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Methadone Maintenance Treatment Outcome Study in Taiwan (M0508)

14. august 2012 oppdatert av: National Health Research Institutes, Taiwan

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.

Studieoversikt

Status

Ukjent

Studietype

Observasjonsmessig

Registrering (Forventet)

300

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Miaoli, Taiwan
        • Rekruttering
        • Departments of Psychiatry, Wei-Gong Memorial Hospital
        • Hovedetterforsker:
          • Ming-Lun Liu, MD
        • Ta kontakt med:
          • Ming-Lun Liu, MD
      • Taichung, Taiwan
        • Rekruttering
        • Departments of Psychiatry, China Medical University and Hospital
        • Hovedetterforsker:
          • Chieh-Liang Huang, MD
        • Ta kontakt med:
          • Chieh-Liang Huang, MD
      • Taipei, Taiwan
        • Rekruttering
        • Departments of Psychiatry, Taipei City Hospital Song-De Campus
        • Hovedetterforsker:
          • Lien-Wen Su, MD
        • Ta kontakt med:
          • Lien-Wen Su, MD
      • Taipei, Taiwan
        • Rekruttering
        • Departments of Psychiatry, Taipei City Hospital Yang-Ming Campus
        • Hovedetterforsker:
          • Yih-Hong Yang, MD
        • Underetterforsker:
          • Yung-Chun Fang, MD
        • Ta kontakt med:
          • Yih-Hong Yang, MD
      • Taipei, Taiwan
        • Rekruttering
        • Departments of Psychiatry, Far-Eastern Memorial Hospital
        • Hovedetterforsker:
          • Chi-Shin Wu, MD
        • Underetterforsker:
          • Kai-Chi Fang, MD
        • Ta kontakt med:
          • Chi-Shin Wu, MD
      • Taipei County, Taiwan
        • Rekruttering
        • Departments of Psychiatry, En-Chu-Kong Hospital
        • Hovedetterforsker:
          • Li-Nen Lin, MD
        • Underetterforsker:
          • Yen-Feng Lin, MD
        • Ta kontakt med:
          • Li-Nen Lin, MD
      • Tao-Yuan, Taiwan
        • Rekruttering
        • Departments of Psychiatry, Tao-yuan Psychiatric Center
        • Ta kontakt med:
          • Happy Kuy-Lok Tan, MD, MPH
        • Hovedetterforsker:
          • Happy Kuy-Lok Tan, MD, MPH
        • Underetterforsker:
          • Sun-Yuan Chou, MD
        • Underetterforsker:
          • Kuen-Hong Wu, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

heroin-addicted patients who seek help for methadone maintenance treatment

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2009

Primær fullføring (Forventet)

1. desember 2012

Studiet fullført (Forventet)

1. desember 2012

Datoer for studieregistrering

Først innsendt

24. mars 2010

Først innsendt som oppfylte QC-kriteriene

24. mars 2010

Først lagt ut (Anslag)

25. mars 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

15. august 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. august 2012

Sist bekreftet

1. august 2012

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 99A1-PHPP39 (Annet stipend/finansieringsnummer: National Health Research Institutes)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Heroinavhengighet

3
Abonnere