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Background:
Current treatments for smoking cessation face limitations in terms of efficacy, particularly in achieving sustained abstinence. A substantial body of evidence points to the involvement of the insula in nicotine addiction.
Objective:
This study aimed to assess the effectiveness of bilateral repetitive transcranial magnetic stimulation (rTMS) targeted at the insular cortex with the H11 coil, in comparison to sham stimulation, in promoting smoking abstinence and influencing smoking outcomes among individuals undergoing standard varenicline treatment.
Methods:
In this randomized, double-blind, sham-controlled trial, 42 participants were enrolled and randomly assigned to receive either active (n = 24) or sham (n = 18) high-frequency rTMS directed at the insula over a period of 4 weeks, concurrently with varenicline treatment lasting for 12 weeks. The primary outcome was 7-day point prevalence abstinence at the conclusion of the 12 weeks.
Results:
At the end of the treatment period (Week 12), participants in the active group exhibited significantly higher abstinence rates compared to those in the sham group (82.4% vs. 30.7%, p = 0.013). Secondary outcome measures, including abstinence rates at the end of rTMS treatment (Week 4), abstinence rates at 6 months, and smoking-related outcomes (e.g., craving, withdrawal), did not show significant differences between the two groups. No disparities in reported adverse events were observed between the active and sham groups.
Conclusions:
This study suggests the potential benefits of a combined approach for smoking cessation, involving insula rTMS with the H11 coil in conjunction with varenicline. The consideration of maintenance rTMS sessions and continued varenicline for those in abstinence may contribute to longer-term effects and warrants exploration in future studies.