Varenicline + Nicotine Lozenges for Smoking Cessation

(COMBOII Trial)

This trial seeks to find the best way to quit smoking by testing a combination of varenicline, a prescription drug that reduces cravings and withdrawal symptoms, and nicotine lozenges. It examines the effectiveness of these treatments when paired with smartphone apps that remind users to take their medication. The trial targets individuals who smoke at least five cigarettes a day and are ready to quit soon. It aims to determine if adding nicotine lozenges and smartphone reminders makes quitting easier and more successful. Participants will receive support calls and must commit to the program for about six months. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

The trial information does not specify if you need to stop taking your current medications. However, you must be willing to use varenicline and nicotine lozenges during the study.

Research has shown that varenicline is generally safe for most adults who want to quit smoking. In several studies, nausea was the most common side effect, affecting about 28% of people. Headaches were reported by around 15.5% of participants. Importantly, large studies found no increased risk of serious heart problems or death from using varenicline.

There is limited data on using varenicline with nicotine lozenges. However, varenicline is already approved for use on its own, suggesting its safety. The FDA even removed a previous warning about varenicline, indicating confidence in its safety.

Researchers are excited about these smoking cessation treatments because they combine varenicline, a widely used smoking cessation aid, with nicotine lozenges and innovative smartphone interventions. Varenicline itself is known for reducing cravings and withdrawal symptoms, but these trial treatments take it a step further by incorporating a digital adherence component. Unlike traditional methods, which may rely solely on medication or counseling, these treatments use smartphone technology to enhance adherence and provide personalized support. This approach could potentially increase the success rates of quitting smoking by making it easier for participants to stick to their treatment plan and access support whenever they need it.

Research has shown that varenicline effectively helps people stop smoking. Studies indicate it significantly increases the chances of quitting compared to no treatment. In this trial, some participants will receive varenicline along with nicotine replacement products, such as lozenges, which might further enhance long-term success. A review of several studies found that combining treatments works better than using just one. Additionally, some participants will receive a smartphone-based intervention. Early results suggest that smartphone reminders could help people remember to take their medication, potentially improving quit rates.⁶⁷⁸⁹¹⁰