Effect Study of Optimized Intervention to Heroin Addicts
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Shanghai Mental Health Center.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Shanghai Mental Health Center
Information provided by:
Shanghai Mental Health Center
ClinicalTrials.gov Identifier:
NCT01144390
First received: June 11, 2010
Last updated: March 10, 2011
Last verified: March 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 11, 2010 | ||||
| Last Updated Date | March 10, 2011 | ||||
| Start Date ICMJE | April 2010 | ||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
treatment retention [ Time Frame: 12 months ] [ Designated as safety issue: No ] retaining patients in the methadone maintenance treatment during and after the study. |
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| Original Primary Outcome Measures ICMJE |
treatment retention [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01144390 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
in-treatment performance. [ Time Frame: 12 months ] [ Designated as safety issue: No ] treatment performance of addicts include: treatment sessions during the study, negative urine specimens, drop-out rate, severity of ASI,scores of HIV-related high risk sexual behavior, the temperature and character inventory, perceived stigma scale, self-esteem inventory,self efficacy, social support scores,drug use from self-report from baseline to 3 month and 6 month. |
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| Original Secondary Outcome Measures ICMJE |
in-treatment performance. [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect Study of Optimized Intervention to Heroin Addicts | ||||
| Official Title ICMJE | Barriers and Effect of Optimizing Intervention Protocols for Heroin Dependence in Community-based Methadone Maintenance Treatment (MMT): a Cohort Study | ||||
| Brief Summary | The purpose of this study is to explore barriers and determine whether optimizing protocol is effective in the treatment of heroin dependence in community-based MMT clinics. |
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| Detailed Description | Drug dependence is one of the most serious public health problems worldwide. In China, among more than 100, 0000 registered drug addicts mostly are heroin dependence. Drug dependence post great risks to physical condition, their family and society, and can lead to infectious disease transmission. Though almost 500 MMT clinics which can offer MMT service to heroin addicts have been set up, there are still some problems, for example, poor compliance, high rate of dropping out and relapse which affect the service delivery to them. The guideline developed by WHO focused on psychotherapy to opiate addicts with MMT. So delivery of a set of comprehensive, integrated psychotherapy to opiate addicts is very critical in such methadone clinics. |
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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: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Heroin Dependence | ||||
| 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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 240 | ||||
| Estimated Completion Date | June 2011 | ||||
| Estimated Primary Completion Date | June 2011 (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 | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01144390 | ||||
| Other Study ID Numbers ICMJE | ShanghaiMHC | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Min ZHAO, Shanghai Mental Health Center | ||||
| Study Sponsor ICMJE | Shanghai Mental Health Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Shanghai Mental Health Center | ||||
| Verification Date | March 2011 | ||||
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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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