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Completed

NCT Number: NCT03071315

Economic Evaluation Comparing CCT With MMT 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Study site in Vietnam

Haiphong, Hai Phong, 10000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CCT

Other

CCT focuses on behavioral approach, mainly punitive punishment measures.

MMT

Other

MMT is a combination of pharmaceutical and behavioral intervention.

Primary outcomes

  1. Heroin abstinence

    Time frame: Preceding 3 months and 30 days

    Free from heroin use (self-reported), confirmed by urine drug screening on interview day.

Secondary outcomes

  1. Drug-free days

    Time frame: Preceding 3 months and 30 days

    Days without use of any illicit drugs (self-report)

  2. Drug-use related illegal behaviors

    Time frame: Preceding 3 months and 30 days

    Drug-use related illegal behaviors

  3. 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

  4. Overdose incidents

    Time frame: Preceding 3 months and 30 days

    Overdose incidents

  5. Monthly drug spending

    Time frame: Preceding 3 months and 30 days

    Monthly drug spending

Sponsors and collaborators

Lead sponsor

The University of New South Wales

Other

Collaborators

  • FHI 360
  • Hanoi Medical University
  • The Atlantic Philanthropies
  • University of Adelaide

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 6, 2017
Registry last updated
Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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