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Effects of E-cigs vs Pouches on Cigarette Smoking and Addiction

RecruitingNAAges 21 Years - anyAllYale University
NCT06077240 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • 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
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Where

1 site
Yale University
New Haven, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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