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Oral Nicotine Pouches Versus Nicotine Replacement Therapy to Reduce Cigarette Use for Smokers in Rural Appalachia

Testing Oral Nicotine Pouches to Reduce Smoking-Related Cancer in Rural Appalachia

Who can join

Ages 21 and older · All sexes · Healthy volunteers welcome

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

About the study

This clinical trial compares the use of oral nicotine pouches to nicotine replacement therapy, consisting of nicotine patches and lozenges, to reduce cigarette use in smokers living in rural Appalachia. The lung and oral cancers that plague Appalachia are fueled by cigarette smoking. Oral nicotine pouches which contain nicotine but no tobacco leaf, present a new opportunity to reduce cancer risk among Appalachian adults who smoke. Oral nicotine pouches and nicotine replacement therapy may work well to reduce cigarette use for smokers in rural Appalachia.

What is being tested

• Carbon Monoxide Measurement (other)
• Nicotine Lozenge (other)
• Oral Nicotine Pouch (other)
• Nicotine Patch (other)
• Survey Administration (other)
• Check-in Phone Calls (other)

Sponsor: Ohio State University Comprehensive Cancer Center · Participants: 1,000 · Started: Jun 13, 2025

Contact the study team

• The Ohio State University Comprehensive Cancer Center · Phone: 800-293-5066

Official record on ClinicalTrials.gov — NCT06763536

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.