Testing Oral Nicotine Pouches to Reduce Smoking-Related Cancer in Rural Appalachia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Biochemically verified 7-day point prevalence abstinence from cigarettes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Carbon Monoxide Measurement (Other)
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.
干预措施: Oral Nicotine Pouch (Other)
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.
干预措施: Survey Administration (Other)
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.
干预措施: Check-in Phone Calls (Other)
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.
干预措施: Carbon Monoxide Measurement (Other)
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.
干预措施: Check-in Phone Calls (Other)
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.
干预措施: Survey Administration (Other)
结局指标
主要结局
Biochemically verified 7-day point prevalence abstinence from cigarettes
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
Brittney Keller-Hamilton
Principal Investigator
Ohio State University Comprehensive Cancer Center