An observational study in Heroin Dependence, sponsored by The University of New South Wales. Completed at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-13.
Sponsored by The University of New South Wales · Observational
The study compared the effectiveness and cost-effectiveness of two dominant heroin dependence treatment approaches: center-based compulsory rehabilitation (CCT) and community-based voluntary methadone treatment (MMT) in Hai Phong City, Vietnam. The design was a combined retrospective and prospective, non-randomized cohort over three years (with data at five time-points). The study was conducted between 2012 and 2015, involving 208 CCT participants and 384 MMT participants with heroin dependence.
The study compared the effectiveness and cost-effectiveness of two dominant heroin dependence treatment approaches: center-based compulsory rehabilitation (CCT) and community-based voluntary methadone treatment (MMT) in Hai Phong City, Vietnam. CCT centers are institutions in which people who use drugs are confined for two years. MMT has been internationally recognized as an efficacious treatment for heroin dependence and was introduced in Vietnam in 2008.
The design was combined retrospective and prospective, non-randomized cohort over three years (with data at five time-points). The study was conducted between 2012 and 2014, involving 208 CCT participants (of which 80% were followed up) and 384 MMT participants (of which 78% were followed up) with heroin dependence. The five time-points were: baseline, two years after treatment commencement, then three months, six months and 12 months after the initial two years. The study combined primary data and secondary data to assess the effectiveness of the two treatment modalities. The economic component measured the costs of the two treatment modalities to compare cost-effectiveness outcomes.
The study had two primary outcomes: self-reported heroin abstinence (confirmed by urine drug screening) and self-reported drug-free days (DFDs). DFDs was reported in two different time-frames. DFDs in the preceding 30 days was used for effectiveness comparison and DFDs over three years was used for the cost-effectiveness comparison. The study has four secondary outcomes: illegal behaviors, overdose, blood-borne virus (BBV) risk behaviors, and monthly drug spending).
Mixed effects regression models were used to analyze the effectiveness data and non-parametric bootstrapping methods were used to estimate cost-effectiveness. The time-frame for the cost-effectiveness analysis was three years.
90 studies on the registry are indexed under Heroin Dependence; 1 is open to participants now.
This study's enrollment of 522 is above the median of 30 across 17 observational studies indexed under Heroin Dependence.
Browse Heroin Dependence studies →The University of New South Wales is the lead sponsor of 66 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
CCT Participants: Participants who were placed in three CCT centers in Hai Phong City for 2 years (2011-2013) and agreed to voluntarily participate in this study (from July 2013: 12 months community follow-up).
MMT Participants: Participants who have participated in a previous cohort study (two-years:2009-2012) and agreed to voluntarily participate in this study (from 2013: an addition of 12 months)
Inclusion Criteria (for CCT Participants):
Exclusion Criteria (for CCT Participants):
Inclusion Criteria (for MMT Participants):
Exclusion Criteria (for MMT Participants):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Center-based compulsory treatment (CCT) participants who were placed into compulsory treatment centers for two years for a range of punitive treatment such as education, moral teaching, labor work. Very basic health care is provided in the CCT centers.
Other: CCT
Methadone maintenance treatment (MMT) participants who have been receiving MMT treatment. In Hai Phong City, during the period of this study, voluntary MMT was provided in the community free for people who were assessed as dependent on heroin.
Other: MMT
CCT focuses on behavioral approach, mainly punitive punishment measures.
MMT is a combination of pharmaceutical and behavioral intervention.
Heroin abstinence
Free from heroin use (self-reported), confirmed by urine drug screening on interview day.
Time frame: Preceding 3 months and 30 days
Drug-free days
Days without use of any illicit drugs (self-report)
Time frame: Preceding 3 months and 30 days
Drug-use related illegal behaviors
Drug-use related illegal behaviors
Time frame: Preceding 3 months and 30 days
Drug-use related blood-borne virus (BBV) risk behaviors
Drug-use related blood-borne virus (BBV) risk behaviors
Time frame: Preceding 3 months and 30 days
Overdose incidents
Overdose incidents
Time frame: Preceding 3 months and 30 days
Monthly drug spending
Monthly drug spending
Time frame: Preceding 3 months and 30 days
Plan to share: No
Ran from Jan 2013 to primary completion in Jan 2015, 24 months.
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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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The University of New South Wales