Effect Study of Optimized Intervention to Heroin Addicts

March 10, 2011 updated by: Shanghai Mental Health Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Mental Health Center of Hongkou District
      • Shanghai, Shanghai, China, 200030
        • Mental Health Center of Pudong District
      • Shanghai, Shanghai, China, 200030
        • Mental Health Center of Xuhui District
      • Shanghai, Shanghai, China, 200030
        • Mental Health Center of Yangpu District

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
treatment retention
Time Frame: 12 months
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.
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Investigators

  • Principal Investigator: min ZHAO, Ph.D., Shanghai Mental Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

June 11, 2010

First Submitted That Met QC Criteria

June 14, 2010

First Posted (Estimate)

June 15, 2010

Study Record Updates

Last Update Posted (Estimate)

March 11, 2011

Last Update Submitted That Met QC Criteria

March 10, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShanghaiMHC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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