Department of Biomedical, Experimental and Clinical Sciences "Mario Serio", Department of Neuroscience, Psychology, Drug Research and Child Health NEUROFARBA, Department of Health Sciences DSS, Università degli Studi di Firenze, Florence, Italy.
Azienda Ospedaliera Universitaria di Careggi, Neurophysiology Unit, Firenze, Italy.
PLoS One. 2021 Nov 16;16(11):e0259860. doi: 10.1371/journal.pone.0259860. eCollection 2021.
BACKGROUND: Cocaine use disorder (CUD) is a global health issue with no effective treatment. Repetitive Transcranial Magnetic Stimulation (rTMS) is a recently proposed therapy for CUD. METHODS: We conducted a single-center, randomised, sham-controlled, blinded, parallel-group research with patients randomly allocated to rTMS (15 Hz) or Sham group (1:1) using a computerised block randomisation process. We enrolled 62 of 81 CUD patients in two years. Patients were followed for eight weeks after receiving 15 15 Hz rTMS/sham sessions over the left dorsolateral prefrontal cortex (DLPFC) during the first three weeks of the study. We targeted the DLFPC following the 5 cm method. Cocaine lapses in twice a week urine tests were the primary outcome. The secondary outcomes were craving severity, cocaine use pattern, and psychometric assessments. FINDINGS: We randomly allocated patients to either an active rTMS group (32 subjects) or a sham treatment group (30 subjects). Thirteen (42%) and twelve (43.3%) of the subjects in rTMS and sham groups, respectively, completed the full trial regimen, displaying a high dropout rate. Ten/30 (33%) of rTMS-treated patients tested negative for cocaine in urine, in contrast to 4/27 of placebo controls (p = 0.18, odd ratio 2.88, CI 0.9-10). The Kaplan-Meier survival curve did not state a significant change between the treated and sham groups in the time of cocaine urine negativisation (p = 0.20). However, the severity of cocaine-related cues mediated craving (VAS peak) was substantially decreased in the rTMS treated group (p<0.03) after treatment at T1, corresponding to the end of rTMS treatment. Furthermore, in the rTMS and sham groups, self-reported days of cocaine use decreased significantly (p<0.03). Finally, psychometric impulsivity parameters improved in rTMS-treated patients, while depression scales improved in both groups. CONCLUSIONS: In CUD, rTMS could be a useful tool for lowering cocaine craving and consumption. TRIAL REGISTRATION: The study number on clinicalTrials.gov is NCT03607591.
背景：可卡因使用障碍（CUD）是一个全球性的健康问题，目前尚无有效的治疗方法。重复经颅磁刺激（rTMS）是一种最近提出的 CUD 治疗方法。
方法：我们进行了一项单中心、随机、假对照、盲法、平行组研究，将患者随机分配到 rTMS（15 Hz）或假治疗组（1:1），使用计算机化的分组随机化过程。在两年内，我们招募了 81 名 CUD 患者中的 62 名。在研究的前 3 周内，患者接受了 15 次 15 Hz rTMS/假治疗，共 15 次，每次治疗都在左侧背外侧前额叶皮层（DLPFC）上进行，我们根据 5 厘米的方法定位 DLFPC。每周两次的可卡因尿液检测结果是主要结果。次要结果是渴求严重程度、可卡因使用模式和心理测量评估。
结果：我们将患者随机分配到 rTMS 组（32 例）或假治疗组（30 例）。rTMS 和假治疗组分别有 13 名（42%）和 12 名（43.3%）患者完成了完整的试验方案，显示出较高的脱落率。rTMS 治疗组 10/30（33%）的患者尿液可卡因检测呈阴性，而安慰剂对照组 4/27 例（p=0.18，比值比 2.88，CI 0.9-10）。卡普兰-迈耶生存曲线表明，在接受治疗和假治疗的患者中，可卡因尿液转阴的时间没有显著变化（p=0.20）。然而，rTMS 治疗组的可卡因相关线索引起的渴求严重程度（VAS 峰值）在治疗后（T1）显著降低（p<0.03），此时 rTMS 治疗结束。此外，rTMS 组和假治疗组的可卡因使用天数均显著减少（p<0.03）。最后，rTMS 治疗组的心理测量冲动性参数改善，而两组的抑郁量表均改善。
结论：在 CUD 中，rTMS 可能是降低可卡因渴求度和使用量的有效工具。
试验注册：clinicalTrials.gov 上的研究编号为 NCT03607591。
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