Nicotine Replacement for Cigarette Smoking

(Pack2Pouch+ Trial)

This trial tests new strategies for individuals who smoke cigarettes and have attempted to switch to oral nicotine pouches without fully quitting. Participants will either try stronger nicotine pouches or use a nicotine patch alongside their pouches to determine if these changes help reduce smoking. The study aims to assess the practicality and usefulness of these methods for future research. Individuals who participated in the Pack2Pouch study and continue to smoke while living in the Charleston, SC area may be suitable candidates for this trial. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, and this research seeks to understand how it benefits more patients.

Yes, you will need to stop using any smoking cessation medications to participate in this trial.

Research has shown that oral nicotine pouches are likely less harmful than traditional tobacco products like cigarettes. These pouches do not contain tobacco, the plant in cigarettes known to cause cancer. However, the FDA has not approved them as a smoking cessation method. Some studies found that people using oral nicotine pouches had lower levels of carboxyhaemoglobin, indicating less carbon monoxide exposure, compared to those who continued smoking cigarettes.

Most treatments for cigarette smoking involve nicotine replacement therapies like patches, gums, or lozenges. However, this trial is exploring oral nicotine pouches, which are unique because they offer a discreet and smokeless alternative. Researchers are excited because one arm of the trial increases the nicotine content of these pouches, potentially enhancing their effectiveness in reducing cravings. Another exciting aspect is the combination of nicotine pouches with other nicotine replacement therapies, which might provide an even more comprehensive approach to quitting smoking. These innovative methods could offer more personalized and flexible options for people looking to quit smoking.

In this trial, participants will receive either oral nicotine pouches or nicotine replacement therapy (NRT) patches. Studies suggest that oral nicotine pouches might help reduce cigarette consumption, but evidence is limited regarding their effectiveness in helping people quit smoking entirely. Some research indicates they can decrease the number of cigarettes smoked, but their impact on complete cessation remains unclear. In contrast, research has well-supported NRT patches, showing they increase the chances of quitting smoking by 50% to 70%. Combining these patches with other methods, such as oral pouches, might facilitate reducing or quitting smoking.¹³⁶⁷⁸