RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Testing Oral Nicotine Pouches to Reduce Smoking-Related Cancer in Rural Appalachia

Quick Facts

Study Start:2025-06-13
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06763536

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Read and speak English
  2. * 21 years or older
  3. * Smoke ≥ 5 cigarettes per day for the past year
  4. * Willing to use Oral Nicotine Pouches (ONP) or Nicotine Replacement Therapy (NRT)
  5. * Live in a rural Appalachian County
  6. * Have a smartphone and/or willing to use a smartphone for study purposes (smartphones may be provided to participants for study purposes only)
  7. * Willing to blow air into a handheld study device
  8. * If capable of becoming pregnant, verbal confirmation of not being pregnant based on urine pregnancy test results
  1. * Report currently using smoking cessation medications, NRT, or actively seeking treatment for smoking cessation
  2. * Use of ONPs in past 3 months
  3. * Use of Nicotine Replacement Therapies in past 3 months
  4. * Use of other tobacco products \> 10 days/month
  5. * Unstable or significant medical condition
  6. * Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
  7. * History of cardiac event or distress within the past 3 months
  8. * Live in same household as another study participant.
  9. * Currently pregnant, planning to become pregnant within 6 months, or breastfeeding

Contacts and Locations

Study Contact

The Ohio State University Comprehensive Cancer Center
CONTACT
800-293-5066
OSUCCCClinicaltrials@osumc.edu

Principal Investigator

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

Study Locations (Sites)

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University Comprehensive Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-13
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2025-06-13
Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Cigarette Smoking-Related Carcinoma