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Methadone Maintenance Treatment Outcome Study in Taiwan

NCT ID: NCT01093248

Last Updated: 2012-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-12-31

Brief Summary

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Opioid abuse is a complex problem, which not only impacts on the affected individuals' physical and psychological health, but also threatens public security and the productivity of the society. Further, through needle sharing and sexual contacts, injecting drug users (IDUs) have become laden with HIV and HIV related health problems, representing a serious public health threat all over the world. In Taiwan, since the identification of the first HIV-infected IDU in 1987, the incident cases have continued to increase, reaching a height of 2,461 in 2005. In order to contain the epidemics of HIV among IDUs, and to prevent its spread to the population in general, the Center for Disease Control (CDC) collaborated with the Department of Justice to initiate and implement a number of harm reduction programs in 2005. The fact that opioid addiction is officially treated as a health rather than a legal issue itself represents a remarkable milestone in Taiwan. Among these harm reduction programs, including needle and syringe exchange for IDUs as well as substitution treatment approaches for opioid dependence, methadone maintenance treatment (MMT) perhaps represents the most most important and most crucial component. Remarkably, in a relatively short time span, more than 60 MMT programs were established, which enrolled more than 15,000 heroin addicts. This notwithstanding, the overall and differential effectiveness of these MMT service delivery systems, as well as the characteristics of these programs and the patients that might contribute toward treatment response or failure remain largely unknown. Such knowledge base is crucial for establishing standardized and feasible outcome evaluation processes for opioid addicts receiving MMT programs, as well as for the further improvement of the efficacy and effectiveness of these programs, in Taiwan.

In order to address some of these issues, this study adopts a multi-site, prospective clinical follow-up design. It aims at establishing a research network for examining MMT outcome, developing standardized MMT outcome assessment instruments and procedures, and identifying predictors of MMT outcome. The findings may contribute to the better understanding of the characteristics of opioid addicts, the effectiveness of MMT and remaining service needs for opioid addicts in Taiwan.

Detailed Description

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Conditions

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Heroin Addiction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Heroin-addicted Patients

Heroin-addicted outpatient department (OPD) patients who seek help for methadone maintenance treatment

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Be 18 years or older.
* Be fulfilling the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria of opiate dependence.
* Be agree to and capable of signing informed consent form that has been approved by an Institution Review Board.

Exclusion Criteria

* Have ever participated in the study at one of the collaborative hospitals/clinics.
* Be expecting to discontinue methadone treatment for any reason (leaving the methadone clinic's geographic area, pending legal action, etc.) in the following 3 months.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Health Research Institutes, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sheng-Chang Wang, M.D.,M.Sc.

Role: PRINCIPAL_INVESTIGATOR

National Health Research Institutes, Taiwan

Locations

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Departments of Psychiatry, Wei-Gong Memorial Hospital

Miaoli, , Taiwan

Site Status RECRUITING

Departments of Psychiatry, China Medical University and Hospital

Taichung, , Taiwan

Site Status RECRUITING

Departments of Psychiatry, Far-Eastern Memorial Hospital

Taipei, , Taiwan

Site Status RECRUITING

Departments of Psychiatry, Taipei City Hospital Song-De Campus

Taipei, , Taiwan

Site Status RECRUITING

Departments of Psychiatry, Taipei City Hospital Yang-Ming Campus

Taipei, , Taiwan

Site Status RECRUITING

Departments of Psychiatry, En-Chu-Kong Hospital

Taipei County, , Taiwan

Site Status RECRUITING

Departments of Psychiatry, Tao-yuan Psychiatric Center

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chun-Yu Chen, MS

Role: CONTACT

Phone: 886-37-246166

Email: [email protected]

Facility Contacts

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Ming-Lun Liu, MD

Role: primary

Chieh-Liang Huang, MD

Role: primary

Chi-Shin Wu, MD

Role: primary

Lien-Wen Su, MD

Role: primary

Yih-Hong Yang, MD

Role: primary

Li-Nen Lin, MD

Role: primary

Happy Kuy-Lok Tan, MD, MPH

Role: primary

Other Identifiers

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99A1-PHPP39

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

99A1-PHPP39

Identifier Type: -

Identifier Source: org_study_id