Effect Study of Optimized Intervention to Heroin Addicts

Study Overview
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Brief Summary
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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
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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.

Official Title
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Barriers and Effect of Optimizing Intervention Protocols for Heroin Dependence in Community-based Methadone Maintenance Treatment (MMT): a Cohort Study

Conditions
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Heroin Dependence

Intervention / Treatment
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* Behavioral: cognitive behavioral therapy
* Drug: methadone maintenance treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT plus MMT<br>cognitive behavioral therapy for heroin addicts with methadone maintenance treatment | Behavioral: cognitive behavioral therapy<br>* cognitive behavioral therapy, one session per week and psycho-education lecture in group once per month<br>Drug: methadone maintenance treatment<br>* methadone maintenance treatment<br>|
| Active Comparator: methadone maintenance treatment<br>methadone maintenance treatment for heroin addicts | Drug: methadone maintenance treatment<br>* methadone maintenance treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment retention | retaining patients in the methadone maintenance treatment during and after the study. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-treatment performance. | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heroin dependence, community-based, MMT