Study of Low and High Nicotine Tobacco-Free Oral Pouches to Help Adults Stop Smoking Cigarettes

What this Trial Is About

This research aims to evaluate tobacco-free oral nicotine pouches TFNPs as a less harmful alternative to cigarette smoking for adults who smoke. The study compares the effects of nicotine pouches with two different nicotine levels high 6 mg and low 3 mg to see how well they help people switch from cigarettes. Researchers will also examine changes in smoking habits, biomarkers of harm, nicotine dependence, and user experience. Participants who smoke cigarettes will be randomly assigned to receive either high-dose or low-dose nicotine pouches for 5 weeks. Those smoking 5 to 20 cigarettes daily will receive one tin per day, and heavier smokers will receive two tins per day. During this period, participants are asked to switch from cigarettes to using the nicotine pouches. The study includes two in-person visits to collect biological samples and behavioral data. Throughout the study, participants will answer questions about their tobacco use and provide breath and cheek swab samples to monitor exposure and effects. Researchers will measure outcomes such as complete switching from cigarettes, reduction in smoking, and use of the nicotine pouches at 28 and 56 days. Follow-up visits include assessments one month after pouch use ends. The total participation includes sampling, monitoring, and follow-up over several weeks to assess changes and safety.

Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches