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
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.
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.
Eligibility
- Age range
- 21+ years
- Sex
- All
- 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
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.
Location
- Yale UniversityNew Haven, Connecticut