- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01093248
Methadone Maintenance Treatment Outcome Study in Taiwan (M0508)
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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Miaoli, Taiwán
- Reclutamiento
- Departments of Psychiatry, Wei-Gong Memorial Hospital
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Investigador principal:
- Ming-Lun Liu, MD
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Contacto:
- Ming-Lun Liu, MD
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Taichung, Taiwán
- Reclutamiento
- Departments of Psychiatry, China Medical University and Hospital
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Investigador principal:
- Chieh-Liang Huang, MD
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Contacto:
- Chieh-Liang Huang, MD
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Taipei, Taiwán
- Reclutamiento
- Departments of Psychiatry, Taipei City Hospital Song-De Campus
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Investigador principal:
- Lien-Wen Su, MD
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Contacto:
- Lien-Wen Su, MD
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Taipei, Taiwán
- Reclutamiento
- Departments of Psychiatry, Taipei City Hospital Yang-Ming Campus
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Investigador principal:
- Yih-Hong Yang, MD
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Sub-Investigador:
- Yung-Chun Fang, MD
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Contacto:
- Yih-Hong Yang, MD
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Taipei, Taiwán
- Reclutamiento
- Departments of Psychiatry, Far-Eastern Memorial Hospital
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Investigador principal:
- Chi-Shin Wu, MD
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Sub-Investigador:
- Kai-Chi Fang, MD
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Contacto:
- Chi-Shin Wu, MD
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Taipei County, Taiwán
- Reclutamiento
- Departments of Psychiatry, En-Chu-Kong Hospital
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Investigador principal:
- Li-Nen Lin, MD
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Sub-Investigador:
- Yen-Feng Lin, MD
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Contacto:
- Li-Nen Lin, MD
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Tao-Yuan, Taiwán
- Reclutamiento
- Departments of Psychiatry, Tao-yuan Psychiatric Center
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Contacto:
- Happy Kuy-Lok Tan, MD, MPH
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Investigador principal:
- Happy Kuy-Lok Tan, MD, MPH
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Sub-Investigador:
- Sun-Yuan Chou, MD
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Sub-Investigador:
- Kuen-Hong Wu, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Heroin-addicted Patients
Heroin-addicted outpatient department (OPD) patients who seek help for methadone maintenance treatment
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 99A1-PHPP39 (Otro número de subvención/financiamiento: National Health Research Institutes)
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