouches and Product Constituents (Menthol Flavor, Nicotine Concentration) On Adult Cigarette Smoking and Addiction
Yale University
256 participants
Aug 20, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- + years old
- English literate
- Currently smoking cigarettes, biochemically confirmed
Exclusion Criteria4
- Currently using smoking cessation pharmacotherapies (NRT, bupropion, varenicline)
- Currently pregnant or breastfeeding
- Significant current medical or psychiatric condition
- Known hypersensitivity to propylene glycol
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06077240