Effect Study of Optimized Intervention to Heroin Addicts

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Shanghai Mental Health Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Shanghai Mental Health Center
ClinicalTrials.gov Identifier:
NCT01144390
First received: June 11, 2010
Last updated: March 10, 2011
Last verified: March 2011
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    retaining patients in the methadone maintenance treatment during and after the study.


Secondary Outcome Measures:
  • in-treatment performance. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144390

Locations
China, Shanghai
Mental Health Center of Pudong District
Shanghai, Shanghai, China, 200030
Mental Health Center of Hongkou District
Shanghai, Shanghai, China, 200030
Mental Health Center of Yangpu District
Shanghai, Shanghai, China, 200030
Mental Health Center of Xuhui District
Shanghai, Shanghai, China, 200030
Sponsors and Collaborators
Shanghai Mental Health Center
Investigators
Principal Investigator: min ZHAO, Ph.D. Shanghai Mental Health Center
  More Information

No publications provided

Responsible Party: Min ZHAO, Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT01144390     History of Changes
Other Study ID Numbers: ShanghaiMHC
Study First Received: June 11, 2010
Last Updated: March 10, 2011
Health Authority: China: Ethics Committee
United States: Institutional Review Board

Keywords provided by Shanghai Mental Health Center:
heroin dependence
community-based
MMT

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Heroin
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on April 23, 2014