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

Ohio State University Comprehensive Cancer Center · with National Cancer Institute (NCI) · NCT06763536

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 21+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
1000
US sites recruiting
1
Study start
June 13, 2025
Record last updated
June 30, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Carbon Monoxide Measurement; Nicotine Lozenge; Oral Nicotine Pouch; Nicotine Patch; Survey Administration; Check-in Phone Calls

Conditions: Cigarette Smoking-Related Carcinoma

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Ohio State University Comprehensive Cancer Center

    Columbus, OH 43210

    Site contact: Brittney L. Keller-Hamilton, PhD, MPH · 614-366-9652

Study contacts (from the official record)

  • The Ohio State University Comprehensive Cancer Center · 800-293-5066 · OSUCCCClinicaltrials@osumc.edu
All smoking & vaping studies in Ohio →
Oral Nicotine Pouches Versus Nicotine Replacement Therapy to… (NCT06763536) | Bored Studies