Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation method increasingly used to treat psychiatric disorders, primarily depression. Initial studies suggest that rTMS may help to treat addictions, but evaluation in multicenter randomized controlled trials (RCTs) is needed. We conducted a multicenter double-blind RCT in 262 chronic smokers meeting DSM-5 criteria for tobacco use disorder, who had made at least one prior failed attempt to quit, with 68% having made at least three failed attempts. They received three weeks of daily bilat­eral active or sham rTMS to the lateral prefrontal and insular cortices, followed by once weekly rTMS for three weeks. Each rTMS session was administered following a cue-induced craving procedure, and participants were monitored for a total of six weeks. Those in abstinence were monitored for additional 12 weeks. The primary outcome measure was the four-week continuous quit rate (CQR) until Week 18 in the intent-to-treat efficacy set, as determined by daily smoking diaries and verified by urine cotinine measures. The trial was registered at ClinicalTrials.gov (NCT02126124). In the intent-to-treat analysis set (N=234), the CQR until Week 18 was 19.4% following active and 8.7% following sham rTMS (X²=5.655, p=0.017). Among completers (N=169), the CQR until Week 18 was 28.0% and 11.7%, respectively (X²=7.219, p=0.007). The reduction in cigarette consumption and craving was significantly greater in the active than the sham group as early as two weeks into treatment. This study establishes a safe treatment protocol that promotes smoking cessation by stimulating relevant brain circuits. It represents the first large multicenter RCT of brain stimulation in addiction medicine, and has led to the first clearance by the US Food and Drug Administration for rTMS as an aid in smok­ing cessation for adults.

中文翻译：

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重复经颅磁刺激戒烟：一项关键的多中心双盲随机对照试验

重复经颅磁刺激 (rTMS) 是一种非侵入性脑刺激方法，越来越多地用于治疗精神疾病，主要是抑郁症。初步研究表明 rTMS 可能有助于治疗成瘾，但需要在多中心随机对照试验 (RCT) 中进行评估。我们对 262 名符合 DSM-5 烟草使用障碍标准的长期吸烟者进行了一项多中心双盲 RCT，这些人之前至少尝试过一次戒烟失败，其中 68% 的人至少尝试过 3 次失败。他们每天接受三周的双侧前额叶和岛叶皮质的每日双侧主动或假 rTMS，然后是每周一次的 rTMS，持续三周。每个 rTMS 会话都按照提示诱导的渴望程序进行管理，参与者总共接受了六周的监测。那些禁欲的人还要再监测 12 周。主要结局指标是意向治疗有效性组中直至第 18 周的 4 周连续戒烟率 (CQR)，由每日吸烟日记确定并通过尿液可替宁指标验证。该试验在 ClinicalTrials.gov (NCT02126124) 上注册。在意向治疗分析组 (N=234) 中，直到第 18 周的 CQR 在活动后为 19.4%，在假 rTMS 后为 8.7%（X² = 5.655，p = 0.017）。在完成者中（N=169），直到第 18 周的 CQR 分别为 28.0% 和 11.7%（X ² =7.219，p=0.007）。早在治疗开始两周后，主动组的香烟消耗量和渴望的减少就明显大于假组。这项研究建立了一个安全的治疗方案，通过刺激相关的大脑回路来促进戒烟。它代表了成瘾医学中第一个大型多中心脑刺激 RCT，并已导致美国食品和药物管理局首次批准 rTMS 作为成人戒烟的辅助手段。