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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,000
Undergo carbon monoxide measurement
Use nicotine lozenge
Use oral nicotine pouch
Use nicotine patch
measurements; data gathering
Check-in phone calls to study participants
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
RECRUITINGBiochemically 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
Using linear regression analysis, adjusting for baseline nicotine dependence.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to the end of the 14 week observation phase
The Ohio State University Comprehensive Cancer Center
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