NCT06077240

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

Evaluating The Effects Of E-cigarettes Versus Oral Nicotine Pouches and Product Constituents (Menthol Flavor, Nicotine Concentration) On Adult Cigarette Smoking and Addiction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Smoking
• Smoking Behaviors
• Nicotine Dependence

Interventions

Type	Name	Description
BEHAVIORAL	E-cigarette with 2.4% Nicotine with Menthol and Tobacco Flavors	Flavor availability is menthol and tobacco/unflavored with lower nicotine concentration.
BEHAVIORAL	E-cigarette with 2.4% Nicotine with Tobacco Flavor Only	Flavor availability is tobacco/unflavored only with lower nicotine concentration.
BEHAVIORAL	E-cigarette with 5% Nicotine with Menthol and Tobacco Flavors	Flavor availability is menthol and tobacco/unflavored with higher nicotine concentration.
BEHAVIORAL	E-cigarette with 5% Nicotine with Tobacco Flavor Only	Flavor availability is tobacco/unflavored only with higher nicotine concentration.
BEHAVIORAL	Tobacco Pouches with 3mg Nicotine with Menthol and Tobacco Flavors	Flavor availability is menthol and tobacco/unflavored with lower nicotine concentration.
BEHAVIORAL	Tobacco Pouches with 3mg Nicotine with Tobacco Flavor Only	Flavor availability is tobacco/unflavored only with lower nicotine concentration.
BEHAVIORAL	Tobacco Pouches with 6mg Nicotine with Menthol and Tobacco Flavors	Flavor availability is menthol and tobacco/unflavored with higher nicotine concentration.
BEHAVIORAL	Tobacco Pouches with 6mg Nicotine with Tobacco Flavor Only	Flavor availability is tobacco/unflavored only with higher nicotine concentration.

Timeline

• Start date: 2024-08-20
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2023-10-11
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States