Oral nicotine pouches versus patches and lozenges to reduce cigarette use in rural Appalachia
Testing Oral Nicotine Pouches to Reduce Smoking-Related Cancer in Rural Appalachia
This compares oral nicotine pouches with nicotine patches and lozenges to see if they help adults in rural Appalachia who smoke cut down or quit cigarettes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06763536 on ClinicalTrials.gov |
What this trial studies
Adults who smoke at least five cigarettes per day and live in rural Appalachian counties are randomized to receive either oral nicotine pouches (ONPs) or standard nicotine replacement therapy (patches and lozenges). Participants sample different flavors and strengths for two weeks to choose a preferred product, then use that product in place of cigarettes for a 12-week intervention with regular surveys and exhaled carbon monoxide (CO) checks. The study measures short-term switching and abstinence, product appeal, cravings, withdrawal relief, perceived dependence, and sustained tobacco behaviors through a 14-week post-intervention follow-up. Smartphones and handheld CO devices are used for data collection when needed.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults 21 or older who live in a rural Appalachian county, smoke ≥5 cigarettes per day, and are willing to try ONPs or NRT and use a smartphone for study tasks.
Not a fit: People currently using cessation medications or NRT, who used ONPs or NRT within the past three months, who use other tobacco products frequently, or who have unstable medical or psychiatric conditions are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a more acceptable option to help Appalachian smokers reduce cigarette use and lower lung and oral cancer risk.
How similar studies have performed: Nicotine patches and lozenges have well-established efficacy for quitting, while oral nicotine pouches are a newer, less-studied alternative with limited clinical trial evidence to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Columbus, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Brittney L Keller-Hamilton, PhD, MPH — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State University Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.