Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.
Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, China.
BMJ Open. 2019 Feb 13;9(2):e023516. doi: 10.1136/bmjopen-2018-023516.
Deep brain stimulation (DBS) is a new potential surgical treatment for opioid dependence. However, the implement of DBS treatment in addicted patients is currently controversial due to the significant associated risks. The aim of this study was mainly to investigate the therapeutic efficacy and safety of bilateral DBS of nucleus accumbens and the anterior limb of the internal capsule (NAc/ALIC-DBS) in patients with refractory opioid dependence (ROD).
60 patients with ROD will be enrolled in this multicentre, prospective, double-blinded study, and will be followed up for 25 weeks (6 months) after surgery. Patients with ROD (semisynthetic opioids) who meet the criteria for NAc/ALIC-DBS surgery will be allocated to either the early stimulation group or the late stimulation group (control group) based on the randomised ID number. The primary outcome was defined as the abstinence rate at 25 weeks after DBS stimulation on, which will be confirmed by an opiate urine tests. The secondary outcomes include changes in the Visual Analogue Scale (VAS) score for craving for opioid drugs, body weight, as well as psychological evaluation measured using the 17-item Hamilton Depression Rating Scale, the Hamilton Anxiety Rating Scale, the Pittsburgh Sleep Quality Index, Fagerstrom test for nicotine dependence assessment, social disability screening schedule, the Activity of Daily Living Scale, the 36-item Short Form-Health Survey and safety profiles of both groups.
The study received ethical approval from the medical ethical committee of Tangdu Hospital, The Fourth Military Medical University, Xi'an, China. The results of this study will be published in a peer-reviewed journal and presented at international conferences.
NCT03424616; Pre-results.
脑深部电刺激（DBS）是一种治疗阿片类药物依赖的新的潜在手术治疗方法。然而，由于存在显著的相关风险，DBS 治疗在成瘾患者中的应用目前存在争议。本研究的主要目的是探讨双侧伏隔核和内囊前肢（NAc/ALIC-DBS）刺激治疗难治性阿片类药物依赖（ROD）患者的疗效和安全性。
将纳入 60 例 ROD 患者进行这项多中心、前瞻性、双盲研究，术后随访 25 周（6 个月）。符合 NAc/ALIC-DBS 手术标准的 ROD（半合成阿片类药物）患者将根据随机 ID 号分为早期刺激组或晚期刺激组（对照组）。主要结局定义为 DBS 刺激后 25 周的戒断率，将通过阿片类药物尿检来确认。次要结局包括阿片类药物渴求的视觉模拟量表（VAS）评分、体重、17 项汉密尔顿抑郁评定量表、汉密尔顿焦虑评定量表、匹兹堡睡眠质量指数、尼古丁依赖评估的 Fagerstrom 测试、社会残疾筛查量表、日常生活活动量表、36 项简明健康调查和两组的安全性概况的变化。
本研究得到了中国西安第四军医大学唐都医院医学伦理委员会的批准。这项研究的结果将发表在同行评议的期刊上，并在国际会议上展示。
NCT03424616；预结果。
