CClinicalTrials.gg
Status unknownNCT01093248M0508Updated Aug 15, 2012

Methadone Maintenance Treatment Outcome Study in Taiwan

An observational study in Heroin Addiction, sponsored by National Health Research Institutes, Taiwan. Status unknown at 7 sites in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-15.

Sponsored by National Health Research Institutes, Taiwan · Observational

The sponsor has not verified this record recently (last verified Aug 2012), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heroin Addiction

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03

In context

Heroin Dependence

87 studies on the registry are indexed under Heroin Dependence; none are open to participants now.

This study's planned enrollment of 300 is above the median of 26 across 16 observational studies indexed under Heroin Dependence.

Browse Heroin Dependence studies →

Lead sponsor

National Health Research Institutes, Taiwan is the lead sponsor of 125 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

heroin-addicted patients who seek help for methadone maintenance treatment

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
300 participants (estimated)

Groups and cohorts

  • Heroin-addicted Patients

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

06

Study locations

7 of 7 sites recruiting
  • Departments of Psychiatry, Wei-Gong Memorial Hospital
    Miaoli, Taiwan
    • Ming-Lun Liu, MD · Contact
    • Ming-Lun Liu, MD · Principal investigator
    Recruiting
  • Departments of Psychiatry, China Medical University and Hospital
    Taichung, Taiwan
    • Chieh-Liang Huang, MD · Contact
    • Chieh-Liang Huang, MD · Principal investigator
    Recruiting
  • Departments of Psychiatry, En-Chu-Kong Hospital
    Taipei County, Taiwan
    • Li-Nen Lin, MD · Contact
    • Li-Nen Lin, MD · Principal investigator
    • Yen-Feng Lin, MD · Sub investigator
    Recruiting
  • Departments of Psychiatry, Far-Eastern Memorial Hospital
    Taipei, Taiwan
    • Chi-Shin Wu, MD · Contact
    • Chi-Shin Wu, MD · Principal investigator
    • Kai-Chi Fang, MD · Sub investigator
    Recruiting
  • Departments of Psychiatry, Taipei City Hospital Song-De Campus
    Taipei, Taiwan
    • Lien-Wen Su, MD · Contact
    • Lien-Wen Su, MD · Principal investigator
    Recruiting
  • Departments of Psychiatry, Taipei City Hospital Yang-Ming Campus
    Taipei, Taiwan
    • Yih-Hong Yang, MD · Contact
    • Yih-Hong Yang, MD · Principal investigator
    • Yung-Chun Fang, MD · Sub investigator
    Recruiting
  • Departments of Psychiatry, Tao-yuan Psychiatric Center
    Tao-Yuan, Taiwan
    • Happy Kuy-Lok Tan, MD, MPH · Contact
    • Happy Kuy-Lok Tan, MD, MPH · Principal investigator
    • Sun-Yuan Chou, MD · Sub investigator
    • Kuen-Hong Wu, MD · Sub investigator
    Recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01093248
Lead sponsor
National Health Research Institutes, Taiwan
Responsible party
Sponsor
First posted
Mar 25, 2010
Start date
Jul 2009
Primary completion
Dec 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Aug 15, 2012

Study contacts

Chun-Yu Chen, MS
Contact
cyc@nhri.org.tw
886-37-246166 ext. 36747
Sheng-Chang Wang, M.D.,M.Sc.
principal investigator · National Health Research Institutes, Taiwan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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