Nicotine Pouches vs Replacement Therapy for Cancer Risk Reduction

(ARISE Trial)

This trial aims to determine if oral nicotine pouches or traditional nicotine replacement therapies, such as patches and lozenges, can help reduce cigarette use among smokers in rural Appalachia. By testing these methods, researchers aim to find effective ways to lower the risk of lung and oral cancers linked to smoking in this region. Smokers living in rural Appalachian counties who smoke at least five cigarettes a day and are willing to try these alternative nicotine products may be suitable candidates for this study. As an unphased trial, participants have the opportunity to contribute to groundbreaking research that could lead to new smoking cessation strategies.

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using smoking cessation medications or nicotine replacement therapies.

Research has shown that oral nicotine pouches might expose users to fewer harmful chemicals than smoking cigarettes. However, they are not completely risk-free. Some users have reported oral health issues, but data on this remains limited. In one study, over 40% of nicotine pouch users quit smoking, suggesting potential benefits for some individuals.

Nicotine replacement therapies, such as patches and lozenges, are generally well-tolerated and have been used for years to aid smoking cessation. Most people find them safe, though some may experience mild side effects, like skin irritation from patches or a sore mouth from lozenges. These side effects are usually not serious.

Researchers are excited about these treatments because they offer new ways to reduce cancer risk for smokers. Unlike traditional nicotine replacement therapies, which often involve patches and lozenges, oral nicotine pouches provide a discreet and smoke-free way to manage nicotine cravings. This method allows users to choose their preferred concentration and flavor, potentially improving adherence and satisfaction. Furthermore, using these pouches in place of cigarettes could significantly lower exposure to harmful chemicals found in cigarette smoke, thereby reducing cancer risk more effectively. These innovations could make quitting smoking easier and more appealing for many, promising a healthier option for those seeking to reduce their cancer risk.

This trial will compare oral nicotine pouches with nicotine replacement therapies, such as patches and lozenges, to reduce cigarette use. Studies have shown that oral nicotine pouches can help people smoke fewer cigarettes over a short period, like 4 weeks, but they do not seem to reduce the harm caused by tobacco. Participants in this trial may receive oral nicotine pouches to assess their effectiveness. In contrast, nicotine replacement therapies, like patches and lozenges, have been found to help people quit using smokeless tobacco products. Participants in another arm of this trial will receive nicotine replacement therapies. Both treatments aim to reduce cigarette use, a major risk factor for lung and mouth cancers in rural Appalachia. More research is needed to understand the long-term effectiveness of these methods for smoking reduction.²⁶⁷⁸⁹