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Nicotine pouches vs. patches: can they help appalachian smokers quit cigarettes and cut cancer risk?

NCT ID NCT06763536

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

21 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * 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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

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