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Nicotine pouches under the microscope: will they help or harm rural ohio?

NCT ID NCT05730439

Knowledge-focused Sponsor: Ohio State University Comprehensive Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study examined how nicotine pouches (like ZYN and Rogue) affect people who use smokeless tobacco in rural Ohio and Appalachia. Researchers measured nicotine levels in the blood and asked participants about their intentions to use these products. The goal was to understand whether nicotine pouches might become a popular alternative to traditional smokeless tobacco and what that could mean for public health.

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 (ZYN and Rogue brands)
What this could lead to
If successful, this research could help public health officials understand whether nicotine pouches might help people switch from smokeless tobacco or lead to new nicotine addiction.
What could go wrong
This is an early-phase study with only 71 participants, so results may not apply to broader populations. It measures short-term effects and intentions, not long-term health outcomes.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

71 people

The number who actually took part.

Started

May 2023

Finished

Aug 2024

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Age 21 years or older * Reside in an Ohio Appalachian county or surrounding rural area * Willing to complete study procedures, including abstaining from all tobacco, nicotine, and marijuana for 12 hours before clinic visits * Ability to read and speak English * Daily use of smokeless tobacco for the past 3 months Exclusion Criteria: * Use tobacco products other than smokeless tobacco \> 10 days per month * Unstable or significant psychiatric conditions for \> 1 year (past and stable conditions will be allowed) * Pregnant, planning to become pregnant, or breastfeeding * History of cardiac event or distress, including but not limited to uncontrolled high blood pressure, chest pain, significant oral lesions, throat, mouth, or other oral cancer, and shortness of breath within the past 1 year * Working with a cessation counselor, using cessation devices such as Chantix or Wellbutrin, or planning to quit within the next 3 months * Self-reported diagnosis of lung disease including asthma (if uncontrolled or worse than usual), cystic fibrosis, throat, tongue, or other oral cancer, lung cancer, or chronic obstructive pulmonary disease

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tobacco-related carcinoma

Contacts and locations

Locations

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

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