Abstract Introduction Innovative interventions such as repetitive transcranial magnetic stimulation (rTMS) may hold promise for individuals seeking smoking cessation support. In this Phase II pilot trial, we explored the potential of low-frequency rTMS (1 Hz) combined with nicotine replacement therapy to contribute to sustained tobacco abstinence. Methods A non-comparative single-step Fleming-type Phase II randomized, double-blind, sham-controlled design was used to test the eligibility of active rTMS for a Phase III trial. The primary outcome was biochemically confirmed Continuous Abstinence Rate (CAR) at six weeks post-randomization in the active rTMS group. Secondary outcomes included 12-week and 12-month CAR, craving, mood and safety evaluations in both groups. Results 78 participants were randomized to the active (n=39) or sham rTMS group (n=39). All participants received nicotine replacement therapy. In the active rTMS group, at 6-week follow-up, 16 patients (41%) were abstinent versus 18 patients (46%) in the sham rTMS group. At the 12-week and 12-month follow-up assessments, abstinence rates declined in both groups, with 26% and 15% of participants maintaining abstinence in the active rTMS group, compared with 15% and 10% in the sham group, respectively. Craving scores decreased in both groups, and mood scores were equally distributed. Eleven mild-to-moderate adverse events were reported in the active group versus twenty-three in the sham group. Conclusion Given our definition of treatment efficacy, active low-frequency rTMS can be considered effective and eligible for a phase III trial. However, this result requires careful consideration since the sham rTMS group exhibited similar outcomes. The remaining uncertainty suggests a need for further research, particularly to assess nicotine’s influence on cortical excitability.
Demina et al. (Fri,) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: