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

NCT06763536 | Recruiting DMC

• 3 other identifiers: 2024C0064NCI-2024-09181R01CA289551-01
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (11)

• Biochemically verified 7-day point prevalence abstinence from cigarettes

  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.

  At the end of the 12- week switch phase

• Complete switching rate (Aim 1)

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

  At the end of the 12-week switch phase

• Abstinence from cigarettes (Aim 1)

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

  At the end of the 12-week switch phase

• Cigarettes smoked per day (Aim 1)

  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.

  At the end of the 12-week switch phase

• Differences in product appeal (Aim 2)

  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.

  From baseline to the end of the 12 week switch phase

• Cigarette craving (Aim 2)

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

  Up to the end of the 12 week switch phase

• Withdrawal symptoms (Aim 2)

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

  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)

  Using linear regression analysis, adjusting for baseline nicotine dependence.

  From baseline to the end of the 12 weeks switch phase

• Abstinence from cigarettes (Aim 3)

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

  Up to the end of the 14 week observation phase

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

  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.

  Up to the end of the 14 week observation phase

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

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

  Up to the end of the 14 week observation phase

Study Arms (2)

Arm I (oral nicotine pouch)

EXPERIMENTAL

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.

Other: Carbon Monoxide Measurement; Other: Oral Nicotine Pouch; Other: Survey Administration; Other: Check-in Phone Calls

Arm II (nicotine replacement therapy)

ACTIVE COMPARATOR

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.

Other: Carbon Monoxide Measurement; Other: Nicotine Lozenge; Other: Nicotine Patch; Other: Survey Administration; Other: Check-in Phone Calls

Interventions

Carbon Monoxide Measurement OTHER

Undergo carbon monoxide measurement

Also known as: Carbon Monoxide, Covita iCOquit

Arm I (oral nicotine pouch); Arm II (nicotine replacement therapy)

Nicotine Lozenge OTHER

Use nicotine lozenge

Also known as: Rugby, Nicotine Replacement Therapy

Arm II (nicotine replacement therapy)

Oral Nicotine Pouch OTHER

Use oral nicotine pouch

Also known as: ZYN

Arm I (oral nicotine pouch)

Nicotine Patch OTHER

Use nicotine patch

Also known as: Rugby, Nicotine Skin Patch, Nicotine Transdermal Patch, Nicotine Replacement Therapy

Arm II (nicotine replacement therapy)

Survey Administration OTHER

measurements; data gathering

Arm I (oral nicotine pouch); Arm II (nicotine replacement therapy)

Check-in Phone Calls OTHER

Check-in phone calls to study participants

Arm I (oral nicotine pouch); Arm II (nicotine replacement therapy)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Read and speak English
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (1)

• Wermert A, Brasky TM, Newton AM, Hinton A, Curran H, Ferketich AK, Carpenter MJ, Shields PG, Tomko P, Wagener TL, Keller-Hamilton B. Testing oral nicotine pouches versus nicotine replacement therapy for cigarette harm reduction in Appalachia: The ARISE study protocol. PLoS One. 2025 Dec 23;20(12):e0338503. doi: 10.1371/journal.pone.0338503. eCollection 2025.

  PMID: 41433314 DERIVED

Related Links

• The Jamesline

MeSH Terms

Interventions

Carbon Monoxide; Tobacco Use Cessation Devices; albumin Rugby Park; Nicotine Replacement Therapy

Intervention Hierarchy (Ancestors)

Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds; Therapeutics; Drug Therapy

Study Officials

• Brittney L Keller-Hamilton, PhD, MPH

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: June 13, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

US (1)