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

March 17, 2026 updated by: Yale University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

256

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: E-cigarette with 2.4% Nicotine with Menthol and Tobacco Flavors
Flavor availability is menthol and tobacco/unflavored with lower nicotine concentration.
Behavioral: E-cigarette with 2.4% Nicotine with Tobacco Flavor Only
Flavor availability is tobacco/unflavored only with lower nicotine concentration.
Behavioral: E-cigarette with 5% Nicotine with Menthol and Tobacco Flavors
Flavor availability is menthol and tobacco/unflavored with higher nicotine concentration.
Behavioral: E-cigarette with 5% Nicotine with Tobacco Flavor Only
Flavor availability is tobacco/unflavored only with higher nicotine concentration.
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.
Behavioral: Tobacco Pouches with 3mg Nicotine with Menthol and Tobacco Flavors
Flavor availability is menthol and tobacco/unflavored with lower nicotine concentration.
Behavioral: Tobacco Pouches with 3mg Nicotine with Tobacco Flavor Only
Flavor availability is tobacco/unflavored only with lower nicotine concentration.
Behavioral: Tobacco Pouches with 6mg Nicotine with Menthol and Tobacco Flavors
Flavor availability is menthol and tobacco/unflavored with higher nicotine concentration.
Behavioral: Tobacco Pouches with 6mg Nicotine with Tobacco Flavor Only
Flavor availability is tobacco/unflavored only with higher nicotine concentration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to week 4
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.
From baseline to week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to week 4
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
Week 4
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.
From baseline to week 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.
From baseline to week 4
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.
Week 4 to 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Lisa Fucito, PhD, Yale University
  • Principal Investigator: Krysten Bold, PhD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2024

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

October 4, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000035286
  • U54DA036151 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be available through the NIH repository- National Addiction & HIV Data Archive Program (NAHDAP)

IPD Sharing Time Frame

After study completion

IPD Sharing Access Criteria

Available upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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