Effects of E-cigs vs Pouches on Cigarette Smoking and Addiction
Start Date
8/20/2024
Completion Date
4/1/2028
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.
Eligibility Criteria
Age Range: 21 years to No maximum
Interventions
E-cigarette with 2.4% Nicotine with Menthol and Tobacco Flavors
E-cigarette with 2.4% Nicotine with Tobacco Flavor Only
E-cigarette with 5% Nicotine with Menthol and Tobacco Flavors
E-cigarette with 5% Nicotine with Tobacco Flavor Only
Tobacco Pouches with 3mg Nicotine with Menthol and Tobacco Flavors
Tobacco Pouches with 3mg Nicotine with Tobacco Flavor Only
Tobacco Pouches with 6mg Nicotine with Menthol and Tobacco Flavors
Tobacco Pouches with 6mg Nicotine with Tobacco Flavor Only
Conditions
Locations
Yale University
New Haven, Connecticut 06520
United States