Varenicline + TMS for Nicotine Addiction

(V-TMS Trial)

This trial aims to determine if combining varenicline, a medication that aids in quitting nicotine, with Transcranial Magnetic Stimulation (TMS), a non-invasive treatment using magnetic fields, effectively helps adults stop using nicotine products. Researchers will compare the effects of active TMS with a sham (inactive) TMS to assess whether the active treatment better reduces cravings and increases abstinence. Individuals who have used nicotine daily for at least the past 90 days and wish to quit within the next month may be suitable for this study. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand its benefits for more patients.

The trial does not specify if you need to stop taking your current medications, but you cannot use other smoking cessation aids during the study. It's best to discuss your current medications with the study team to ensure they don't interfere with the trial.

Research has shown that both varenicline and Transcranial Magnetic Stimulation (TMS) have been studied for safety in people trying to quit smoking. Varenicline, a medication generally well-tolerated, may cause nausea, trouble sleeping, or unusual dreams in some users. The FDA has approved it for smoking cessation, confirming its safety through testing.

For TMS, studies have found it is usually safe for quitting smoking, with headaches as the most common side effect. No seizures have been reported in these studies, indicating good safety. This treatment uses magnetic fields to stimulate certain brain areas and appears effective without serious problems.

Researchers are excited about the combination of Varenicline and Transcranial Magnetic Stimulation (TMS) for tackling nicotine addiction. Unlike traditional treatments that focus solely on medication or counseling, this approach combines the proven effectiveness of Varenicline—a medication that reduces cravings and withdrawal symptoms—with TMS, a non-invasive technique that uses magnetic fields to stimulate specific areas of the brain linked to addiction. This dual-action strategy has the potential to enhance the success rates of smoking cessation by targeting both the physiological and neurological aspects of addiction. Moreover, TMS is tailored to each individual based on their brain MRI, potentially leading to more personalized and effective treatment outcomes.

Studies have shown that varenicline is the most effective medication for quitting smoking compared to options like nicotine patches or gum. It targets brain receptors to reduce cravings and withdrawal symptoms. In this trial, participants will receive varenicline alongside either active or sham Transcranial Magnetic Stimulation (TMS). Research indicates that TMS, a non-invasive brain treatment, can help people quit smoking by reducing nicotine cravings and the number of cigarettes smoked each day. When used together, these treatments might be even more effective at increasing quit rates and reducing cravings. Early studies found that high-frequency TMS combined with smoking cues significantly improved the chances of quitting. This combination shows promise for those looking to quit nicotine for good.⁶⁷⁸⁹¹⁰