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

Not Applicable

Completed

• Conditions: Heroin Addiction
• Interventions: Drug: Traditional Chinese Medicine JITAI; Drug: JITAI Combined with psychological intervention; Drug: Methadone

• Registration Number: NCT01580163
• Lead Sponsor: Shanghai Mental Health Center

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2012-04-17
• Study First Submitted QC: 2012-04-17
• Study First Posted: 2012-04-18
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 554

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JITAI therapy group	Traditional Chinese Medicine JITAI	The investigator will adopt JITAI combined social support in Shanghai-related community and outside of Shanghai.
JITAI combined therapy group	JITAI Combined with psychological intervention	The investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community.
Methadone combined herapy group	Methadone	The investigator will adopt JITAI combined psychological intervention and social support in Shanghai-related community.

Primary Outcome Measures

Name	Time	Method
The drug use pattern during observation period	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 Outcome Measures

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

Trial Locations

Locations (2)

National Institute on Drug Dependence，Peking University; 🇨🇳 Beijing, Beijing, China

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China