Nicotine pouches tested as a way to help smokers quit
NCT ID NCT06043362
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether nicotine pouches can help smokers reduce their cigarette use. 375 smokers who smoke at least 5 cigarettes a day will be given different strengths and flavors of nicotine pouches to use for 16 weeks. Researchers will measure changes in cigarette smoking and exposure to harmful chemicals.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nicotine pouches (0 mg, 3 mg, or 6 mg nicotine, in smooth or wintergreen flavor)
- What this could lead to
- If it works, this could show that nicotine pouches are a safer alternative for smokers who want to cut down on cigarettes.
- What could go wrong
- This is an early-stage study with no placebo group for comparison. The pouches still deliver nicotine, which is addictive, and long-term health effects are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 375 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Aug 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 to 70 years
- 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: * Commonly smoke ≥ 5 cigarettes per day (at least 2 days/week) for at least the prior 12 months * Exhaled CO measurement of ≥ 6 parts per million at baseline * Must be interested in reducing cigarette consumption by at least 50% and willing to try nicotine pouches * Able to understand, read and write in English * Access to e-mail and a smartphone/computer that has reliable internet connection * Able to understand and give informed consent Exclusion Criteria: * Plans to quit smoking within the next 30 days * Currently pregnant, breastfeeding, or planning to become pregnant in the next 6 months * Recent (past 3 months) unstable illness that may increase risks of participation or ability to participate fully (e.g. hospitalization for a mental health condition or substance use disorder in prior 6 months, stroke or myocardial infarction in the past year) * Serious current respiratory diseases (e.g. exacerbations of asthma or chronic obstructive pulmonary disease \[COPD\], requiring oxygen or oral prednisone), kidney disease (e.g. requiring dialysis), liver disease (e.g cirrhosis), or any medical disorder/medication that may affect participant safety or biomarker data * Use of a nicotine pouch or other non-cigarette nicotine product (e-cigarette, pipe, cigar, chew, snus, hookah, IQOS) for 5 or more days in the past 28 days * Use of illegal drugs daily or weekly in the past 3 months * Use of combustible (smoked) recreational or medical marijuana weekly in the past 3 months (less frequent smoked medical marijuana or use of other forms of medical marijuana are ok) * Other member of the household currently participating in the study * Any other condition that in the opinion of the investigator would make it unlikely that the participant could comply with the study protocol
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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
2 sites. 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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Penn State College of Medicine
RECRUITINGHershey, Pennsylvania, 17033, United States
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University of Texas MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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