Comparing Oral Nicotine Pouches and Nicotine Replacement Therapy to Reduce Cigarette Smoking in Adults from Rural Appalachia

What this Trial Is About

This clinical trial focuses on adults living in rural Appalachia who smoke cigarettes and aims to compare the effects of oral nicotine pouches with nicotine replacement therapy patches and lozenges on reducing cigarette use. The study is motivated by the high rates of lung and oral cancers in Appalachia linked to smoking, seeking new ways to lower cancer risk through alternative nicotine products. Participants are randomly assigned to one of two groups. One group tries different flavors and strengths of oral nicotine pouches over two weeks to find their preferred option, then uses these pouches instead of cigarettes for 12 weeks. The other group follows a similar process using nicotine patches and lozenges. After the 12-week period of switching from cigarettes, participants complete a follow-up phase lasting 14 weeks, where they continue to be observed without intervention. Throughout the trial, participants complete surveys and have their carbon monoxide levels measured to monitor smoking behavior and product use. Researchers assess changes in cigarette use, cravings, withdrawal symptoms, product appeal, and nicotine dependence during the study and follow-up. The total participation includes the initial product sampling, a 12-week switch phase, and a 14-week observation period after the intervention ends.

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