Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
Healthy Volunteers
NCT06763536

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

Led by Ohio State University Comprehensive Cancer Center · Updated on 2025-06-22

1000

Participants Needed

1

Research Sites

185 weeks

Total Duration

On this page

Sponsors

O

Ohio State University Comprehensive Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Read and speak English
  • 21 years or older
  • Smoke at least 5 cigarettes per day for the past year
  • Willing to use Oral Nicotine Pouches or Nicotine Replacement Therapy
  • Live in a rural Appalachian County
  • Have a smartphone or willing to use one for the study
  • Willing to blow air into a handheld study device
  • If able to become pregnant, confirm not pregnant by urine pregnancy test
Not Eligible

You will not qualify if you...

  • Currently using smoking cessation medications, nicotine replacement therapy, or actively seeking smoking cessation treatment
  • Used oral nicotine pouches in the past 3 months
  • Used nicotine replacement therapies in the past 3 months
  • Use other tobacco products more than 10 days per month
  • Have unstable or significant medical conditions
  • Have unstable or significant psychiatric conditions (stable past conditions allowed)
  • Had a cardiac event or distress within the past 3 months
  • Live in the same household as another study participant
  • Currently pregnant, planning pregnancy within 6 months, or breastfeeding

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

T

The Ohio State University Comprehensive Cancer Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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