Recruiting

Oral Nicotine Pouches vs. Nicotine Replacement Therapy

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT06763536

Conditions

Cigarette Smoking-Related Carcinoma

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Carbon Monoxide Measurement

Nicotine Lozenge

Oral Nicotine Pouch

Nicotine Patch

Survey Administration

Study Details

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.

Conditions

Cigarette Smoking-Related Carcinoma

Study ID

NCT06763536

Start date

Jun 13, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Carbon Monoxide Measurement

Undergo carbon monoxide measurement

Nicotine Lozenge

Use nicotine lozenge

Oral Nicotine Pouch

Use oral nicotine pouch

Nicotine Patch

Use nicotine patch

Survey Administration

measurements; data gathering

Check-in Phone Calls

Check-in phone calls to study participants

Primary outcome measure

  • Biochemically verified 7-day point prevalence abstinence from cigarettes [ Time Frame: At the end of the 12- week switch phase ]
  • Complete switching rate (Aim 1) [ Time Frame: At the end of the 12-week switch phase ]
  • Abstinence from cigarettes (Aim 1) [ Time Frame: At the end of the 12-week switch phase ]
  • Cigarettes smoked per day (Aim 1) [ Time Frame: At the end of the 12-week switch phase ]
  • Differences in product appeal (Aim 2) [ Time Frame: From baseline to the end of the 12 week switch phase ]
  • Cigarette craving (Aim 2) [ Time Frame: Up to the end of the 12 week switch phase ]
  • Withdrawal symptoms (Aim 2) [ Time Frame: Up to the end of the 12 week switch phase ]
  • Change in nicotine dependence among participants who completely switched to their assigned study product (Aim 2) [ Time Frame: From baseline to the end of the 12 weeks switch phase ]
  • Abstinence from cigarettes (Aim 3) [ Time Frame: Up to the end of the 14 week observation phase ]
  • Number of days the study products are used (Aim 3) [ Time Frame: Up to the end of the 14 week observation phase ]
  • Purchase and continued use of the study products (Aim 3) [ Time Frame: Up to the end of the 14 week observation phase ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Brittney L. Keller-Hamilton, PhD, MPH

614-366-9652

Principal Investigator:

Brittney L. Keller-Hamilton

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-06-30.