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Clinical Trials/NCT01580163
NCT01580163
Completed
Not Applicable

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

Shanghai Mental Health Center2 sites in 1 country554 target enrollmentSeptember 2009

Overview

Phase
Not Applicable
Intervention
JITAI Combined with psychological intervention
Conditions
Heroin Addiction
Sponsor
Shanghai Mental Health Center
Enrollment
554
Locations
2
Primary Endpoint
The drug use pattern during observation period
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
August 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Min ZHAO

vise president

Shanghai Mental Health Center

Eligibility Criteria

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;

Exclusion Criteria

  • Not provided

Arms & Interventions

JITAI combined therapy group

The investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community.

Intervention: JITAI Combined with psychological intervention

Methadone combined herapy group

The investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community.

Intervention: Methadone

JITAI therapy group

The investigator will adopt JITAI combined social support in Shanghai-related community and outside of Shanghai.

Intervention: Traditional Chinese Medicine JITAI

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • The change of ASI(Addiction Severity Index) after the treatment and observation(Baseline,26weeks and 52 weeks)
  • the change of drug use pattern during observation period(Baseline,26weeks and 52 weeks)
  • the change of SF-36(the MOS item short form health survey) after treatment and observation(Baseline,26 weeks and 52 weeks)
  • the change of SAS(Self-Rating Anxiety Scale) and SDS(Self-rating Depression Scale) during observation period(Baseline ,26weeks and 52 weeks)

Study Sites (2)

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