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

Recruiting
21 years of age
Both
Phase N/A

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Overview

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.

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

Inclusion Criteria:

  • 21+ years old
  • English literate
  • Currently smoking cigarettes, biochemically confirmed
  • Not planning a smoking cessation attempt or to use smoking cessation pharmacotherapies (NRT, bupropion, varenicline) in the next month.

Exclusion Criteria:

  • Currently using any smoking cessation services and/or pharmacotherapies
  • Currently pregnant or breastfeeding
  • Significant current medical or psychiatric condition
  • Known hypersensitivity to propylene glycol.

Study details

Smoking, Smoking Behaviors, Nicotine Dependence

NCT06077240

Yale University

8 June 2024

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