Heroin DependenceNCT02524912
Methadone Maintenance Outcome Study in Taiwan: 5-year Follow-up
An observational study of Heroin Dependence and Sleep Impairment, run by National Health Research Institutes, Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heroin Dependence, Sleep Impairment, Mortality
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Mar 2017
- How long will I take part?
- 1 Year
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We included participants in this current study from those who attended our three studies before (IRB approved ID: EC0980203, EC0980209, EC1010102).
Who may be able to join
- 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
Who cannot join
- Acute major physical or mental illness (need immediate health care)
About this study
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.
- Medical subject headings
- Heroin Dependence
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: Five-year
Secondary outcomes (1)
Sleep impairment via Chinese version of the Pittsburgh Sleep Quality Index
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heroin DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524912
- Sponsor's protocol ID
- NHRITaiwan
- Status last verified
- Sep 2015
- First submitted
- 12 Aug 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methadone Maintenance Outcome Study in Taiwan: 5-year Follow-up
- ClinicalTrials.gov ID
- NCT02524912
- Acronym / sponsor ID
- NHRITaiwan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We included participants in this current study from those who attended our three studies before (IRB approved ID: EC0980203, EC0980209, EC1010102).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Acute major physical or mental illness (need immediate health care)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All cause mortality
Time frame: Five-year
1 secondary outcome
Sleep impairment via Chinese version of the Pittsburgh Sleep Quality Index
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Heroin Dependence and Sleep Impairment, run by National Health Research Institutes, 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 5 inclusion and 1 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 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: Five-year). It is what the study was designed to measure, not a finding.
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 20 Nov 2015.