Study on E-cigarettes vs. Nicotine Pouches for Smoking Cessation

This study is looking for 256 adults who currently smoke cigarettes and are willing to try switching to other products. It compares how effective e-cigarettes and nicotine pouches are at helping people reduce or stop smoking. You would be randomly assigned to use either an e-cigarette or a nicotine pouch for 4 weeks. The e-cigarettes come in different nicotine strengths (2.4% or 5%) and flavors (menthol and tobacco, or tobacco only). The nicotine pouches also come in different strengths (3mg or 6mg) and flavors (menthol and tobacco, or tobacco only). Researchers will measure how many cigarettes you smoke daily and how often you use the assigned product. To join, you must be at least 21 years old, speak English, and currently smoke cigarettes. You cannot be pregnant, breastfeeding, or using other smoking cessation medications. The study's current status is unclear.

Study design
This is an interventional study planning to enroll 256 participants. You would be randomly assigned to one of several groups testing different e-cigarette or nicotine pouch options.
What's involved
You would have an intake visit lasting about 60 minutes, followed by four bi-weekly visits (in person or by video call) lasting about 30 minutes each, over a total of 6 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your cigarette smoking and product use will be measured from the start of the study until week 4.

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NCT06077240

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

Recruiting
NAAges 21+Interventional
Yale University
~256 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:E-cigarette with 2.4% Nicotine with Menthol and Tobacco FlavorsE-cigarette with 2.4% Nicotine with Tobacco Flavor OnlyE-cigarette with 5% Nicotine with Menthol and Tobacco FlavorsE-cigarette with 5% Nicotine with Tobacco Flavor OnlyTobacco Pouches with 3mg Nicotine with Menthol and Tobacco FlavorsTobacco Pouches with 3mg Nicotine with Tobacco Flavor Only

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Aim 1: Average number of cigarettes smoked per day
Measured over From baseline to week 4
+1 more outcome measured
Smoking
Smoking Behaviors
Nicotine Dependence
1 sites across 1 states
Connecticut1
  • Lisa Fucito, PhD · PRINCIPAL_INVESTIGATOR · Yale University
  • Krysten Bold, PhD · PRINCIPAL_INVESTIGATOR · Yale University

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Eligibility criteria

Inclusion

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

Exclusion

Currently using smoking cessation pharmacotherapies (NRT, bupropion, varenicline)
Currently pregnant or breastfeeding
Significant current medical or psychiatric condition
Known hypersensitivity to propylene glycol
  • Aim 1: Average number of cigarettes smoked per dayFrom 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.

  • Aim 2: Percent of days using non-combustible productFrom 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.