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.
Age range
21 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Biochemically verified 7-day point prevalence abstinence from cigarettes
Timeframe: At the end of the 12- week switch phase
Complete switching rate (Aim 1)
Timeframe: At the end of the 12-week switch phase
Abstinence from cigarettes (Aim 1)
Timeframe: At the end of the 12-week switch phase
Cigarettes smoked per day (Aim 1)
Timeframe: At the end of the 12-week switch phase
Differences in product appeal (Aim 2)
Timeframe: From baseline to the end of the 12 week switch phase
Cigarette craving (Aim 2)
Timeframe: Up to the end of the 12 week switch phase
Withdrawal symptoms (Aim 2)
Timeframe: Up to the end of the 12 week switch phase
The Ohio State University Comprehensive Cancer Center
Change in nicotine dependence among participants who completely switched to their assigned study product (Aim 2)
Timeframe: From baseline to the end of the 12 weeks switch phase
Abstinence from cigarettes (Aim 3)
Timeframe: Up to the end of the 14 week observation phase
Number of days the study products are used (Aim 3)
Timeframe: Up to the end of the 14 week observation phase
Purchase and continued use of the study products (Aim 3)
Timeframe: Up to the end of the 14 week observation phase