SmokingNCT06077240
Effects of E-cigs vs Pouches on Cigarette Smoking and Addiction
A study testing E-cigarette with 2.4% Nicotine with Menthol and Tobacco Flavors, E-cigarette with 2.4% Nicotine with Tobacco Flavor Only and E-cigarette with 5% Nicotine with Menthol and Tobacco Flavors in people with Smoking and Smoking Behaviors, run by Yale University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Smoking, Smoking Behaviors, Nicotine Dependence
- What is being tested?
- E-cigarette with 2.4% Nicotine with Menthol and Tobacco Flavors, E-cigarette with 2.4% Nicotine with Tobacco Flavor Only and E-cigarette with 5% Nicotine with Menthol and Tobacco Flavors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2024to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21+ years old
- English literate
- Currently smoking cigarettes, biochemically confirmed
Who cannot join
- Currently using smoking cessation pharmacotherapies (NRT, bupropion, varenicline)
- Currently pregnant or breastfeeding
- Significant current medical or psychiatric condition
- Known hypersensitivity to propylene glycol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale University
New Haven, Connecticut, 06520
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking, Smoking Behaviors, Nicotine Dependence
- Being tested
- 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
- Medical subject headings
- Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-cigarette with 2.4% Nicotine with Menthol and Tobacco FlavorsBehavioural
Flavor availability is menthol and tobacco/unflavored with lower nicotine concentration.
E-cigarette with 2.4% Nicotine with Tobacco Flavor OnlyBehavioural
Flavor availability is tobacco/unflavored only with lower nicotine concentration.
E-cigarette with 5% Nicotine with Menthol and Tobacco FlavorsBehavioural
Flavor availability is menthol and tobacco/unflavored with higher nicotine concentration.
E-cigarette with 5% Nicotine with Tobacco Flavor OnlyBehavioural
Flavor availability is tobacco/unflavored only with higher nicotine concentration.
Tobacco Pouches with 3mg Nicotine with Menthol and Tobacco FlavorsBehavioural
Flavor availability is menthol and tobacco/unflavored with lower nicotine concentration.
Tobacco Pouches with 3mg Nicotine with Tobacco Flavor OnlyBehavioural
Flavor availability is tobacco/unflavored only with lower nicotine concentration.
Tobacco Pouches with 6mg Nicotine with Menthol and Tobacco FlavorsBehavioural
Flavor availability is menthol and tobacco/unflavored with higher nicotine concentration.
Tobacco Pouches with 6mg Nicotine with Tobacco Flavor OnlyBehavioural
Flavor availability is tobacco/unflavored only with higher nicotine concentration.
| Study group | Role | What they receive |
|---|---|---|
| E-cigarettes | Experimental | 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. Receives: Behavioral: E-cigarette with 2.4% Nicotine with Menthol and Tobacco Flavors; Behavioral: E-cigarette with 2.4% Nicotine with Tobacco Flavor Only; Behavioral: E-cigarette with 5% Nicotine with Menthol and Tobacco Flavors; Behavioral: E-cigarette with 5% Nicotine with Tobacco Flavor Only |
| Nicotine Pouches | Experimental | 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. Receives: Behavioral: Tobacco Pouches with 3mg Nicotine with Menthol and Tobacco Flavors; Behavioral: Tobacco Pouches with 3mg Nicotine with Tobacco Flavor Only; Behavioral: Tobacco Pouches with 6mg Nicotine with Menthol and Tobacco Flavors; Behavioral: Tobacco Pouches with 6mg Nicotine with Tobacco Flavor Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1: Average number of cigarettes smoked per day
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.
Measured: From baseline to week 4
Aim 2: Percent of days using non-combustible product
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.
Measured: From baseline to week 4
Secondary outcomes (5)
Aim 1: Percent of days abstinent from cigarettes
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.
Measured: From baseline to week 4
Aim 1: Biochemically verified 7 day point-prevalent abstinence from cigarettes
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
Measured: Week 4
Aim 1: Cigarette Dependence
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.
Measured: From baseline to week 4
Aim 2: Average use of non-combustible products per day
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.
Measured: From baseline to week 4
Aim 2: Continued use of non-combustible products
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.
Measured: Week 4 to 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start20 Aug 2024
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Lisa Fucito, PhD, Principal investigator, Yale UniversityKrysten Bold, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077240
- Sponsor's protocol ID
- 2000035286
- Other IDs
- U54DA036151
- Status last verified
- Mar 2026
- First submitted
- 4 Oct 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available through the NIH repository- National Addiction \& HIV Data Archive Program (NAHDAP)
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating The Effects Of E-cigarettes Versus Oral Nicotine Pouches and Product Constituents (Menthol Flavor, Nicotine Concentration) On Adult Cigarette Smoking and Addiction
- ClinicalTrials.gov ID
- NCT06077240
- Acronym / sponsor ID
- 2000035286
- Conditions
- Smoking, Smoking Behaviors, Nicotine Dependence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-cigarettes | Experimental | Behavioral: E-cigarette with 2.4% Nicotine with Menthol and Tobacco Flavors, Behavioral: E-cigarette with 2.4% Nicotine with Tobacco Flavor Only, Behavioral: E-cigarette with 5% Nicotine with Menthol and Tobacco Flavors, Behavioral: E-cigarette with 5% Nicotine with Tobacco Flavor OnlyAdults 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. |
| Nicotine Pouches | Experimental | Behavioral: Tobacco Pouches with 3mg Nicotine with Menthol and Tobacco Flavors, Behavioral: Tobacco Pouches with 3mg Nicotine with Tobacco Flavor Only, Behavioral: Tobacco Pouches with 6mg Nicotine with Menthol and Tobacco Flavors, Behavioral: Tobacco Pouches with 6mg Nicotine with Tobacco Flavor OnlyAdults 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 21+ years old
- English literate
- Currently smoking cigarettes, biochemically confirmed
Key exclusion criteria (4 listed)
- Currently using smoking cessation pharmacotherapies (NRT, bupropion, varenicline)
- Currently pregnant or breastfeeding
- Significant current medical or psychiatric condition
- Known hypersensitivity to propylene glycol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-cigarette with 2.4% Nicotine with Menthol and Tobacco FlavorsFlavor availability is menthol and tobacco/unflavored with lower nicotine concentration. | Behavioural | E-cigarettes |
| E-cigarette with 2.4% Nicotine with Tobacco Flavor OnlyFlavor availability is tobacco/unflavored only with lower nicotine concentration. | Behavioural | E-cigarettes |
| E-cigarette with 5% Nicotine with Menthol and Tobacco FlavorsFlavor availability is menthol and tobacco/unflavored with higher nicotine concentration. | Behavioural | E-cigarettes |
| E-cigarette with 5% Nicotine with Tobacco Flavor OnlyFlavor availability is tobacco/unflavored only with higher nicotine concentration. | Behavioural | E-cigarettes |
| Tobacco Pouches with 3mg Nicotine with Menthol and Tobacco FlavorsFlavor availability is menthol and tobacco/unflavored with lower nicotine concentration. | Behavioural | Nicotine Pouches |
| Tobacco Pouches with 3mg Nicotine with Tobacco Flavor OnlyFlavor availability is tobacco/unflavored only with lower nicotine concentration. | Behavioural | Nicotine Pouches |
| Tobacco Pouches with 6mg Nicotine with Menthol and Tobacco FlavorsFlavor availability is menthol and tobacco/unflavored with higher nicotine concentration. | Behavioural | Nicotine Pouches |
| Tobacco Pouches with 6mg Nicotine with Tobacco Flavor OnlyFlavor availability is tobacco/unflavored only with higher nicotine concentration. | Behavioural | Nicotine Pouches |
Primary outcome
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.
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.
5 secondary outcomes
Aim 1: Percent of days abstinent from cigarettes
Time frame: From baseline to week 4
Aim 1: Biochemically verified 7 day point-prevalent abstinence from cigarettes
Time frame: Week 4
Aim 1: Cigarette Dependence
Time frame: From baseline to week 4
Aim 2: Average use of non-combustible products per day
Time frame: From baseline to week 4
Aim 2: Continued use of non-combustible products
Time frame: Week 4 to 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Yes. IPD will be available through the NIH repository- National Addiction \& HIV Data Archive Program (NAHDAP)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Fucito, PhD principal investigator
Yale University
Krysten Bold, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-cigarette with 2.4% Nicotine with Menthol and Tobacco Flavors, E-cigarette with 2.4% Nicotine with Tobacco Flavor Only and E-cigarette with 5% Nicotine with Menthol and Tobacco Flavors in people with Smoking and Smoking Behaviors, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa M. Fucito, PhD (203-200-1470, lisa.fucito@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1: Average number of cigarettes smoked per day (time frame: From baseline to week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.