Effects of E-cigs vs Pouches on Cigarette Smoking and Addiction (NCT06077240)
Evaluating The Effects Of E-cigarettes Versus Oral Nicotine Pouches and Product Constituents (Menthol Flavor, Nicotine Concentration) On Adult Cigarette Smoking and Addiction
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Yale University โ New Haven, Connecticut
Age range: 21 Years
๐งช Interventions in This Study
- E-cigarette with 2.4% Nicotine with Menthol and Tobacco Flavors (BEHAVIORAL)
- E-cigarette with 2.4% Nicotine with Tobacco Flavor Only (BEHAVIORAL)
- E-cigarette with 5% Nicotine with Menthol and Tobacco Flavors (BEHAVIORAL)
- E-cigarette with 5% Nicotine with Tobacco Flavor Only (BEHAVIORAL)
- Tobacco Pouches with 3mg Nicotine with Menthol and Tobacco Flavors (BEHAVIORAL)
- Tobacco Pouches with 3mg Nicotine with Tobacco Flavor Only (BEHAVIORAL)
- Tobacco Pouches with 6mg Nicotine with Menthol and Tobacco Flavors (BEHAVIORAL)
- Tobacco Pouches with 6mg Nicotine with Tobacco Flavor Only (BEHAVIORAL)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Yale University โ New Haven, Connecticut
๐ Contact the Study Coordinator
Phone: (203) 200-1470
Email: lisa.fucito@yale.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.