RecruitingNot ApplicableNCT06763536

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

Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

1,000 participants

Start Date

Jun 13, 2025

Study Type

INTERVENTIONAL

Conditions

Cigarette Smoking-Related Carcinoma

Summary

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.

Eligibility

Min Age: 21 Years

Inclusion Criteria8

Read and speak English
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 Criteria9

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