A randomized controlled trial of intermittent theta burst stimulation to the medial prefrontal cortex for tobacco use disorder: Clinical efficacy and safety.

Objective: This study aimed to evaluate the clinical efficacy and safety of administering intermittent theta burst stimulation (iTBS) to the medial prefrontal cortex for tobacco use disorder.
Methods: A randomized sham-controlled trial was conducted, with 38 participants receiving 28 sessions of active (n=25) or sham (n=13) iTBS (2 sessions/day, 600 pulses/session, 110% resting motor threshold, AFz target) along with smoking cessation education (Forever Free © booklets) over 14 visits. Primary outcomes included self-reported cigarette consumption and abstinence, verified by urinary cotinine tests. Secondary outcomes included symptoms of tobacco use disorder, negative mood, and safety/tolerability.
Results: Both active and sham groups reported reduced cigarette consumption (β = -0.12, p = 0.015), cigarette craving (β = -0.16, p = 0.002), and tobacco withdrawal symptoms (β = -0.05, p < 0.001). However, there were no significant time x group interaction effects for any measure. Similarly, the two groups had no significant differences in urinary cotinine-verified abstinence. Adverse events occurred with similar frequency in both groups.
Conclusion: There were no differences in cigarette consumption between the active and sham iTBS groups, both groups decreased cigarette consumption similarly. Further research is needed to compare iTBS to standard high-frequency rTMS and explore the potential differences in efficacy. Despite limitations, this study contributes to experimental design considerations for TMS as a novel intervention for tobacco and other substance use disorders, emphasizing the need for a more comprehensive understanding of the stimulation parameters and target sites.
Competing Interests: Declaration of Competing Interest This NIH project was originally awarded to Drs. Colleen Hanlon and Warren Bickel (Multiple Principal Investigator). After the completion of data collection, Dr. Hanlon’s role as Principal Investigator was transferred to Dr. Merideth Addicott. Colleen Hanlon is employed by BrainsWay and has financial interest in the company. The remaining authors declare no competing interests.
(Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)