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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT06763536
Status
Recruiting
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Conditions

  • Cigarette Smoking-Related Carcinoma

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Carbon Monoxide Measurement — OTHER
    Undergo carbon monoxide measurement
  • Nicotine Lozenge — OTHER
    Use nicotine lozenge
  • Oral Nicotine Pouch — OTHER
    Use oral nicotine pouch
  • Nicotine Patch — OTHER
    Use nicotine patch
  • Survey Administration — OTHER
    measurements; data gathering
  • Check-in Phone Calls — OTHER
    Check-in phone calls to study participants

Study Details

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.

Key Dates

Start date
Jun 13, 2025
Status verified
Jun 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Arm II (nicotine replacement therapy)
    SAMPLING PHASE: Participants receive 2 different strengths of nicotine replacement therapy patches and 2 different strengths and 3 different flavors of nicotine replacement therapy lozenges. Participants use the products ad libitum, starting with the lowest concentration, to determine their preferred concentration and flavor, over 2 weeks. SWITCH PHASE: Participants receive their preferred nicotine patches and lozenges and use them in place of cigarettes for 12 weeks. Participants complete surveys and have their carbon monoxide levels measured at various points throughout the study. OBSERVATION PHASE: After completion of intervention, participants complete a final follow-up survey, along with a carbon monoxide measure, 14 weeks after the intervention ends.
  • Experimental: Arm I (oral nicotine pouch)
    SAMPLING PHASE: Participants receive 2 concentrations of three different flavors of oral nicotine pouches. Participants use the products ad libitum, starting with the lowest concentration, to determine their preferred concentration and flavor, over 2 weeks. SWITCH PHASE: Participants receive their preferred oral nicotine pouches and use them in place of cigarettes for 12 weeks. Participants complete surveys and have their carbon monoxide levels measured at various points throughout the study. OBSERVATION PHASE: After completion of the intervention, participants complete a final follow-up survey, along with a carbon monoxide measure, 14 weeks after the intervention ends.

Primary Outcome Measure

Biochemically verified 7-day point prevalence abstinence from cigarettes [ Time Frame: At the end of the 12- week switch phase ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Brittney L. Keller-Hamilton, PhD, MPH
614-366-9652
Brittney L. Keller-Hamilton (PRINCIPAL_INVESTIGATOR)

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By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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