Oral nicotine pouches versus patches and lozenges to reduce cigarette use in rural Appalachia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.