Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse Prevention:A Multicenter Randomized Double-Blind Sham-stimulation Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- The abstinent rate at 25 weeks after DBS stimulation on （Urine Tests）
研究概览
简要总结
Nucleus accumbens plays important roles in the process of opiate addiction and initial of relapse after detoxification.According to the single-centered preliminary open-labeled prospective trial results, the investigators hypothesize that bilateral stimulation of the NAc will effectively reduce the relapse of the opiate dependence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old < Age < 50 years old
- •Moderate to severe opiates abuse disorders (fulfilled diagnostic-criteria according to DSM-5)
- •History of opiates abuse no less than 3 years
- •Failure of at least three addiction treatments ( in hospital or compulsive rehabilitation）, among which failure of methadone maintenance treatment must be met
- •completion of detoxification ( Negative urine test for morphine, methamphetamine, ketamine and buprenorphine)
- •Free patient's decision/informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance, known the benefit and risk of the treatment)
排除标准
- •Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases, severe personality disorder)
- •Contraindications of a MRI-examination, e.g. implanted cardiac pacemaker/heart defibrillator
- •Abuse of other type of drugs
- •severe cognitive impairments
- •Enrollment in other clinical trials
- •Stereotactic respectively neurosurgical intervention in the past
- •Contraindications of a stereotactic operation, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases)
- •Serious and instable organic diseases (e.g. instable coronal heart disease)
- •tested positively for HIV
- •pregnancy and/or lactation
- •Severe disorders for coagulation and liver function
- •Epilepsy or other severe brain trauma or neurological impairments
研究组 & 干预措施
Postoperative immediate Deep brain stimulation
The addicts undergone the deep brain stimulation while the stimulation (Suzhou Sceneray® DBS System) was turned on 1-2 weeks postoperatively.
干预措施: Suzhou Sceneray® DBS System (Device)
Postoperative delayed Deep brain stimulation
The addicts undergone the deep brain stimulation while the stimulation (Suzhou Sceneray® DBS System) was off until 25 months postoperatively, during which the following up was kept, then the the stimulation was turned on 25 months postoperatively.
干预措施: Suzhou Sceneray® DBS System (Device)
结局指标
主要结局
The abstinent rate at 25 weeks after DBS stimulation on （Urine Tests）
时间窗: At 25 weeks after DBS stimulation on
If the participants or their families report no less than 2 times of the drug use in each of two consecutive weeks, or the consecutive 2 times of urine tests showed positive, or lost of follow-up, the case was defined as relapse
次要结局
- The total days of abstinence for participants(Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- The longest duration for sustained abstinence for participants(Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- The rate of positive urine test results(Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- Pittsburgh sleep quality index(PSQI)(Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- 36-Item Short Form Health Survey (SF-36)(Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- Hamilton Depression Scale（HAMD-17)(Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- Scaling for Opiate withdrawal symptoms(Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- Visual analog scale (VAS) craving score for opioid drugs(Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- The evaluation on MATRICS-test(Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- Hamilton Anxiety Scale (HAMA)(Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- Fagerstrom Test Nicotine Dependence assessment (FTND)(Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- Body weight for participants(Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- Social Disability Screening Schedule (SDSS)(Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- Activity of Daily Living Scale (ADL)(Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on)