Nicotine pouches vs. patches: can they help appalachian smokers quit cigarettes and cut cancer risk?
NCT ID NCT06763536
First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time
Summary
This trial compares oral nicotine pouches (like ZYN) with standard nicotine replacement therapy (patches and lozenges) to help smokers in rural Appalachia reduce or stop cigarette use. The goal is to lower the high rates of lung and oral cancers linked to smoking in this region. Participants must be 21 or older, smoke at least 5 cigarettes daily, and live in a rural Appalachian county.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- oral nicotine pouch (ZYN), nicotine patch, nicotine lozenge
- What this could lead to
- If effective, oral nicotine pouches could offer a less harmful alternative to cigarettes, helping smokers in rural Appalachia reduce their cancer risk.
- What could go wrong
- This is a behavioral intervention trial, not a treatment for cancer itself. Results may vary, and long-term health benefits are not guaranteed.
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 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Dec 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Read and speak English * 21 years or older * Smoke ≥ 5 cigarettes per day for the past year * Willing to use Oral Nicotine Pouches (ONP) or Nicotine Replacement Therapy (NRT) * Live in a rural Appalachian County * Have a smartphone and/or willing to use a smartphone for study purposes (smartphones may be provided to participants for study purposes only) * Willing to blow air into a handheld study device * If capable of becoming pregnant, verbal confirmation of not being pregnant based on urine pregnancy test results Exclusion Criteria: * Report currently using smoking cessation medications, NRT, or actively seeking treatment for smoking cessation * Use of ONPs in past 3 months * Use of Nicotine Replacement Therapies in past 3 months * Use of other tobacco products \> 10 days/month * Unstable or significant medical condition * Unstable or significant psychiatric conditions (past and stable conditions will be allowed) * History of cardiac event or distress within the past 3 months * Live in same household as another study participant. * Currently pregnant, planning to become pregnant within 6 months, or breastfeeding
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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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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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
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Ohio State University Comprehensive Cancer Center
RECRUITINGColumbus, Ohio, 43210, United States
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