Efficacy Evaluation of Traditional Chinese Medicine JITAI Combined Comprehensive Model Among Heroin Addicts After Detoxification
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| First Received Date ICMJE | April 17, 2012 | ||||||||
| Last Updated Date | April 27, 2012 | ||||||||
| Start Date ICMJE | September 2009 | ||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The drug use pattern during observation period [ Time Frame: Baseline ,26 weeks and 52 weeks ] [ Designated as safety issue: No ] 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 |
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| Original Primary Outcome Measures ICMJE |
The change of drug use during treatment and observation period [ Time Frame: treatment period is 12 months and observation period is 12 months ] [ Designated as safety issue: No ] We will compare the change of drug use with the control group after one year of treatment and stopping drug use one year. |
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| Change History | Complete list of historical versions of study NCT01580163 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Efficacy Evaluation of Traditional Chinese Medicine JITAI Combined Comprehensive Model Among Heroin Addicts After Detoxification | ||||||||
| Official Title ICMJE | Efficacy Evaluation of Traditional Chinese Medicine JITAI Combined Comprehensive Model Among Heroin Addicts After Detoxification | ||||||||
| Brief Summary | The purpose of this research is to observe the efficacy of comprehensive treatment model to improve treatment compliance and relapse prevention. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Heroin Addiction | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 930 | ||||||||
| Estimated Completion Date | June 2012 | ||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01580163 | ||||||||
| Other Study ID Numbers ICMJE | MZhao-002 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Min ZHAO, Shanghai Mental Health Center | ||||||||
| Study Sponsor ICMJE | Shanghai Mental Health Center | ||||||||
| Collaborators ICMJE | Shanghai Center of Biomedicine Development | ||||||||
| Investigators ICMJE |
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| Information Provided By | Shanghai Mental Health Center | ||||||||
| Verification Date | April 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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