- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
정황
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Miaoli, 대만
- 모병
- Departments of Psychiatry, Wei-Gong Memorial Hospital
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수석 연구원:
- Ming-Lun Liu, MD
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연락하다:
- Ming-Lun Liu, MD
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Taichung, 대만
- 모병
- Departments of Psychiatry, China Medical University and Hospital
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수석 연구원:
- Chieh-Liang Huang, MD
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연락하다:
- Chieh-Liang Huang, MD
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Taipei, 대만
- 모병
- Departments of Psychiatry, Taipei City Hospital Song-De Campus
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수석 연구원:
- Lien-Wen Su, MD
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연락하다:
- Lien-Wen Su, MD
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Taipei, 대만
- 모병
- Departments of Psychiatry, Taipei City Hospital Yang-Ming Campus
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수석 연구원:
- Yih-Hong Yang, MD
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부수사관:
- Yung-Chun Fang, MD
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연락하다:
- Yih-Hong Yang, MD
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Taipei, 대만
- 모병
- Departments of Psychiatry, Far-Eastern Memorial Hospital
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수석 연구원:
- Chi-Shin Wu, MD
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부수사관:
- Kai-Chi Fang, MD
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연락하다:
- Chi-Shin Wu, MD
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Taipei County, 대만
- 모병
- Departments of Psychiatry, En-Chu-Kong Hospital
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수석 연구원:
- Li-Nen Lin, MD
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부수사관:
- Yen-Feng Lin, MD
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연락하다:
- Li-Nen Lin, MD
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Tao-Yuan, 대만
- 모병
- Departments of Psychiatry, Tao-yuan Psychiatric Center
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연락하다:
- Happy Kuy-Lok Tan, MD, MPH
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수석 연구원:
- Happy Kuy-Lok Tan, MD, MPH
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부수사관:
- Sun-Yuan Chou, MD
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부수사관:
- Kuen-Hong Wu, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Heroin-addicted Patients
Heroin-addicted outpatient department (OPD) patients who seek help for methadone maintenance treatment
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 99A1-PHPP39 (기타 보조금/기금 번호: National Health Research Institutes)
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