NCT02524912

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

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

April 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

November 20, 2015

Status Verified

September 1, 2015

Enrollment Period

1.9 years

First QC Date

August 12, 2015

Last Update Submit

November 18, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    Five-year

Secondary Outcomes (1)

  • Sleep impairment via Chinese version of the Pittsburgh Sleep Quality Index

    One month

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heroin Dependence

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2015

First Posted

August 17, 2015

Study Start

April 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

November 20, 2015

Record last verified: 2015-09