Vagal Nerve Stimulation + Nicotine Replacement for Smoking Cessation

This trial aims to determine if combining vagal nerve stimulation (a device that sends mild electrical signals to a nerve in the neck) with nicotine patches, a form of nicotine replacement therapy, can help people quit smoking more effectively. Participants will use either both the nerve stimulator and nicotine patches or just the nicotine patches for 12 weeks, along with a self-help guide. This trial suits individuals who smoke at least 10 cigarettes a day and are motivated to quit. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to developing a potentially effective smoking cessation method.

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using medications that interact with varenicline. It's best to discuss your current medications with the study team.

Research has shown that vagal nerve stimulation (VNS) is generally easy for people to handle. The FDA has approved a type of VNS for treating opioid withdrawal, indicating its safety. Another study on a non-invasive form of VNS for vaping found it worked quickly and had only minor side effects, further supporting its safety.

Safety information for nicotine replacement therapy (NRT), such as nicotine patches, is well-known. The FDA has already approved NRT to help people quit smoking, and it is generally considered safe. Side effects are usually mild, such as skin irritation at the patch site.

Researchers are excited about the combination of vagal nerve stimulation (VNS) with nicotine replacement therapy (NRT) for smoking cessation because it introduces a new way to support quitting efforts. While standard treatments like nicotine patches, gum, or lozenges primarily focus on reducing withdrawal symptoms by replacing nicotine, VNS works differently by potentially modulating neural circuits related to addiction and craving. This dual approach not only addresses the physical dependence with nicotine patches but also aims to reduce cravings and improve mental resilience through VNS, offering a comprehensive solution that could enhance the chances of successfully quitting smoking.

Research has shown that combining vagal nerve stimulation (VNS) with nicotine replacement therapy (NRT) can help people quit smoking. In this trial, one group will receive both VNS and NRT, potentially increasing the chances of remaining smoke-free by managing withdrawal symptoms and easing the quitting process. VNS sends gentle electrical signals to the brain, reducing cravings and stress associated with smoking. Previous patients demonstrated that VNS can alleviate anxiety linked to addiction, which might assist in breaking the addiction cycle. Overall, this method is considered a potential aid for those wanting to stop smoking.³⁴⁵⁶⁷