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NCT Number: NCT06077240

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

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.

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Key information

Conditions

Smoking Behavior Chemically-Induced Disorders Mental Disorders Nicotine Dependence Smoking Behaviors Substance-Related Disorders Tobacco Use Disorder

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06520, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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

E-cigarette with 2.4% Nicotine with Tobacco Flavor Only

Behavioral

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

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

Behavioral

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

E-cigarette with 5% Nicotine with Tobacco Flavor Only

Behavioral

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

Tobacco Pouches with 3mg Nicotine with Menthol and Tobacco Flavors

Behavioral

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

Tobacco Pouches with 3mg Nicotine with Tobacco Flavor Only

Behavioral

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

Tobacco Pouches with 6mg Nicotine with Menthol and Tobacco Flavors

Behavioral

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

Tobacco Pouches with 6mg Nicotine with Tobacco Flavor Only

Behavioral

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

Primary outcomes

  1. Aim 1: Average number of cigarettes smoked per day

    Time frame: From baseline to week 4

    Participants will report the total number of cigarettes consumed each day using a well-validated timeline follow-back (TLFB) interview method to assess number of cigarettes smoked per day continuously over the 4-week observational period for each product condition.

  2. Aim 2: Percent of days using non-combustible product

    Time frame: From baseline to week 4

    Participants will report daily use of e-cigarettes or nicotine pouches using a well-validated timeline follow-back (TLFB) interview method continuously over the 4-week observational period to determine the total percent days use of the non-combustible product for each product condition.

Secondary outcomes

  1. Aim 1: Percent of days abstinent from cigarettes

    Time frame: From baseline to week 4

    Participants will report the total number of cigarettes consumed each day using a well-validated timeline follow-back (TLFB) interview method to assess number of cigarettes smoked per day continuously over the 4-week observational period to determine the total percent days abstinent (smoke-free) for each product condition.

  2. Aim 1: Biochemically verified 7 day point-prevalent abstinence from cigarettes

    Time frame: Week 4

    Complete switching from cigarettes will be assessed at the end of the study period using self-reported TLFB methods and biochemical verification with expired breath carbon monoxide (CO) testing (CO < 5ppm) to determine rates of 7-day point-prevalent abstinence

  3. Aim 1: Cigarette Dependence

    Time frame: From baseline to week 4

    Cigarette dependence will be measured using the 4-item PROMIS® Short Form v1.0 - Smoking Nicotine Dependence for All Smokers 4a. Each item is scored from 1-5 with the range of scores from 4-20 with higher scores representing greater cigarette dependence.

  4. Aim 2: Average use of non-combustible products per day

    Time frame: From baseline to week 4

    Participants will report daily e-cigarette and nicotine pouch quantity and frequency consumed using a well-validated timeline follow-back (TLFB) interview method to use continuously over the 4-week observational period for each product condition.

  5. Aim 2: Continued use of non-combustible products

    Time frame: Week 4 to 6

    Participants will report daily use of e-cigarettes or nicotine pouches using a well-validated timeline follow-back (TLFB) interview method to determine the total percent days use of the non-combustible product for each product condition during the follow-up period.

Study contacts

Contact information is provided by the study sponsor or research team.

Krysten W Bold, PhD

CONTACT

[email protected]

203-974-7603

Lisa M. Fucito, PhD

CONTACT

[email protected]

203-200-1470

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Evaluating The Effects Of E-cigarettes Versus Oral Nicotine Pouches and Product Constituents (Menthol Flavor, Nicotine Concentration) On Adult Cigarette Smoking and Addiction

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 11, 2023
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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