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

November 16, 2015 updated by: Min ZHAO, Shanghai Mental Health Center
The purpose of this research is to observe the efficacy of comprehensive treatment model to improve treatment compliance and relapse prevention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

554

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • National Institute on Drug Dependence，Peking University
    • Hunan
      • Changsha, Hunan, China
        • The Second Xiangya Hospital of Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JITAI combined therapy group
The investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community.
Drug: JITAI Combined with psychological intervention
tablet，Each tablet weight 0.4g
Experimental: Methadone combined herapy group
The investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community.
Drug: Methadone
Oral Solution，1mg/ml
Experimental: JITAI therapy group
The investigator will adopt JITAI combined social support in Shanghai-related community and outside of Shanghai.
Drug: Traditional Chinese Medicine JITAI
tablet，Each tablet weight 0.4g
Other Names:
  • JITAI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline ,26 weeks and 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline,26weeks and 52 weeks
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.
Baseline,26weeks and 52 weeks
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.
Baseline,26 weeks and 52 weeks
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.
Baseline ,26weeks and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Collaborators

Shanghai Center of Biomedicine Development

Investigators

  • Principal Investigator: min ZHAO, Ph.D., Shanghai Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

April 17, 2012

First Submitted That Met QC Criteria

April 17, 2012

First Posted (Estimate)

April 18, 2012

Study Record Updates

Last Update Posted (Estimate)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MZhao-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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