Economic Evaluation Comparing CCT With MMT in Hai Phong City, Vietnam

March 9, 2017 updated by: Alison Ritter, The University of New South Wales

Economic Evaluation Comparing Center-based Compulsory Drug Treatment With Community-based Methadone Maintenance Treatment in Hai Phong City, Vietnam

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

522

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hai Phong, Vietnam, 10000
        • Study site in Vietnam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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)

Description

Inclusion Criteria (for CCT Participants):

  • 18 years of age and older
  • Heroin dependent
  • CCT-released participants who were rehabilitated in the CCT centers under the compulsory track.
  • CCT-released participants who received the recruitment letter sent by CCT centers' staff and who could provide either the recruitment letter or a certificate of CCT treatment completion at the time of first contact with a researcher as a proof that they were newly CCT-released participants.
  • Consented voluntarily to participate in the study, as assessed and determined by the researcher providing the informed consent documentation.

Exclusion Criteria (for CCT Participants):

  • Younger than 18 years old
  • Severe cognitive or mental impairment
  • Unable to grant consent for this research study
  • Non-dependent use of heroin.

Inclusion Criteria (for MMT Participants):

  • 18 years of age and older
  • Heroin dependence, measured by self-reported daily use of heroin during 3 months prior to index treatment, a proxy to measure heroin dependence
  • Participated in MMT treatment in Hai Phong City from 2008-2009
  • Consented voluntarily to participate in this research, as assessed and determined by the researcher providing the informed consent documentation.

Exclusion Criteria (for MMT Participants):

  • Younger than 18 years old
  • Severe cognitive or mental impairment
  • Unable to grant consent for this research study
  • Non-dependent use of heroin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CCT participants
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.
CCT focuses on behavioral approach, mainly punitive punishment measures.
MMT participants
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.
MMT is a combination of pharmaceutical and behavioral intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heroin abstinence
Time Frame: Preceding 3 months and 30 days
Free from heroin use (self-reported), confirmed by urine drug screening on interview day.
Preceding 3 months and 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug-free days
Time Frame: Preceding 3 months and 30 days
Days without use of any illicit drugs (self-report)
Preceding 3 months and 30 days
Drug-use related illegal behaviors
Time Frame: Preceding 3 months and 30 days
Drug-use related illegal behaviors
Preceding 3 months and 30 days
Drug-use related blood-borne virus (BBV) risk behaviors
Time Frame: Preceding 3 months and 30 days
Drug-use related blood-borne virus (BBV) risk behaviors
Preceding 3 months and 30 days
Overdose incidents
Time Frame: Preceding 3 months and 30 days
Overdose incidents
Preceding 3 months and 30 days
Monthly drug spending
Time Frame: Preceding 3 months and 30 days
Monthly drug spending
Preceding 3 months and 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alison Ritter, PhD, The University of New South Wales

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 20, 2013

Primary Completion (ACTUAL)

January 30, 2015

Study Completion (ACTUAL)

January 30, 2015

Study Registration Dates

First Submitted

February 28, 2017

First Submitted That Met QC Criteria

February 28, 2017

First Posted (ACTUAL)

March 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 13, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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