Effect Study of Optimized Intervention to Heroin Addicts

Not Applicable

• Conditions: Heroin Dependence
• Interventions: Drug: methadone maintenance treatment; Behavioral: cognitive behavioral therapy

• Registration Number: NCT01144390
• Lead Sponsor: Shanghai Mental Health Center

Brief Summary

The purpose of this study is to explore barriers and determine whether optimizing protocol is effective in the treatment of heroin dependence in community-based MMT clinics.

Detailed Description

Drug dependence is one of the most serious public health problems worldwide. In China, among more than 100, 0000 registered drug addicts mostly are heroin dependence. Drug dependence post great risks to physical condition, their family and society, and can lead to infectious disease transmission. Though almost 500 MMT clinics which can offer MMT service to heroin addicts have been set up, there are still some problems, for example, poor compliance, high rate of dropping out and relapse which affect the service delivery to them. The guideline developed by WHO focused on psychotherapy to opiate addicts with MMT. So delivery of a set of comprehensive, integrated psychotherapy to opiate addicts is very critical in such methadone clinics.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-06-11
• Study First Submitted QC: 2010-06-14
• Study First Posted: 2010-06-15
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-10
• Last Update Posted: 2011-03-11
• Primary Completion: 2011-06
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• clinical diagnosis of heroin dependence
• must be able to take methadone

Exclusion Criteria

• schizophrenia and mood disorder
• physical disabilities who could not come to take part in psychotherapy sessions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
methadone maintenance treatment	methadone maintenance treatment	methadone maintenance treatment for heroin addicts
CBT plus MMT	cognitive behavioral therapy	cognitive behavioral therapy for heroin addicts with methadone maintenance treatment
CBT plus MMT	methadone maintenance treatment	cognitive behavioral therapy for heroin addicts with methadone maintenance treatment

Primary Outcome Measures

Name	Time	Method
treatment retention	12 months	retaining patients in the methadone maintenance treatment during and after the study.

Secondary Outcome Measures

Name	Time	Method
in-treatment performance.	12 months	treatment performance of addicts include: treatment sessions during the study, negative urine specimens, drop-out rate, severity of ASI,scores of HIV-related high risk sexual behavior, the temperature and character inventory, perceived stigma scale, self-esteem inventory,self efficacy, social support scores,drug use from self-report from baseline to 3 month and 6 month.

Trial Locations

Locations (4)

Mental Health Center of Hongkou District; 🇨🇳 Shanghai, Shanghai, China

Mental Health Center of Pudong District; 🇨🇳 Shanghai, Shanghai, China

Mental Health Center of Xuhui District; 🇨🇳 Shanghai, Shanghai, China

Mental Health Center of Yangpu District; 🇨🇳 Shanghai, Shanghai, China