Efficacy of Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy on Alcohol Dependence
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The rate of relapse of alcohol dependence after discharge from hospital
研究概览
简要总结
Alcohol dependence is one of most common substance dependence, which brings great burden on health worldwide. Alcohol dependence may lead to many serious diseases or consequences including cancer, cardiovascular diseases and accidents. Once alcohol dependence is developed, it will be difficult to recover and easy to relapse. Although many efforts had been made in the treatment of alcohol dependence, the annual recurrence of alcohol dependence with traditional therapies was over 45%. 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 alcohol dependence. In order to test whether combined therapy of high frequency rTMS (hf-rTMS) with CBT is better for preventing from relapse of alcohol dependence, we recruit patients with alcohol 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 alcohol dependence, duration of abstention, alcohol intake, craving for alcohol 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 alcohol 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
结局指标
主要结局
The rate of relapse of alcohol dependence after discharge from hospital
时间窗: 6 month
次要结局
- Alcohol intake(2 weeks, 1 month, 2 months, 3 months and 6 months)
- Cognitive assessment(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)
- Duration of abstinence(6 months)
- Psychological assessment - Anxiety(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 alcohol(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
