Study pits e-cigarettes against nicotine pouches to help smokers quit
NCT ID NCT06372899
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether e-cigarettes or oral nicotine pouches can help people who smoke cigarettes cut down or switch completely. Two hundred adult smokers who have tried to quit before will be randomly assigned to use one of these products instead of cigarettes for six weeks. Researchers will measure how many cigarettes they smoke and check their health markers like carbon monoxide levels.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Able to communicate fluently in English (i.e. speaking, writing, and reading) 2. 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. 3. 5 or more failed quit attempts and the use of smoking cessation medication on at least one prior attempt. 4. Have a carbon monoxide (CO) greater than 10 ppm. 5. Not using any forms of nicotine regularly other than cigarettes 6. Be willing to switch to e-cigarettes or nicotine pouches for 6 weeks. 7. Plan to live in the area for the duration of the study. 8. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form. Exclusion Criteria: Smoking Behavior 1. 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. a. Participants agreeing to abstain from using nicotine-containing products other than cigarettes for the duration of the study will be considered eligible. 2. Current enrollment or plans to enroll in a smoking cessation program over the duration of the study. 3. Current use of smoking cessation medication 4. Provide a CO breath test reading less than 10 ppm at Intake. Alcohol and Drug 1. History of substance abuse (other than nicotine dependence) in the past 12 months. 2. Current alcohol consumption that exceeds 20 standard drinks/week. 3. Current use of recreational drugs (other than nicotine and cannabis) 4. Breath alcohol reading (BrAC) greater than .000 at Intake. Medical 1. Women, including all individuals assigned as "female" at birth, who are pregnant, breastfeeding, or planning a pregnancy over the duration of the study period. 2. 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 1. 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. 2. 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. 3. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Other studies related to the condition(s) this trial covers.
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