E-cigarette UseNCT06372899
Noncombustible Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers
A study testing E-cigarettes and Oral nicotine pouches in people with E-cigarette Use and Cigarette Smoking, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
This between-subjects study aims to evaluate whether e-cigarettes (ECIGS) versus oral nicotine pouches (ONPS) more readily substitute for combustible cigarettes among 200 cigarette smokers. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- E-cigarette Use, Cigarette Smoking, Harm Reduction
- What is being tested?
- E-cigarettes and Oral nicotine pouches
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2024to 31 Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to communicate fluently in English (i.e. speaking, writing, and reading)
- Male and female smokers who are > 21 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months.
- 5 or more failed quit attempts and the use of smoking cessation medication on at least one prior attempt.
- Have a carbon monoxide (CO) greater than 10 ppm.
- Not using any forms of nicotine regularly other than cigarettes
- Be willing to switch to e-cigarettes or nicotine pouches for 6 weeks.
- Plan to live in the area for the duration of the study.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
Who cannot join
- Smoking Behavior
- Regular use of nicotine-containing products other than cigarettes (e.g., chewing tobacco, snuff, snus, cigars, e-cigs, etc.). Regular e-cigarette and nicotine pouch use is defined as greater than 5 days/past 30 days.
- Participants agreeing to abstain from using nicotine-containing products other than cigarettes for the duration of the study will be considered eligible.
- Current enrollment or plans to enroll in a smoking cessation program over the duration of the study.
- Current use of smoking cessation medication
- Provide a CO breath test reading less than 10 ppm at Intake.
Show all 20Show fewer
- Alcohol and Drug
- History of substance abuse (other than nicotine dependence) in the past 12 months.
- Current alcohol consumption that exceeds 20 standard drinks/week.
- Current use of recreational drugs (other than nicotine and cannabis)
- Breath alcohol reading (BrAC) greater than .000 at Intake.
- Medical
- Women, including all individuals assigned as "female" at birth, who are pregnant, breastfeeding, or planning a pregnancy over the duration of the study period.
- Serious or unstable disease within the past year (e.g. cancer, heart disease). Applicable conditions will be evaluated on a case-by-case basis by the Principal Investigator.
- Psychiatric
- 1. Lifetime history of schizophrenia or psychosis.
- General Exclusion
- Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact subject safety, study data, and/or the study design as determined by the Principal Investigator.
- Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance as determined by the Principal Investigator. Subjects may be deemed ineligible for any of the aforementioned reasons at any point throughout the study, as well as during the initial telephone screen.
- Significant non-compliance with protocol and/or study design as determined by the Principal Investigator. Subjects may be deemed ineligible at any point throughout the study.
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
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Janet Audrain-McGovern, Ph.D., 215-746-7145, audrain@pennmedicine.upenn.edu
About this study
Official title: Alternative Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers
This between-subjects study aims to evaluate whether e-cigarettes (ECIGS) versus oral nicotine pouches (ONPS) more readily substitute for combustible cigarettes among 200 cigarette smokers. After measuring baseline cigarette smoking rate, participants will be randomized to ECIGS or ONPS and be instructed to switch (versus smoking cigarettes) over a 6-week period. Relative reductions in biomarkers of exposure will be measured. ECIG- and ONP-associated subjective reward and the reinforcing value of ECIGS and ONPS relative to combustible cigarettes will be assessed as mechanisms.
Read the detailed description
E-cigarettes (ECIGS), and oral nicotine pouches (ONPs), expose users to few of the chemicals found in cigarette smoke and are thus promising noncombustible harm reduction tools for smokers who would not otherwise quit smoking. For their harm reduction potential to be realized, fundamental questions must be answered. One, can persistent smokers switch from combustible cigarettes to either ECIGS or ONPS? Two, what factors influence switching? Three, does one of these noncombustible alternatives expose users to lower levels of harmful chemicals than the other? The proposed research will fill these gaps in the evidence base by randomizing 200 persistent cigarette smokers to a six-week regimen of ECIGS or ONPS. Baseline smoking rate will be established during days 1-5. After biochemically confirmed overnight smoking abstinence, laboratory visits on days 6 and 7 will assess ECIG and ONP-associated subjective reward and the reinforcing value of either ECIGS or ONPS relative to combustible cigarettes. Participants will switch from cigarette smoking to ECIGS or ONPS for the following six weeks. The primary outcome measure is the longitudinal daily count of cigarettes from baseline to the end of the six-week switch period, measured via a validated collection protocol with cigarettes per day (cpd) at a 6-month follow-up as a secondary endpoint. Changes in biomarkers of potential harm, assessed at baseline and the end of the six-week switch phase, will be secondary outcome measures.
- Conditions
- E-cigarette Use, Cigarette Smoking, Harm Reduction, Tobacco Use
- Being tested
- E-cigarettes, Oral nicotine pouches
- Medical subject headings
- Vaping, Cigarette Smoking, Harm Reduction, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-cigarettesOther
Participants randomized to ECIGS are instructed to switch from smoking combustible cigarettes to using e-cigarettes for 6 weeks. They will be provided with an e-cigarette device and nicotine pods.
Oral nicotine pouchesOther
Participants randomized to ONPS are instructed to switch from smoking combustible cigarettes to using nicotine pouches for 6 weeks. They will be provided with nicotine pouches.
| Study group | Role | What they receive |
|---|---|---|
| ECIGS | Experimental | Participants randomized to ECIGS will be provided with an e-cigarette device and be instructed to switch from smoking combustible cigarettes to using only the study-provided e-cigarette device. Participants will be able to choose between Tobacco, Menthol, Watermelon, and Blueberry flavored nicotine pods. They will receive their supply of nicotine pods in 7-day increments, based on baseline smoking behavior. Receives: Other: E-cigarettes |
| ONPS | Experimental | Participants randomized to ONPS will be provided with oral nicotine pouches and be instructed to switch from smoking combustible cigarettes to using only the study-provided nicotine pouches. Participants will be able to choose between Original, Mint, Berry, and Citrus flavored nicotine pouches. They will receive their supply of nicotine pouches in 7-day increments, based on baseline smoking behavior. Receives: Other: Oral nicotine pouches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarette Consumption
The primary outcome is the longitudinal daily count of cigarettes from baseline to the end of the switch phase. Daily cigarette consumption will be determined by counting the daily spent cigarette filters returned for each of the 42 days (days 8 - 49).
Measured: 42 days (days 8 - 49)
Cigarette Smoking Across Follow-Up
Average cigarettes per day at the 6-month follow-up is a secondary endpoint, measured by the valid and reliable timeline follow-back (TLFB) interview.
Measured: 19 Weeks (Day 50-6-Month Follow-Up)
Secondary outcomes (4)
Biomarkers of Exposure: Carbon Monoxide (CO)
Carbon Monoxide (CO) will be measured using a CO monitor. A CO > 5 ppm indicates combustible cigarette smoking.
Measured: 49 days (days 1-49)
Biomarkers of Exposure: Mean mid-expiratory forced expiratory flow (FEF25% - 75%)
The mean mid-expiratory forced expiratory flow (FEF25% - 75%) is a measure of lung function and inflammation. FEF25% - 75% will be assessed using spirometry according to the American Thoracic Guidelines.
Measured: 49 days (days 1-49)
Biomarkers of Exposure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)
4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) is a primary nitrosamine marker of tobacco exposure and an often-used indicator of carcinogen exposure. NNAL will be measured in urine and assessed through Liquid Chromatography-Tandem Mass Spectrometry per milligram creatinine (LC-MS/MS per mg creatinine).
Measured: 49 days (days 1-49)
Biomarkers of Exposure:1-hydroxypyrene (1-HOP)
1-hydroxypyrene (1-HOP) is a widely used biomarker of carcinogenic polycyclic aromatic hydrocarbon exposure. 1-HOP will be measured in urine and assessed through Liquid Chromatography-Tandem Mass Spectrometry per milligram creatinine (LC-MS/MS per mg creatinine).
Measured: 49 days (days 1-49)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start2 Oct 2024
- Primary completionNov 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E-cigarette UseStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Pennsylvania
- Responsible party
- Principal investigator, Janet E. Audrain-McGovern, PhD, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372899
- Sponsor's protocol ID
- UPCC 02024
- Other IDs
- R01CA290541-01A1, 855140
- Status last verified
- Mar 2026
- First submitted
- 12 Apr 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternative Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers
- ClinicalTrials.gov ID
- NCT06372899
- Acronym / sponsor ID
- UPCC 02024
- Conditions
- E-cigarette Use, Cigarette Smoking, Harm Reduction, Tobacco Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Pennsylvania
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 18 Apr 2024 (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.
This between-subjects study aims to evaluate whether e-cigarettes (ECIGS) versus oral nicotine pouches (ONPS) more readily substitute for combustible cigarettes among 200 cigarette smokers. After measuring baseline cigarette smoking rate, participants will be randomized to ECIGS or ONPS and be instructed to switch (versus smoking cigarettes) over a 6-week period. Relative reductions in biomarkers of exposure will be measured. ECIG- and ONP-associated subjective reward and the reinforcing value of ECIGS and ONPS relative to combustible cigarettes will be assessed as mechanisms.
Detailed description
E-cigarettes (ECIGS), and oral nicotine pouches (ONPs), expose users to few of the chemicals found in cigarette smoke and are thus promising noncombustible harm reduction tools for smokers who would not otherwise quit smoking. For their harm reduction potential to be realized, fundamental questions must be answered. One, can persistent smokers switch from combustible cigarettes to either ECIGS or ONPS? Two, what factors influence switching? Three, does one of these noncombustible alternatives expose users to lower levels of harmful chemicals than the other? The proposed research will fill these gaps in the evidence base by randomizing 200 persistent cigarette smokers to a six-week regimen of ECIGS or ONPS. Baseline smoking rate will be established during days 1-5. After biochemically confirmed overnight smoking abstinence, laboratory visits on days 6 and 7 will assess ECIG and ONP-associated subjective reward and the reinforcing value of either ECIGS or ONPS relative to combustible cigarettes. Participants will switch from cigarette smoking to ECIGS or ONPS for the following six weeks. The primary outcome measure is the longitudinal daily count of cigarettes from baseline to the end of the six-week switch period, measured via a validated collection protocol with cigarettes per day (cpd) at a 6-month follow-up as a secondary endpoint. Changes in biomarkers of potential harm, assessed at baseline and the end of the six-week switch phase, will be secondary outcome measures.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECIGS | Experimental | Other: E-cigarettesParticipants randomized to ECIGS will be provided with an e-cigarette device and be instructed to switch from smoking combustible cigarettes to using only the study-provided e-cigarette device. Participants will be able to choose between Tobacco, Menthol, Watermelon, and Blueberry flavored nicotine pods. They will receive their supply of nicotine pods in 7-day increments, based on baseline smoking behavior. |
| ONPS | Experimental | Other: Oral nicotine pouchesParticipants randomized to ONPS will be provided with oral nicotine pouches and be instructed to switch from smoking combustible cigarettes to using only the study-provided nicotine pouches. Participants will be able to choose between Original, Mint, Berry, and Citrus flavored nicotine pouches. They will receive their supply of nicotine pouches in 7-day increments, based on baseline smoking behavior. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to communicate fluently in English (i.e. speaking, writing, and reading)
- Male and female smokers who are > 21 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months.
- 5 or more failed quit attempts and the use of smoking cessation medication on at least one prior attempt.
- Have a carbon monoxide (CO) greater than 10 ppm.
- Not using any forms of nicotine regularly other than cigarettes
Key exclusion criteria (20 listed)
- Smoking Behavior
- Regular use of nicotine-containing products other than cigarettes (e.g., chewing tobacco, snuff, snus, cigars, e-cigs, etc.). Regular e-cigarette and nicotine pouch use is defined as greater than 5 days/past 30 days.
- Current enrollment or plans to enroll in a smoking cessation program over the duration of the study.
- Current use of smoking cessation medication
- Provide a CO breath test reading less than 10 ppm at Intake.
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-cigarettesParticipants randomized to ECIGS are instructed to switch from smoking combustible cigarettes to using e-cigarettes for 6 weeks. They will be provided with an e-cigarette device and nicotine pods. | Other | ECIGS |
| Oral nicotine pouchesParticipants randomized to ONPS are instructed to switch from smoking combustible cigarettes to using nicotine pouches for 6 weeks. They will be provided with nicotine pouches. | Other | ONPS |
Primary outcome
Cigarette Consumption
Time frame: 42 days (days 8 - 49)
The primary outcome is the longitudinal daily count of cigarettes from baseline to the end of the switch phase. Daily cigarette consumption will be determined by counting the daily spent cigarette filters returned for each of the 42 days (days 8 - 49).
Cigarette Smoking Across Follow-Up
Time frame: 19 Weeks (Day 50-6-Month Follow-Up)
Average cigarettes per day at the 6-month follow-up is a secondary endpoint, measured by the valid and reliable timeline follow-back (TLFB) interview.
4 secondary outcomes
Biomarkers of Exposure: Carbon Monoxide (CO)
Time frame: 49 days (days 1-49)
Biomarkers of Exposure: Mean mid-expiratory forced expiratory flow (FEF25% - 75%)
Time frame: 49 days (days 1-49)
Biomarkers of Exposure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)
Time frame: 49 days (days 1-49)
Biomarkers of Exposure:1-hydroxypyrene (1-HOP)
Time frame: 49 days (days 1-49)
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 12 Mar 2026.
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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.
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-cigarettes and Oral nicotine pouches in people with E-cigarette Use and Cigarette Smoking, run by Abramson Cancer Center at Penn Medicine 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 8 inclusion and 20 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 12 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 Janet Audrain-McGovern, Ph.D. (215-746-7145, audrain@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cigarette Consumption (time frame: 42 days (days 8 - 49)). 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 12 Mar 2026.