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NCT Number: NCT06763536

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

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.

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Key information

Conditions

Cigarette Smoking-Related Carcinoma

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Brittney L. Keller-Hamilton

PRINCIPAL_INVESTIGATOR

Brittney L. Keller-Hamilton, PhD, MPH

CONTACT

614-366-9652

About this study

PRIMARY OBJECTIVES:

I. Evaluate short-term changes in cigarette smoking patterns, including switching, abstinence from cigarettes, and frequency of smoking between oral nicotine patches (ONPs) and NRT.

II. Compare product appeal, craving, withdrawal relief, and perceived cigarette dependence between ONPs and NRT.

III. Examine sustained changes in tobacco use behaviors, including abstinence from cigarettes, purchase of ONPs/NRT, and continued use of ONPs/NRT.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I:

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.

ARM II:

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbon Monoxide Measurement

Other

Undergo carbon monoxide measurement

Other names: Carbon Monoxide, Covita iCOquit

Nicotine lozenge

Other

Use nicotine lozenge

Other names: Rugby, Nicotine Replacement Therapy

Oral Nicotine Pouch

Other

Use oral nicotine pouch

Other names: ZYN

Nicotine patch

Other

Use nicotine patch

Other names: Rugby, Nicotine Skin Patch, Nicotine Transdermal Patch, Nicotine Replacement Therapy

Survey Administration

Other

measurements; data gathering

Check-in Phone Calls

Other

Check-in phone calls to study participants

Primary outcomes

  1. Biochemically verified 7-day point prevalence abstinence from cigarettes

    Time frame: At the end of the 12- week switch phase

    Statistical analyses will be performed using SAS 9.4. P-values less than 0.05 will be considered statistically significant. Will be presented as frequencies and proportions and compared with chi-squared tests.

  2. Complete switching rate (Aim 1)

    Time frame: At the end of the 12-week switch phase

    Will be compared between arms using logistic regression analysis, adjusting for baseline variables as needed.

  3. Abstinence from cigarettes (Aim 1)

    Time frame: At the end of the 12-week switch phase

    Will be compared between arms using logistic regression analysis, adjusting for baseline variables as needed.

  4. Cigarettes smoked per day (Aim 1)

    Time frame: At the end of the 12-week switch phase

    If needed, will apply a normalizing transformation to the number of cigarettes smoked per day (e.g., taking the logarithm) before proceeding with the analysis as a means of removing the effects of potential outliers. Will compare cigarettes smoked per day between the two arms using linear regression analysis. The model will adjust for cigarettes smoked per day at baseline and other baseline variables if they are imbalanced.

  5. Differences in product appeal (Aim 2)

    Time frame: From baseline to the end of the 12 week switch phase

    Will be adjusted for potential confounders including baseline variables such as age, gender, number of cigarettes smoked per day, and/or randomization stratification factors as necessary; normalizing transformations will be employed if needed.

  6. Cigarette craving (Aim 2)

    Time frame: Up to the end of the 12 week switch phase

    Will be evaluated with linear regression models adjusting for appropriate confounders.

  7. Withdrawal symptoms (Aim 2)

    Time frame: Up to the end of the 12 week switch phase

    Will be evaluated with linear regression models adjusting for appropriate confounders.

  8. 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

    Using linear regression analysis, adjusting for baseline nicotine dependence.

  9. Abstinence from cigarettes (Aim 3)

    Time frame: Up to the end of the 14 week observation phase

    Will be compared between arms using logistic regression analysis and will be evaluated with a logistic regression model.

  10. Number of days the study products are used (Aim 3)

    Time frame: Up to the end of the 14 week observation phase

    Linear regression analysis will be used to compare the number of days the products are used. A normalizing transformation will be employed if needed and appropriate baseline characteristics will be adjusted for.

  11. Purchase and continued use of the study products (Aim 3)

    Time frame: Up to the end of the 14 week observation phase

    Will be compared between the arms with logistic regression analysis, adjusting for all appropriate confounders.

Study contacts

Contact information is provided by the study sponsor or research team.

The Ohio State University Comprehensive Cancer Center

CONTACT

[email protected]

800-293-5066

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: ARISE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 8, 2025
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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