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.

Study Overview

• Status: Unknown
• Conditions: Heroin Addiction

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

heroin-addicted patients who seek help for methadone maintenance treatment

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Heroin-addicted Patients; Heroin-addicted outpatient department (OPD) patients who seek help for methadone maintenance treatment

Collaborators and Investigators

• Sponsor: National Health Research Institutes, Taiwan

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: March 24, 2010
• First Submitted That Met QC Criteria: March 24, 2010
• First Posted (Estimate): March 25, 2010

Study Record Updates

• Last Update Posted (Estimate): August 15, 2012
• Last Update Submitted That Met QC Criteria: August 14, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Heroin Dependence
• Other Study ID Numbers: 99A1-PHPP39 (Other Grant/Funding Number: National Health Research Institutes)