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临床试验/NCT03922659
NCT03922659Unknown不适用

Efficacy of Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy on Heroin Dependence

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年6月30日最近更新:
适应症
干预措施

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

Placebo Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ying Peng

Professor, Director of Department of Neurology

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

研究点 (1)

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