NCT03071315

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
522

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 20, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2017

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

February 28, 2017

Last Update Submit

March 9, 2017

Conditions

Keywords

Economic evaluationHeroin dependenceCompulsory treatmentMethadone treatmentVietnamEast and Southeast AsiaCost-effectiveness

Outcome Measures

Primary Outcomes (1)

  • Heroin abstinence

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

    Preceding 3 months and 30 days

Secondary Outcomes (5)

  • Drug-free days

    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

    Preceding 3 months and 30 days

  • Overdose incidents

    Preceding 3 months and 30 days

  • Monthly drug spending

    Preceding 3 months and 30 days

Study Arms (2)

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.

Other: CCT

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.

Other: MMT

Interventions

CCTOTHER

CCT focuses on behavioral approach, mainly punitive punishment measures.

CCT participants
MMTOTHER

MMT is a combination of pharmaceutical and behavioral intervention.

MMT participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Study site in Vietnam

Haiphong, Hai Phong, 10000, Vietnam

Location

Related Publications (1)

  • Vuong T, Ritter A, Shanahan M, Ali R, Nguyen N, Pham K, Vuong TTA, Le GM. Outcomes of compulsory detention compared to community-based voluntary methadone maintenance treatment in Vietnam. J Subst Abuse Treat. 2018 Apr;87:9-15. doi: 10.1016/j.jsat.2018.01.011. Epub 2018 Jan 16.

MeSH Terms

Conditions

Heroin Dependence

Interventions

2-methylcyclopentadienyl manganese tricarbonyl

Condition Hierarchy (Ancestors)

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

Study Officials

  • Alison Ritter, PhD

    The University of New South Wales

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 28, 2017

First Posted

March 6, 2017

Study Start

January 20, 2013

Primary Completion

January 30, 2015

Study Completion

January 30, 2015

Last Updated

March 13, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations