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

Shanghai Mental Health Center554 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

554

Conditions

Heroin Addiction

Interventions

JITAI Combined with psychological interventionDRUG

tablet，Each tablet weight 0.4g

MethadoneDRUG

Oral Solution，1mg/ml

Traditional Chinese Medicine JITAIDRUG

tablet，Each tablet weight 0.4g

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (2)

National Institute on Drug Dependence，Peking University

Beijing, Beijing Municipality, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Outcomes

Primary Outcomes

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

Time frame: Baseline ,26 weeks and 52 weeks

Secondary Outcomes

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.

Time frame: Baseline,26weeks and 52 weeks

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.

Time frame: Baseline,26weeks and 52 weeks

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.

Time frame: Baseline,26 weeks and 52 weeks

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.

Time frame: Baseline ,26weeks and 52 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.