Effect Study of Optimized Intervention to Heroin Addicts

Heroin Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01144390
• Other study ID #: ShanghaiMHC
• Status: Active, not recruiting
• Phase: N/A
• First received: June 11, 2010
• Last updated: March 10, 2011
• Start date: April 2010
• Est. completion date: June 2011

Study information

• Verified date: March 2011
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heroin Dependence

Intervention

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

Locations

Country	Name	City	State
China	Mental Health Center of Hongkou District	Shanghai	Shanghai
China	Mental Health Center of Pudong District	Shanghai	Shanghai
China	Mental Health Center of Xuhui District	Shanghai	Shanghai
China	Mental Health Center of Yangpu District	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment retention	retaining patients in the methadone maintenance treatment during and after the study.	12 months	No
Secondary	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.	12 months	No