About this trial
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 criteria
Qualifiers
21+ years old
English literate
Currently smoking cigarettes, biochemically confirmed
Disqualifiers
Currently using smoking cessation pharmacotherapies (NRT, bupropion, varenicline)
Currently pregnant or breastfeeding
Significant current medical or psychiatric condition
Known hypersensitivity to propylene glycol
Trial design
Treatments tested in this trial
- 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
Treatment groups
Sponsors and collaborators
Yale University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator