Methadone Maintenance Outcome Study in Taiwan: 5-year Follow-up

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02524912
Recruitment Status : Unknown
Verified September 2015 by National Health Research Institutes, Taiwan.
Recruitment status was:  Active, not recruiting
First Posted : August 17, 2015
Last Update Posted : November 20, 2015
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan

Brief Summary:

Methadone maintenance treatment (MMT) has been one of the most effective treatment choices for opioid addicts to reduce their heroin use, criminality and spread of HIV. In Taiwan, MMT has been introduced since 2006. To date, more than 30,000 opioid addicts have ever participated in MMT, but only around 10,000 retains in treatment. Outcomes of the ever-treated MMT patients remain unclear. It is crucial to trace the opioid addicts' treatment career, outcomes and unmet treatment needs for the service providers to modify treatment strategy to help these individual to maintain abstinence. Moreover, understanding of the determinants for these subjects' long-term outcomes is important for policy makers to implement realistic policies to motivate the service providers and patients.

From the results of previous research, the research team found that early dropout, defined as stayed in-treatment less than one month, of MMT participants were 14.4%. The rate of maintaining in treatment at 3rd , 6th, and 12th month were 65.7%、51.3% and 33.8%, respectively. Average treatment days for 12-month is 186.9±141.2. This result showed that the effectiveness of the MMT was varied among different facilities. On the other hand, the quality of the MMT can be improved largely through different dimensions. Besides, if one participant can enhance its motivation in staying in-treatment, it could reduce 15% early dropout. Above all, the result also showed that though the quality of life was recorded as improved after MMT, it appeared to be significantly lower than their healthy counterparties. The assessments of health outcomes after participating MMT are rare, but in need. It is necessary to make some modification to improve the effectiveness. Moreover, the evaluation of the needs shall not limit to patients, but also extend to their family members.

Therefore, in this study, the research team plans to probe the dimensions from physical, psychiatric, to social conditions by assessing patients and their family members after treated by MMT for five years. The research team would like to know more about the outcomes of those who attended MMT five years ago, their physical and mental health conditions, also health status of their family members.

Condition or disease
Heroin Dependence Sleep Impairment Mortality Quality of Life Treatment Outcome

Study Type : Observational [Patient Registry]
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Target Follow-Up Duration: 1 Year
Official Title: Methadone Maintenance Outcome Study in Taiwan: 5-year Follow-up
Study Start Date : April 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. All cause mortality [ Time Frame: Five-year ]

Secondary Outcome Measures :
  1. Sleep impairment via Chinese version of the Pittsburgh Sleep Quality Index [ Time Frame: One month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We included participants in this current study from those who attended our three studies before (IRB approved ID: EC0980203, EC0980209, EC1010102).

Inclusion Criteria:

  • Attended EC0980203, EC0980209, EC1010102 projects
  • Nationality: Taiwan
  • 20-year-old and above
  • Match the diagnosis of heroin dependence from DSM-IV
  • Able to fill out the informed consent

Exclusion Criteria:

  • Acute major physical or mental illness (need immediate health care)

Responsible Party: National Health Research Institutes, Taiwan Identifier: NCT02524912     History of Changes
Other Study ID Numbers: NHRITaiwan
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents