Clinical trial NCT01093248: Methadone Maintenance Treatment Outcome Study in Taiwan
Official title: Methadone Maintenance Treatment Outcome Study in Taiwan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heroin Addiction
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
First posted: 2010-03-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: heroin-addicted patients who seek help for methadone maintenance treatment

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miaoli
country: Taiwan
facility: Departments of Psychiatry, Wei-Gong Memorial Hospital
city: Taichung
country: Taiwan
facility: Departments of Psychiatry, China Medical University and Hospital
city: Taipei County
country: Taiwan
facility: Departments of Psychiatry, En-Chu-Kong Hospital
city: Taipei
country: Taiwan
facility: Departments of Psychiatry, Far-Eastern Memorial Hospital
city: Taipei
country: Taiwan
facility: Departments of Psychiatry, Taipei City Hospital Song-De Campus
city: Taipei
country: Taiwan
facility: Departments of Psychiatry, Taipei City Hospital Yang-Ming Campus
city: Tao-Yuan
country: Taiwan
facility: Departments of Psychiatry, Tao-yuan Psychiatric Center
Study officials:
affiliation: National Health Research Institutes, Taiwan
name: Sheng-Chang Wang, M.D.,M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: