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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorYale University

About this trial

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 criteria

Qualifiers

21+ years old

English literate

Currently smoking cigarettes, biochemically confirmed

Disqualifiers

Currently using smoking cessation pharmacotherapies (NRT, bupropion, varenicline)

Currently pregnant or breastfeeding

Significant current medical or psychiatric condition

Known hypersensitivity to propylene glycol

Trial design

Treatments tested in this trial

  • E-cigarette with 2.4% Nicotine with Menthol and Tobacco Flavors
  • E-cigarette with 2.4% Nicotine with Tobacco Flavor Only
  • E-cigarette with 5% Nicotine with Menthol and Tobacco Flavors
  • E-cigarette with 5% Nicotine with Tobacco Flavor Only
  • Tobacco Pouches with 3mg Nicotine with Menthol and Tobacco Flavors
  • Tobacco Pouches with 3mg Nicotine with Tobacco Flavor Only
  • Tobacco Pouches with 6mg Nicotine with Menthol and Tobacco Flavors
  • Tobacco Pouches with 6mg Nicotine with Tobacco Flavor Only

Treatment groups

256 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Yale University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator