Methadone Maintenance Treatment Outcome Study in Taiwan

Heroin Addiction Clinical Trial

— M0508  

Official title:

Methadone Maintenance Treatment Outcome Study in Taiwan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01093248
• Other study ID #: 99A1-PHPP39
• Secondary ID: 99A1-PHPP39
• Status: Recruiting
• Phase: N/A
• First received: March 24, 2010
• Last updated: August 14, 2012
• Start date: July 2009
• Est. completion date: December 2012

Study information

• Verified date: August 2012
• Source: National Health Research Institutes, Taiwan
• Contact: Chun-Yu Chen, MS
• Phone: 886-37-246166
• Email: cyc[@]nhri.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: National Health Research Institutes
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heroin Addiction
• Heroin Dependence

Locations

Country	Name	City	State
Taiwan	Departments of Psychiatry, Wei-Gong Memorial Hospital	Miaoli
Taiwan	Departments of Psychiatry, China Medical University and Hospital	Taichung
Taiwan	Departments of Psychiatry, Far-Eastern Memorial Hospital	Taipei
Taiwan	Departments of Psychiatry, Taipei City Hospital Song-De Campus	Taipei
Taiwan	Departments of Psychiatry, Taipei City Hospital Yang-Ming Campus	Taipei
Taiwan	Departments of Psychiatry, En-Chu-Kong Hospital	Taipei County
Taiwan	Departments of Psychiatry, Tao-yuan Psychiatric Center	Tao-Yuan

Sponsors (1)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan

Country where clinical trial is conducted

Taiwan,