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Effect Study of Optimized Intervention to Heroin Addicts

Primary Purpose

Heroin Dependence

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cognitive behavioral therapy
methadone maintenance treatment
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heroin Dependence focused on measuring heroin dependence, community-based, MMT

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mental Health Center of Hongkou District
  • Mental Health Center of Pudong District
  • Mental Health Center of Xuhui District
  • Mental Health Center of Yangpu District

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT plus MMT

methadone maintenance treatment

Arm Description

cognitive behavioral therapy for heroin addicts with methadone maintenance treatment

methadone maintenance treatment for heroin addicts

Outcomes

Primary Outcome Measures

treatment retention
retaining patients in the methadone maintenance treatment during and after the study.

Secondary Outcome Measures

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.

Full Information

First Posted
June 11, 2010
Last Updated
March 10, 2011
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT01144390
Brief Title
Effect Study of Optimized Intervention to Heroin Addicts
Official Title
Barriers and Effect of Optimizing Intervention Protocols for Heroin Dependence in Community-based Methadone Maintenance Treatment (MMT): a Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Dependence
Keywords
heroin dependence, community-based, MMT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT plus MMT
Arm Type
Experimental
Arm Description
cognitive behavioral therapy for heroin addicts with methadone maintenance treatment
Arm Title
methadone maintenance treatment
Arm Type
Active Comparator
Arm Description
methadone maintenance treatment for heroin addicts
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavioral therapy
Intervention Description
cognitive behavioral therapy, one session per week and psycho-education lecture in group once per month
Intervention Type
Drug
Intervention Name(s)
methadone maintenance treatment
Intervention Description
methadone maintenance treatment
Primary Outcome Measure Information:
Title
treatment retention
Description
retaining patients in the methadone maintenance treatment during and after the study.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
in-treatment performance.
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
min ZHAO, Ph.D.
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mental Health Center of Hongkou District
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Mental Health Center of Pudong District
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Mental Health Center of Xuhui District
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Mental Health Center of Yangpu District
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26107818
Citation
Pan S, Jiang H, Du J, Chen H, Li Z, Ling W, Zhao M. Efficacy of Cognitive Behavioral Therapy on Opiate Use and Retention in Methadone Maintenance Treatment in China: A Randomised Trial. PLoS One. 2015 Jun 24;10(6):e0127598. doi: 10.1371/journal.pone.0127598. eCollection 2015.
Results Reference
derived

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Effect Study of Optimized Intervention to Heroin Addicts

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