PDF(Pubmed)
Abstract：
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.
CONCLUSIONS: 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.
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.
CONCLUSIONS: 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.
摘要：
目的：本研究旨在评估对内侧前额叶皮质给予间歇性θ爆发刺激（iTBS）治疗烟草使用障碍的临床疗效和安全性。
方法：进行一项随机假对照试验，38名参与者接受28次活动(n=25)或假(n=13)iTBS(2次/天，600脉冲/会话，110%静止运动阈值,AFz目标）以及戒烟教育（永远免费©小册子）超过14次访问。主要结果包括自我报告的香烟消费和禁欲，通过尿可替宁试验验证。次要结果包括烟草使用障碍的症状，负面情绪,和安全性/耐受性。
结果：活动组和假手术组均报告香烟消耗量减少（β=-0.12，p=0.015），香烟渴望（β=-0.16，p=0.002），和烟草戒断症状（β=-0.05，p<0.001）。然而,任何测量均无显著的时间X组交互作用.同样，两组在尿可替宁验证的禁欲方面没有显著差异.两组不良事件发生频率相似。
结论：有活性的和假的iTBS组之间的香烟消费没有差异，两组均减少了卷烟消费量。需要进一步的研究来比较iTBS与标准高频rTMS，并探索疗效的潜在差异。尽管有局限性,这项研究有助于TMS作为烟草和其他物质使用障碍的新型干预措施的实验设计考虑，强调需要更全面地了解刺激参数和目标部位。
方法：进行一项随机假对照试验，38名参与者接受28次活动(n=25)或假(n=13)iTBS(2次/天，600脉冲/会话，110%静止运动阈值,AFz目标）以及戒烟教育（永远免费©小册子）超过14次访问。主要结果包括自我报告的香烟消费和禁欲，通过尿可替宁试验验证。次要结果包括烟草使用障碍的症状，负面情绪,和安全性/耐受性。
结果：活动组和假手术组均报告香烟消耗量减少（β=-0.12，p=0.015），香烟渴望（β=-0.16，p=0.002），和烟草戒断症状（β=-0.05，p<0.001）。然而,任何测量均无显著的时间X组交互作用.同样，两组在尿可替宁验证的禁欲方面没有显著差异.两组不良事件发生频率相似。
结论：有活性的和假的iTBS组之间的香烟消费没有差异，两组均减少了卷烟消费量。需要进一步的研究来比较iTBS与标准高频rTMS，并探索疗效的潜在差异。尽管有局限性,这项研究有助于TMS作为烟草和其他物质使用障碍的新型干预措施的实验设计考虑，强调需要更全面地了解刺激参数和目标部位。
