Heroin Addiction
Conditions
Keywords
the opioid dependence in rehabilitation phase, community
Brief summary
The purpose of this research is to observe the efficacy of comprehensive treatment model to improve treatment compliance and relapse prevention.
Detailed description
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.
Interventions
tablet，Each tablet weight 0.4g
DRUGMethadone
Oral Solution，1mg/ml
DRUGTraditional Chinese Medicine JITAI
tablet，Each tablet weight 0.4g
Sponsors
Shanghai Center of Biomedicine Development
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The drug use pattern during observation period | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of ASI(Addiction Severity Index) after the treatment and observation | Baseline,26weeks and 52 weeks | The investigator will use ASI to describe the addiction severity of objects and compare the different change among different groups during observation period. |
| the change of drug use pattern during observation period | Baseline,26weeks 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. |
| the change of SF-36(the MOS item short form health survey) after treatment and observation | Baseline,26 weeks and 52 weeks | The investigator will use SF-36 to describe the health status of objects and compare the different change among different groups during observation period. |
| the change of SAS(Self-Rating Anxiety Scale) and SDS(Self-rating Depression Scale) during observation period | Baseline ,26weeks and 52 weeks | 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. |
Countries
China
Outcome results
None listed