Recruiting

E-cigs vs. Pouches

Sponsor:

Yale University

Code:

NCT06077240

Conditions

Smoking

Smoking Behaviors

Nicotine Dependence

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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.

Conditions

Smoking

Smoking Behaviors

Nicotine Dependence

Study ID

NCT06077240

Start date

Aug 20, 2024

Status verified date

Mar, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

256 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: E-cigarettes

Adults who smoke cigarettes will be randomized to receive e-cigarettes 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) or lower (2.4% e-cig). Participants will return for bi-weekly research visits (in person or remote videocall) to complete measures for study aims. They 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.

experimental: Nicotine Pouches

Adults who smoke cigarettes will be randomized to receive 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 (6mg pouch) or lower (3mg pouch). Participants will return for bi-weekly research visits (in person or remote videocall) to complete measures for study aims. They 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.

Interventions

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

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

E-cigarette with 2.4% Nicotine with Tobacco Flavor Only

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

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

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

E-cigarette with 5% Nicotine with Tobacco Flavor Only

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

Tobacco Pouches with 3mg Nicotine with Menthol and Tobacco Flavors

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

Tobacco Pouches with 3mg Nicotine with Tobacco Flavor Only

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

Tobacco Pouches with 6mg Nicotine with Menthol and Tobacco Flavors

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

Tobacco Pouches with 6mg Nicotine with Tobacco Flavor Only

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

Primary outcome measure

  • Aim 1: Average number of cigarettes smoked per day [ Time Frame: From baseline to week 4 ]
  • Aim 2: Percent of days using non-combustible product [ Time Frame: From baseline to week 4 ]

Central Contacts and Locations

Central contacts

Lisa M. Fucito, PhD

203-200-1470lisa.fucito@yale.edu

Krysten W Bold, PhD

203-974-7603krysten.bold@yale.edu

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Yale University

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-03-19.