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

Recruiting now · Not applicable

Conditions studied: Cigarette Smoking-Related Carcinoma

In brief

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.

Key facts

Study ID

NCT06763536

Run by

Ohio State University Comprehensive Cancer Center

People needed

1000

Starts

2025-06-13

Expected to finish

2028-12-31

Last updated by the study team

2026-06-30

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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