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

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ClinicalTrials.gov Identifier: NCT01580163
Recruitment Status : Completed
First Posted : April 18, 2012
Last Update Posted : November 18, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

April 17, 2012
April 18, 2012
November 18, 2015
September 2009
August 2013   (Final data collection date for primary outcome measure)
The drug use pattern during observation period [ Time Frame: 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
The change of drug use during treatment and observation period [ Time Frame: treatment period is 12 months and observation period is 12 months ]
We will compare the change of drug use with the control group after one year of treatment and stopping drug use one year.
Complete list of historical versions of study NCT01580163 on ClinicalTrials.gov Archive Site
  • The change of ASI(Addiction Severity Index) after the treatment and observation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
  • The change of ASI after the treatment and observation [ Time Frame: 52 weeks ]
    We will observe the change of ASI in the treatment after week 52 and week 52 after discontinuation
  • the change of NHI after treatment and observation [ Time Frame: 52 weeks ]
    We will observe the change of NHI in the treatment after week 52 and week 52 after discontinuation
  • the change of SF-36 after treatment and observation [ Time Frame: 52 weeks ]
    We will observe the change of SF-36 in the treatment after week 52 and week 52 after discontinuation
  • the change of SAS and SDS after treatment and observation [ Time Frame: 52 weeks ]
    We will observe the change of SAS and SDS in the treatment after week 52 and week 52 after discontinuation
Not Provided
Not Provided
 
Efficacy Evaluation of Traditional Chinese Medicine JITAI Combined Comprehensive Model Among Heroin Addicts After Detoxification
Efficacy Evaluation of Traditional Chinese Medicine JITAI Combined Comprehensive Model Among Heroin Addicts After Detoxification
The purpose of this research is to observe the efficacy of comprehensive treatment model to improve treatment compliance and relapse prevention.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Heroin Addiction
  • Drug: JITAI Combined with psychological intervention
    tablet,Each tablet weight 0.4g
  • Drug: Methadone
    Oral Solution,1mg/ml
  • Drug: Traditional Chinese Medicine JITAI
    tablet,Each tablet weight 0.4g
    Other Name: JITAI
  • Experimental: JITAI combined therapy group
    The investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community.
    Intervention: Drug: JITAI Combined with psychological intervention
  • Experimental: Methadone combined herapy group
    The investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community.
    Intervention: Drug: Methadone
  • Experimental: JITAI therapy group
    The investigator will adopt JITAI combined social support in Shanghai-related community and outside of Shanghai.
    Intervention: Drug: Traditional Chinese Medicine JITAI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
554
August 2013
August 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01580163
MZhao-002
No
Not Provided
Not Provided
Min ZHAO, Shanghai Mental Health Center
Shanghai Mental Health Center
Shanghai Center of Biomedicine Development
Principal Investigator: Min ZHAO, Ph.D. Shanghai Mental Health Center
Shanghai Mental Health Center
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP