NCT02282072Unknown1 期
PINS Stimulator System for Deep Brain Stimulation of the Nucleus Accumbens to Treat Severe Opioid Addiction
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Schedule for the Assessment of Negative Symptoms (SANS)
研究概览
简要总结
The purpose of this study is to verify efficacy and safety of a bilateral deep brain stimulation (DBS) of the Nucleus accumbens (NAc) as a treatment option for severe opioid addiction.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old.
- •In accordance with the diagnostic standards of DSM-IV & ICD-10 for addicted and DSM-IV for abstinence.
- •Qualitative urine detection for opioids showing positive result.
- •Cleared for 8 to 36 hours after their last drug taking.
- •Fully understood and signed on informed consent.
排除标准
- •Person with consciousness disorder on opioid abstinence, seriously aggressive, heavily dehydrated and intending to commit suicide.
- •Patients with serious liver and kidney dysfunction, pulmonary decompensation, or complicated with serious damage in other systems.
- •Patients with serious infectious disease.
- •Patients with history of serious neurological or psychiatrical diseases.
- •Person with history of HIV infection or serious malnutrition.
- •Dependent upon and addicted to multiple drugs.
- •Attended some other drug trials within one month.
研究组 & 干预措施
Deep Brain Stimulation
Active Comparator
Stimulator is ON
干预措施: Deep brain stimulation：PINS Stimulation System (Device)
Placebo
Sham Comparator
Stimulator is OFF
干预措施: Deep brain stimulation：PINS Stimulation System (Device)
结局指标
主要结局
Schedule for the Assessment of Negative Symptoms (SANS)
时间窗: 6 month
次要结局
- Chronic Hunger Scale(6 month)
- Beck Depression Inventory(6 month)
- Buss & Perry Aggression Questionnaire(6 month)
研究者
研究点 (1)
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