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Effect Study of Optimized Intervention to Heroin Addicts

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Shanghai Mental Health Center.
Recruitment status was:  Active, not recruiting
Information provided by:
Shanghai Mental Health Center Identifier:
First received: June 11, 2010
Last updated: March 10, 2011
Last verified: March 2011
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.

Condition Intervention
Heroin Dependence
Behavioral: cognitive behavioral therapy
Drug: methadone maintenance treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Barriers and Effect of Optimizing Intervention Protocols for Heroin Dependence in Community-based Methadone Maintenance Treatment (MMT): a Cohort Study

Resource links provided by NLM:

Further study details as provided by Shanghai Mental Health Center:

Primary Outcome Measures:
  • treatment retention [ Time Frame: 12 months ]
    retaining patients in the methadone maintenance treatment during and after the study.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 240
Study Start Date: April 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01144390

China, Shanghai
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
Shanghai, Shanghai, China, 200030
Sponsors and Collaborators
Shanghai Mental Health Center
Principal Investigator: min ZHAO, Ph.D. Shanghai Mental Health Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Min ZHAO, Shanghai Mental Health Center Identifier: NCT01144390     History of Changes
Other Study ID Numbers: ShanghaiMHC
Study First Received: June 11, 2010
Last Updated: March 10, 2011

Keywords provided by Shanghai Mental Health Center:
heroin dependence

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents processed this record on April 27, 2017