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

Not Applicable

Not yet recruiting

• Conditions: Cigarette Smoking-Related Carcinoma
• Interventions: Procedure: Carbon Monoxide Measurement; Other: Internet-Based Intervention; Drug: Nicotine Oral Pouch; Drug: Nicotine Lozenge; Other: Survey Administration; Drug: Nicotine Patch

• Registration Number: NCT06763536
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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 cancer disparities 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.

Detailed Description

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 3 concentrations of oral nicotine pouches. Participants use the products ad libitum, starting with the lowest concentration, to determine their preferred concentration, over 2 weeks.

SWITCH PHASE: Participants receive their chosen oral nicotine pouches and use them in place of cigarettes and receive daily check-ins via smartphone application for 12 weeks.

Participants undergo carbon monoxide measurement throughout the study.

ARM II:

SAMPLING PHASE: Participants receive 2 different strengths of patches and 2 different strengths and 4 different flavors of 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 chosen nicotine patches and lozenges and use them in place of cigarettes and receive daily check-ins via smartphone application for 12 weeks.

Participants undergo carbon monoxide measurement throughout the study.

After completion of study treatment, patients are followed up every 4 weeks for 14 weeks.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-02
• Last Update Submitted: 2025-01-02
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-08
• Study Start: 2025-03-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Read and speak English
• 21 years or older
• Smoke ≥ 5 cigarettes per day for the past year
• Willing to use and report at least minimal interest in switching to ONPs or NRT (> "not at all" on a Likert scale)
• Live in 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)
• Negative pregnancy test produced if capable of becoming pregnant

Read More

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 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
• Currently pregnant, planning to become pregnant within 6 months, or breastfeeding

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (oral nicotine pouch)	Carbon Monoxide Measurement	SAMPLING PHASE: Participants receive 3 concentrations of oral nicotine pouches. Participants use the products ad libitum, starting with the lowest concentration, to determine their preferred concentration, over 2 weeks. SWITCH PHASE: Participants receive their chosen oral nicotine pouches and use them in place of cigarettes and receive daily check-ins via smartphone application for 12 weeks. Participants undergo carbon monoxide measurement throughout the study.
Arm I (oral nicotine pouch)	Internet-Based Intervention	SAMPLING PHASE: Participants receive 3 concentrations of oral nicotine pouches. Participants use the products ad libitum, starting with the lowest concentration, to determine their preferred concentration, over 2 weeks. SWITCH PHASE: Participants receive their chosen oral nicotine pouches and use them in place of cigarettes and receive daily check-ins via smartphone application for 12 weeks. Participants undergo carbon monoxide measurement throughout the study.
Arm I (oral nicotine pouch)	Nicotine Oral Pouch	SAMPLING PHASE: Participants receive 3 concentrations of oral nicotine pouches. Participants use the products ad libitum, starting with the lowest concentration, to determine their preferred concentration, over 2 weeks. SWITCH PHASE: Participants receive their chosen oral nicotine pouches and use them in place of cigarettes and receive daily check-ins via smartphone application for 12 weeks. Participants undergo carbon monoxide measurement throughout the study.
Arm I (oral nicotine pouch)	Survey Administration	SAMPLING PHASE: Participants receive 3 concentrations of oral nicotine pouches. Participants use the products ad libitum, starting with the lowest concentration, to determine their preferred concentration, over 2 weeks. SWITCH PHASE: Participants receive their chosen oral nicotine pouches and use them in place of cigarettes and receive daily check-ins via smartphone application for 12 weeks. Participants undergo carbon monoxide measurement throughout the study.
Arm II (nicotine replacement therapy)	Carbon Monoxide Measurement	SAMPLING PHASE: Participants receive 2 different strengths of patches and 2 different strengths and 4 different flavors of 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 chosen nicotine patches and lozenges and use them in place of cigarettes and receive daily check-ins via smartphone application for 12 weeks. Participants undergo carbon monoxide measurement throughout the study.
Arm II (nicotine replacement therapy)	Internet-Based Intervention	SAMPLING PHASE: Participants receive 2 different strengths of patches and 2 different strengths and 4 different flavors of 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 chosen nicotine patches and lozenges and use them in place of cigarettes and receive daily check-ins via smartphone application for 12 weeks. Participants undergo carbon monoxide measurement throughout the study.
Arm II (nicotine replacement therapy)	Nicotine Lozenge	SAMPLING PHASE: Participants receive 2 different strengths of patches and 2 different strengths and 4 different flavors of 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 chosen nicotine patches and lozenges and use them in place of cigarettes and receive daily check-ins via smartphone application for 12 weeks. Participants undergo carbon monoxide measurement throughout the study.
Arm II (nicotine replacement therapy)	Nicotine Patch	SAMPLING PHASE: Participants receive 2 different strengths of patches and 2 different strengths and 4 different flavors of 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 chosen nicotine patches and lozenges and use them in place of cigarettes and receive daily check-ins via smartphone application for 12 weeks. Participants undergo carbon monoxide measurement throughout the study.
Arm II (nicotine replacement therapy)	Survey Administration	SAMPLING PHASE: Participants receive 2 different strengths of patches and 2 different strengths and 4 different flavors of 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 chosen nicotine patches and lozenges and use them in place of cigarettes and receive daily check-ins via smartphone application for 12 weeks. Participants undergo carbon monoxide measurement throughout the study.

Primary Outcome Measures

Name	Time	Method
Biochemically verified 7-day point prevalence abstinence from cigarettes	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.
Complete switching rate (Aim 1)	At the end of the 12-week switch phase	Will be compared between arms using logistic regression analysis, adjusting for baseline variables as needed.
Abstinence from cigarettes (Aim 1)	At the end of the 12-week switch phase	Will be compared between arms using logistic regression analysis, adjusting for baseline variables as needed.
Cigarettes smoked per day (Aim 1)	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.
Differences in product appeal (Aim 2)	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.
Cigarette craving (Aim 2)	Up to the end of the 12 week switch phase	Will be evaluated with linear regression models adjusting for appropriate confounders.
Withdrawal symptoms (Aim 2)	Up to the end of the 12 week switch phase	Will be evaluated with linear regression models adjusting for appropriate confounders.
Change in nicotine dependence among participants who completely switched to their assigned study product (Aim 2)	From baseline to the end of the 12 weeks switch phase	Using linear regression analysis, adjusting for baseline nicotine dependence.
Abstinence from cigarettes (Aim 3)	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.
Number of days the study products are used (Aim 3)	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.
Purchase and continued use of the study products (Aim 3)	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.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States