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

Primary Purpose

Heroin Addiction

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
JITAI Combined with psychological intervention
Methadone
Traditional Chinese Medicine JITAI
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heroin Addiction focused on measuring the opioid dependence in rehabilitation phase, community

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

JITAI combined therapy group

Methadone combined herapy group

JITAI therapy group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

The drug use pattern during observation period
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 Outcome Measures

The change of ASI(Addiction Severity Index) after the treatment and observation
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
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
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
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.

Full Information

First Posted
April 17, 2012
Last Updated
November 16, 2015
Sponsor
Shanghai Mental Health Center
Collaborators
Shanghai Center of Biomedicine Development
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1. Study Identification

Unique Protocol Identification Number
NCT01580163
Brief Title
Efficacy Evaluation of Traditional Chinese Medicine JITAI Combined Comprehensive Model Among Heroin Addicts After Detoxification
Official Title
Efficacy Evaluation of Traditional Chinese Medicine JITAI Combined Comprehensive Model Among Heroin Addicts After Detoxification
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Mental Health Center
Collaborators
Shanghai Center of Biomedicine Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Addiction
Keywords
the opioid dependence in rehabilitation phase, community

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
554 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JITAI combined therapy group
Arm Type
Experimental
Arm Description
The investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community.
Arm Title
Methadone combined herapy group
Arm Type
Experimental
Arm Description
The investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community.
Arm Title
JITAI therapy group
Arm Type
Experimental
Arm Description
The investigator will adopt JITAI combined social support in Shanghai-related community and outside of Shanghai.
Intervention Type
Drug
Intervention Name(s)
JITAI Combined with psychological intervention
Intervention Description
tablet，Each tablet weight 0.4g
Intervention Type
Drug
Intervention Name(s)
Methadone
Intervention Description
Oral Solution，1mg/ml
Intervention Type
Drug
Intervention Name(s)
Traditional Chinese Medicine JITAI
Other Intervention Name(s)
JITAI
Intervention Description
tablet，Each tablet weight 0.4g
Primary Outcome Measure Information:
Title
The drug use pattern during observation period
Description
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
Time Frame
Baseline ,26 weeks and 52 weeks
Secondary Outcome Measure Information:
Title
The change of ASI(Addiction Severity Index) after the treatment and observation
Description
The investigator will use ASI to describe the addiction severity of objects and compare the different change among different groups during observation period.
Time Frame
Baseline,26weeks and 52 weeks
Title
the change of drug use pattern during observation period
Description
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.
Time Frame
Baseline,26weeks and 52 weeks
Title
the change of SF-36(the MOS item short form health survey) after treatment and observation
Description
The investigator will use SF-36 to describe the health status of objects and compare the different change among different groups during observation period.
Time Frame
Baseline,26 weeks and 52 weeks
Title
the change of SAS(Self-Rating Anxiety Scale) and SDS(Self-rating Depression Scale) during observation period
Description
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.
Time Frame
Baseline ,26weeks and 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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； 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min ZHAO, Ph.D.
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute on Drug Dependence，Peking University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China

12. IPD Sharing Statement

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

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