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

NCT06763536 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2025-06-22

No results posted yet for this study

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.

Conditions

  • Cigarette Smoking-Related Carcinoma

Interventions

OTHER

Carbon Monoxide Measurement

Undergo carbon monoxide measurement

OTHER

Nicotine Lozenge

Use nicotine lozenge

OTHER

Oral Nicotine Pouch

Use oral nicotine pouch

OTHER

Nicotine Patch

Use nicotine patch

OTHER

Survey Administration

measurements; data gathering

OTHER

Check-in Phone Calls

Check-in phone calls to study participants

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Brittney L Keller-Hamilton, PhD, MPH · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-13
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06763536 on ClinicalTrials.gov