Efficacy Evaluation of Traditional Chinese Medicine JITAI Combined Comprehensive Model Among Heroin Addicts After Detoxification

Study Overview
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Brief Summary
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The purpose of this research is to observe the efficacy of comprehensive treatment model to improve treatment compliance and relapse prevention.

Detailed Description
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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.

Official Title
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Efficacy Evaluation of Traditional Chinese Medicine JITAI Combined Comprehensive Model Among Heroin Addicts After Detoxification

Conditions
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Heroin Addiction

Intervention / Treatment
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* Drug: JITAI Combined with psychological intervention
* Drug: Methadone
* Drug: Traditional Chinese Medicine JITAI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JITAI combined therapy group<br>The investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community. | Drug: JITAI Combined with psychological intervention<br>* tablet，Each tablet weight 0.4g<br>|
| Experimental: Methadone combined herapy group<br>The investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community. | Drug: Methadone<br>* Oral Solution，1mg/ml<br>|
| Experimental: JITAI therapy group<br>The investigator will adopt JITAI combined social support in Shanghai-related community and outside of Shanghai. | Drug: Traditional Chinese Medicine JITAI<br>* tablet，Each tablet weight 0.4g<br>* Other names: JITAI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The drug use pattern during observation period | 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 | Baseline ,26 weeks and 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of ASI(Addiction Severity Index) after the treatment and observation | The investigator will use ASI to describe the addiction severity of objects and compare the different change among different groups during observation period. | Baseline,26weeks and 52 weeks | 
| the change of drug use pattern during observation period | 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. | Baseline,26weeks and 52 weeks | 
| the change of SF-36(the MOS item short form health survey) after treatment and observation | The investigator will use SF-36 to describe the health status of objects and compare the different change among different groups during observation period. | Baseline,26 weeks and 52 weeks | 
| the change of SAS(Self-Rating Anxiety Scale) and SDS(Self-rating Depression Scale) during observation period | The investigator will use SAS and SDS to describe the anxiety status and depression status then compare the different change among different groups during observation period. | Baseline ,26weeks and 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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the opioid dependence in rehabilitation phase, community