Methadone Maintenance Treatment Outcome Study in Taiwan
M0508
1 other identifier
observational
300
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2009
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 24, 2010
CompletedFirst Posted
Study publicly available on registry
March 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedAugust 15, 2012
August 1, 2012
3.4 years
March 24, 2010
August 14, 2012
Conditions
Study Arms (1)
Heroin-addicted Patients
Heroin-addicted outpatient department (OPD) patients who seek help for methadone maintenance treatment
Eligibility Criteria
heroin-addicted patients who seek help for methadone maintenance treatment
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Departments of Psychiatry, Wei-Gong Memorial Hospital
Miaoli, Taiwan
Departments of Psychiatry, China Medical University and Hospital
Taichung, Taiwan
Departments of Psychiatry, Far-Eastern Memorial Hospital
Taipei, Taiwan
Departments of Psychiatry, Taipei City Hospital Song-De Campus
Taipei, Taiwan
Departments of Psychiatry, Taipei City Hospital Yang-Ming Campus
Taipei, Taiwan
Departments of Psychiatry, En-Chu-Kong Hospital
Taipei County, Taiwan
Departments of Psychiatry, Tao-yuan Psychiatric Center
Taoyuan District, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sheng-Chang Wang, M.D.,M.Sc.
National Health Research Institutes, Taiwan
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2010
First Posted
March 25, 2010
Study Start
July 1, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
August 15, 2012
Record last verified: 2012-08