RecruitingNot ApplicableNCT06077240

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


Sponsor

Yale University

Enrollment

256 participants

Start Date

Aug 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 Years

Inclusion Criteria3

  • + years old
  • English literate
  • Currently smoking cigarettes, biochemically confirmed

Exclusion Criteria4

  • Currently using smoking cessation pharmacotherapies (NRT, bupropion, varenicline)
  • Currently pregnant or breastfeeding
  • Significant current medical or psychiatric condition
  • Known hypersensitivity to propylene glycol

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALE-cigarette with 2.4% Nicotine with Menthol and Tobacco Flavors

Flavor availability is menthol and tobacco/unflavored with lower nicotine concentration.

BEHAVIORALE-cigarette with 2.4% Nicotine with Tobacco Flavor Only

Flavor availability is tobacco/unflavored only with lower nicotine concentration.

BEHAVIORALE-cigarette with 5% Nicotine with Menthol and Tobacco Flavors

Flavor availability is menthol and tobacco/unflavored with higher nicotine concentration.

BEHAVIORALE-cigarette with 5% Nicotine with Tobacco Flavor Only

Flavor availability is tobacco/unflavored only with higher nicotine concentration.

BEHAVIORALTobacco Pouches with 3mg Nicotine with Menthol and Tobacco Flavors

Flavor availability is menthol and tobacco/unflavored with lower nicotine concentration.

BEHAVIORALTobacco Pouches with 3mg Nicotine with Tobacco Flavor Only

Flavor availability is tobacco/unflavored only with lower nicotine concentration.

BEHAVIORALTobacco Pouches with 6mg Nicotine with Menthol and Tobacco Flavors

Flavor availability is menthol and tobacco/unflavored with higher nicotine concentration.

BEHAVIORALTobacco Pouches with 6mg Nicotine with Tobacco Flavor Only

Flavor availability is tobacco/unflavored only with higher nicotine concentration.


Locations(1)

Yale University

New Haven, Connecticut, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06077240


Related Trials