NCT06763536 Oral Nicotine Pouches Versus Nicotine Replacement Therapy to Reduce Cigarette Use for Smokers in Rural Appalachia
| NCT ID | NCT06763536 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University Comprehensive Cancer Center |
| Condition | Cigarette Smoking-Related Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-06-13 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2025-06-13 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
The Ohio State University Comprehensive Cancer Center
✉ OSUCCCClinicaltrials@osumc.edu📞 800-293-5066
Brittney L Keller-Hamilton, PhD, MPH
PRINCIPAL INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06763536 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Cigarette Smoking-Related Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06763536 currently recruiting?
Yes, NCT06763536 is actively recruiting participants. Contact the research team at OSUCCCClinicaltrials@osumc.edu for enrollment information.
Where is the NCT06763536 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT06763536 clinical trial?
NCT06763536 is sponsored by Ohio State University Comprehensive Cancer Center. The principal investigator is Brittney L Keller-Hamilton, PhD, MPH at Ohio State University Comprehensive Cancer Center. The trial plans to enroll 1,000 participants.