NCT01093248

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

August 15, 2012

Status Verified

August 1, 2012

Enrollment Period

3.4 years

First QC Date

March 24, 2010

Last Update Submit

August 14, 2012

Conditions

Study Arms (1)

Heroin-addicted Patients

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

heroin-addicted patients who seek help for methadone maintenance treatment

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Departments of Psychiatry, Wei-Gong Memorial Hospital

Miaoli, Taiwan

RECRUITING

Departments of Psychiatry, China Medical University and Hospital

Taichung, Taiwan

RECRUITING

Departments of Psychiatry, Far-Eastern Memorial Hospital

Taipei, Taiwan

RECRUITING

Departments of Psychiatry, Taipei City Hospital Song-De Campus

Taipei, Taiwan

RECRUITING

Departments of Psychiatry, Taipei City Hospital Yang-Ming Campus

Taipei, Taiwan

RECRUITING

Departments of Psychiatry, En-Chu-Kong Hospital

Taipei County, Taiwan

RECRUITING

Departments of Psychiatry, Tao-yuan Psychiatric Center

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Conditions

Heroin Dependence

Condition Hierarchy (Ancestors)

Opioid-Related DisordersNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Sheng-Chang Wang, M.D.,M.Sc.

    National Health Research Institutes, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Yu Chen, MS

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2010

First Posted

March 25, 2010

Study Start

July 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

August 15, 2012

Record last verified: 2012-08

Locations