Efficacy Evaluation of Traditional Chinese Medicine JITAI Combined Comprehensive Model Among Heroin Addicts After Detoxification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 554
- 试验地点
- 2
- 主要终点
- The drug use pattern during observation period
研究概览
简要总结
The purpose of this research is to observe the efficacy of comprehensive treatment model to improve treatment compliance and relapse prevention.
详细描述
The model include the Chinese traditional medicine JITAI combined with psychological intervention and social support for maintenance therapy after acute detoxification of heroin addicts.On the basis of the existing community management experience and community of professional anti-drug community service，The investigator will adopt the Chinese traditional medicine JITAI combined with psychological intervention and social support for maintenance therapy after acute detoxification of the community of heroin addicts.The purpose is to observe the comprehensive treatment model to improve treatment compliance and relapse prevention，then the investigator will form a new model of community humane drug treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Clinical Diagnosis of The opioid dependence
- •After detoxification.
- •Exclusion Criteria：
- •Clinical Diagnosis of glaucoma and other severe mental disorder；
- •serious organic disease within three months；
- •can not comply with the test requirements；
- •accept Hans therapy instrument；
- •have tendence of suicide，self-injury and impulse；
- •ECG abnormalities；
- •ALT or AST greater than 5 times the upper limit of normal；
- •history of epilepsy；
- •Lactating or pregnant women，or women of childbearing age fails to take effective contraceptive measures；
- •serious history of drug allergy or known allergy on traditional Chinese medicine JITAI；
- •Study before the withdrawal less than a half-life of 5.
排除标准
- 未提供
研究组 & 干预措施
JITAI combined therapy group
The investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community.
干预措施: JITAI Combined with psychological intervention (Drug)
Methadone combined herapy group
The investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community.
干预措施: Methadone (Drug)
JITAI therapy group
The investigator will adopt JITAI combined social support in Shanghai-related community and outside of Shanghai.
干预措施: Traditional Chinese Medicine JITAI (Drug)
结局指标
主要结局
The drug use pattern during observation period
时间窗: Baseline ,26 weeks and 52 weeks
The investigator will ues NHI(Nature History Interview) to describe the drug use pattern and and compare the different change among different groups during observation period
次要结局
- The change of ASI(Addiction Severity Index) after the treatment and observation(Baseline,26weeks and 52 weeks)
- the change of drug use pattern during observation period(Baseline,26weeks and 52 weeks)
- the change of SF-36(the MOS item short form health survey) after treatment and observation(Baseline,26 weeks and 52 weeks)
- the change of SAS(Self-Rating Anxiety Scale) and SDS(Self-rating Depression Scale) during observation period(Baseline ,26weeks and 52 weeks)
研究者
Min ZHAO
vise president
Shanghai Mental Health Center