Efficacy of Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy on Heroin Dependence
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Recurrence of heroin dependence
研究概览
简要总结
Heroin dependence is one of most common substance dependence, which brings great burden on health worldwide. Heroin dependence may lead to immunosuppression and cognitive impairments. Once heroin dependence is developed, it will be difficult to recover and easy to relapse. Although many efforts had been made in the treatment of heroin dependence, the annual recurrence of heroin dependence with traditional therapies would be up to 90%. Repetitive transcranial magnetic stimulation (rTMS) on the dorsolateral prefrontal cortex (DLPFC) or cognitive behavioral therapy (CBT) each alone was reported to have some effect on preventing from relapse of substance dependence. In order to test whether combined therapy of high frequency rTMS (hf-rTMS) with CBT is better for preventing from relapse of heroin dependence, we recruit patients with heroin dependence to participate this study. The study is a factorial designed and the patients will be assigned into one of the following six groups randomly: (1) regular treatment (symptomatic treatment) with blank TMS; (2) regular treatment (RT) with blank TMS and CBT; (3) RT with right DLPFC hf-rTMS; (4) RT with right DLPFC hf-rTMS and CBT; (5) RT with left DLPFC hf-rTMS; (6) RT with left DLPFC hf-rTMS and CBT. TMS was given 5 days per week for total 2 weeks using uniform scheme (5 seconds of 10Hz stimulation per train, 30 trains per day with inter-train interval of 20 seconds). CBT will be given once per week for total 8 weeks. The patients will be followed up for 6 months. Recurrence of heroin dependence, duration of abstention, heroin/drug intake, craving for heroin and other cognitive psychological assessments will be recorded and compared among the 6 treatment groups and the efficacy of combined therapy of rTMS with CBT will be evaluated in our study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis as heroin dependence according to DSM-IV criteria
- •No definite history of neurological diseases and psychological problems
- •Volunteer to participate the study, cooperate to be followed up
排除标准
- •Acute withdrawal state and CIWA score > 9
- •With other neurological diseases and psychological problems
- •With ever brain trauma and damage
- •With other psychological medications or other substance dependence
- •With other contraindications to have transcranial magnetic stimulation
研究组 & 干预措施
Regular treatment (symptomatic treatment) with blank TMS
Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation
干预措施: Transcranial magnetic stimulation and Cognitive behavioral therapy (Combination Product)
Regular treatment (RT) with blank TMS and CBT
Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation and cognitive behavioral therapy
干预措施: Transcranial magnetic stimulation and Cognitive behavioral therapy (Combination Product)
RT with right DLPFC hf-rTMS and CBT
Regular treatment with right DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT)
干预措施: Transcranial magnetic stimulation and Cognitive behavioral therapy (Combination Product)
RT with left DLPFC hf-rTMS
Regular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS)
干预措施: Transcranial magnetic stimulation and Cognitive behavioral therapy (Combination Product)
RT with left DLPFC hf-rTMS and CBT
Regular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT)
干预措施: Transcranial magnetic stimulation and Cognitive behavioral therapy (Combination Product)
RT with right DLPFC hf-rTMS
Regular treatment with right dorsolateral prefrontal cortex (DLPFC) high frequency repetitive transcranial magnetic stimulation (hf-rTMS)
干预措施: Transcranial magnetic stimulation and Cognitive behavioral therapy (Combination Product)
结局指标
主要结局
Recurrence of heroin dependence
时间窗: 6 month
The rate of relapse of heroin dependence after discharge from hospital
Recurrence of heroin dependence
时间窗: 3 month
The rate of relapse of heroin dependence after discharge from hospital
Recurrence of heroin dependence
时间窗: 1 month
The rate of relapse of heroin dependence after discharge from hospital
Recurrence of heroin dependence
时间窗: 2 month
The rate of relapse of heroin dependence after discharge from hospital
次要结局
- Duration of abstinence(6 months)
- Heroin consumption(2 weeks, 1 month, 2 months, 3 months and 6 months)
- Craving for heroin(2weeks, 1 month, 2 months, 3 months and 6 months)
- Cognitive assessment(2 weeks, 1 month, 2 months, 3 months and 6 months)
- Psychological assessment - Anxiety(2 weeks, 1 month, 2 months, 3 months and 6 months)
- Psychological assessment - Depression(2 weeks, 1 month, 2 months, 3 months and 6 months)
- Psychological assessment - Sleep(2 weeks, 1 month, 2 months, 3 months and 6 months)
- Craving for heroin(2 weeks, 1 month, 2 months, 3 months and 6 months)
研究者
Ying Peng
Professor, Director of Department of Neurology
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
