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NCT06077240NARecruiting

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

Yale University

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

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

Interventions

BEHAVIORAL

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

Interested in This Trial?

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Conditions

SmokingSmoking BehaviorsNicotine Dependence

Locations

Yale University

New Haven, Connecticut 06520

United States