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

NCT ID: NCT01580163

Last Updated: 2015-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

554 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-08-31

Brief Summary

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The purpose of this research is to observe the efficacy of comprehensive treatment model to improve treatment compliance and relapse prevention.

Detailed Description

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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.

Conditions

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Heroin Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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JITAI combined therapy group

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

Group Type EXPERIMENTAL

JITAI Combined with psychological intervention

Intervention Type DRUG

tablet，Each tablet weight 0.4g

Methadone combined herapy group

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

Group Type EXPERIMENTAL

Methadone

Intervention Type DRUG

Oral Solution，1mg/ml

JITAI therapy group

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

Group Type EXPERIMENTAL

Traditional Chinese Medicine JITAI

Intervention Type DRUG

tablet，Each tablet weight 0.4g

Interventions

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JITAI Combined with psychological intervention

tablet，Each tablet weight 0.4g

Intervention Type DRUG

Methadone

Oral Solution，1mg/ml

Intervention Type DRUG

Traditional Chinese Medicine JITAI

tablet，Each tablet weight 0.4g

Intervention Type DRUG

Other Intervention Names

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JITAI

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Center of Biomedicine Development

UNKNOWN

Sponsor Role collaborator

Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Min ZHAO

vise president

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Min ZHAO, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

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National Institute on Drug Dependence，Peking University

Beijing, Beijing Municipality, China

Site Status

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

Countries

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China

Other Identifiers

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MZhao-002

Identifier Type: -

Identifier Source: org_study_id