The Diagnostic Assessment and Intervention Study of Amphetamine Type Stimulus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- the prevalence of ATS abuse or dependence characteristics and pathogenesis
研究概览
简要总结
The purpose of this research is to inspire new medical ideas using brain image technology for the treatment of Amphetamine Type Stimulus addition, at the same time lowing the addition damage.
详细描述
The study will increase the sample size based on the preliminary work,also, establish drug dependence induced craving associated environmental experiments , by using the multi-lead biofeedback instrument , CogState tester, event-related potentials Recorder and 3.0T high-field magnetic resonance imaging system to record the physiology , electrophysiology and brain changes during craving, taking a subjective self-assessment , clinical observations and physiological responses combined system to evaluate the ATS addiction degree.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No previous history of any mental disorder meet the DSM-IV diagnosis
- •aged 18-49 years old , men and women
- •junior high school or higher education
- •use of amphetamine-type substances time for more than one year
- •cumulative use of amphetamines, substances dose of 50 grams or more.
排除标准
- •Current or past had suffered neurological diseases
- •exclusion of antisocial personality disorder and borderline personality disorder
- •addicts in addition to other substances in tobacco , coffee, social drinking outside
- •AIDS virus (HIV) detection positive patients .
研究组 & 干预措施
general information
use cross-sectional study to collect 1000 ATS abuse or dependence patients' general information and 5 ml blood,get their blood plasma and DNA sample in order to explore the possible addict mechanism.
ATS diagnosis and evaluation for abusers
Use cohort study design to establish ATS abuse induced craving experiment.Do the initial and follow-up assessment from start smoking to stop smoking after 4 weeks, 12 weeks, 26 weeks, 52 weeks and 26 weeks of returning to the community . Thus compare with normal group to explore the possible psychological abuse mechanism.
psychological training intervention
The main content is self-awareness training, social and moral strengthening, impulse control training , problem solving training , situational awareness training , HIV prevention, social skills training under the family atmosphere , family social skills training , interpersonal skills training, community interaction skills training , psychiatric symptoms of self-monitoring skills training and so on.
干预措施: psychological rehabilitation training (Behavioral)
brain stimulation intervention
Use randomized, prospective pseudo stimulus controlled clinical trial design, evaluation of repetitive transcranial magnetic stimulation of the left frontal lobe dorsal lateral effect on ATS dependent induced cognitive dysfunction and other symptoms.
干预措施: rTMS 10HZ high frequency stimulation (Radiation)
ATS diagnosis and evaluation for normal people
Do the same initial and follow-up assessment as ATS abusers who stop smoking after 4 weeks, 12 weeks, 26 weeks, 52 weeks and 26 weeks of returning to the community .
physical and neurological rehabilitation
The main content is drug rehabilitation exercise and functional physical training. Rehabilitation led by the discipline cadres , practice once a day, each lasting about 15 minutes .
干预措施: physical and neurological rehabilitation training (Behavioral)
fake brain stimulation intervention
fake transcranial magnetic stimulation of the left frontal lobe dorsal lateral effect on ATS dependent induced cognitive dysfunction and other symptoms.
干预措施: fake rTMS 10HZ high frequency stimulation (Radiation)
结局指标
主要结局
the prevalence of ATS abuse or dependence characteristics and pathogenesis
时间窗: Baseline
Plasma and DNA samples were collected to carry out the biochemical genetics and immunology research of ATS abuse or dependence , and to explore the prevalence of ATS abuse or dependence characteristics and pathogenesis.
the physiological psychology and cognitive impairment characteristic of ATS addicts,trends and ATS conducted cases.
时间窗: Baseline
Use repeatable battery for the assessment of neuropsychological status(RBANS),Cog-state cognitive function assessment test,event-related potentials(ERPs),functional magnetic resonance imaging(fMRI) in biology ( molecular genetics, blood biochemistry, electrophysiology , imaging ) , psychology, mental health and other aspects of the system to assess the physiological psychology and cognitive impairment characteristic of ATS addicts , trends and ATS conducted cases.
次要结局
未报告次要终点
研究者
Min ZHAO
Vice President
Shanghai Mental Health Center