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Heroin AddictionM0508NCT01093248

Methadone Maintenance Treatment Outcome Study in Taiwan

An observational study of Heroin Addiction, run by National Health Research Institutes, Taiwan at 7 sites in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heroin Addiction
How many people
300 participants
Where
7 sitesTaiwan
Study dates
Jul 2009to Dec 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: heroin-addicted patients who seek help for methadone maintenance treatment

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Taiwan7 sites, 7 recruiting
  • Departments of Psychiatry, Wei-Gong Memorial Hospital

    Miaoli

    Ming-Lun Liu, MD

    Ming-Lun Liu, MD

    Recruiting
  • Departments of Psychiatry, China Medical University and Hospital

    Taichung

    Chieh-Liang Huang, MD

    Chieh-Liang Huang, MD

    Recruiting
  • Departments of Psychiatry, Far-Eastern Memorial Hospital

    Taipei

    Chi-Shin Wu, MD

    Chi-Shin Wu, MD

    Recruiting
  • Departments of Psychiatry, Taipei City Hospital Song-De Campus

    Taipei

    Lien-Wen Su, MD

    Lien-Wen Su, MD

    Recruiting
  • Departments of Psychiatry, Taipei City Hospital Yang-Ming Campus

    Taipei

    Yih-Hong Yang, MD

    Yih-Hong Yang, MD

    Recruiting
  • Departments of Psychiatry, En-Chu-Kong Hospital

    Taipei County

    Li-Nen Lin, MD

    Li-Nen Lin, MD

    Recruiting
  • Departments of Psychiatry, Tao-yuan Psychiatric Center

    Taoyuan

    Happy Kuy-Lok Tan, MD, MPH

    Happy Kuy-Lok Tan, MD, MPH

    Recruiting

Other trials in Taiwan

About this study

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.

Medical subject headings
Heroin Dependence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01093248
Study groupRoleWhat they receive
Heroin-addicted PatientsHeroin-addicted outpatient department (OPD) patients who seek help for methadone maintenance treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2010 (estimated)
  2. Study startJul 2009
  3. Primary completionDec 2012 (estimated)
  4. Study completionDec 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01093248
Sponsor's protocol ID
99A1-PHPP39
Other IDs
99A1-PHPP39
Acronym
M0508
Status last verified
Aug 2012
First submitted
24 Mar 2010
Last updated
15 Aug 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heroin Addiction, run by National Health Research Institutes, Taiwan at 7 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chun-Yu Chen, MS (886-37-246166 ext. 36747, cyc@nhri.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2012.

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