Effect Study of Optimized Intervention to Heroin Addicts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01144390
Recruitment Status : Unknown
Verified March 2011 by Shanghai Mental Health Center.
Recruitment status was:  Active, not recruiting
First Posted : June 15, 2010
Last Update Posted : March 11, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Heroin Dependence Behavioral: cognitive behavioral therapy Drug: methadone maintenance treatment Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : April 2010
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heroin
U.S. FDA Resources

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

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

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: June 15, 2010    Key Record Dates
Last Update Posted: March 11, 2011
Last Verified: March 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