Heroin DependenceNCT03071315
Economic Evaluation Comparing CCT With MMT in Hai Phong City, Vietnam
An observational study of Heroin Dependence, run by The University of New South Wales at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heroin Dependence
- What is being tested?
- CCT and MMT
- How many people
- 522 participants
- Where
- 1 siteVietnam
- Study dates
- 20 Jan 2013to 30 Jan 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
- 18 years of age and older
Show all 9Show fewer
- 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.
Who cannot join
- Younger than 18 years old
- Severe cognitive or mental impairment
- Unable to grant consent for this research study
- Non-dependent use of heroin.
- Younger than 18 years old
- Severe cognitive or mental impairment
- Unable to grant consent for this research study
- Non-dependent use of heroin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Heroin Dependence
- Being tested
- CCT, MMT
- Keywords
- Economic evaluation, Heroin dependence, Compulsory treatment, Methadone treatment, Vietnam, East and Southeast Asia, Cost-effectiveness
- Medical subject headings
- Heroin Dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCTOther
CCT focuses on behavioral approach, mainly punitive punishment measures.
MMTOther
MMT is a combination of pharmaceutical and behavioral intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: MMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heroin abstinence
Free from heroin use (self-reported), confirmed by urine drug screening on interview day.
Measured: Preceding 3 months and 30 days
Secondary outcomes (5)
Drug-free days
Days without use of any illicit drugs (self-report)
Measured: Preceding 3 months and 30 days
Drug-use related illegal behaviors
Drug-use related illegal behaviors
Measured: Preceding 3 months and 30 days
Drug-use related blood-borne virus (BBV) risk behaviors
Drug-use related blood-borne virus (BBV) risk behaviors
Measured: Preceding 3 months and 30 days
Overdose incidents
Overdose incidents
Measured: Preceding 3 months and 30 days
Monthly drug spending
Monthly drug spending
Measured: Preceding 3 months and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start20 Jan 2013
- Primary completion30 Jan 2015
- Study completion30 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Time perspective
- Prospective
- Enrolment
- 522 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Collaborators
- The Atlantic Philanthropies, FHI 360, Hanoi Medical University, University of Adelaide
- Responsible party
- Principal investigator, Alison Ritter, The University of New South Wales
- Investigators
- Alison Ritter, PhD, Principal investigator, The University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071315
- Sponsor's protocol ID
- HC12259
- Status last verified
- Mar 2017
- First submitted
- 28 Feb 2017
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29471930
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Evaluation Comparing Center-based Compulsory Drug Treatment With Community-based Methadone Maintenance Treatment in Hai Phong City, Vietnam
- ClinicalTrials.gov ID
- NCT03071315
- Acronym / sponsor ID
- HC12259
- Conditions
- Heroin Dependence
- Keywords
- Economic evaluation, Heroin dependence, Compulsory treatment, Methadone treatment, Vietnam, East and Southeast Asia, Cost-effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 522 participants (actual)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Collaborators
- The Atlantic Philanthropies, FHI 360, Hanoi Medical University, University of Adelaide
- Study start
- 20 Jan 2013 (actual)
- Primary completion
- 30 Jan 2015 (actual)
- Study completion
- 30 Jan 2015 (actual)
- First posted
- 6 Mar 2017 (actual)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCT participants | – | Other: CCTCenter-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. |
| MMT participants | – | Other: MMTMethadone 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- Younger than 18 years old
- Severe cognitive or mental impairment
- Unable to grant consent for this research study
- Non-dependent use of heroin.
- Younger than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCTCCT focuses on behavioral approach, mainly punitive punishment measures. | Other | CCT participants |
| MMTMMT is a combination of pharmaceutical and behavioral intervention. | Other | MMT participants |
Primary outcome
Heroin abstinence
Time frame: Preceding 3 months and 30 days
Free from heroin use (self-reported), confirmed by urine drug screening on interview day.
5 secondary outcomes
Drug-free days
Time frame: Preceding 3 months and 30 days
Drug-use related illegal behaviors
Time frame: Preceding 3 months and 30 days
Drug-use related blood-borne virus (BBV) risk behaviors
Time frame: Preceding 3 months and 30 days
Overdose incidents
Time frame: Preceding 3 months and 30 days
Monthly drug spending
Time frame: Preceding 3 months and 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Derived from this study: PubMed 29471930Vuong 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.
- Individual participant dataSharing planned: No
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.
Alison Ritter, PhD principal investigator
The University of New South Wales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heroin Dependence, run by The University of New South Wales at 1 site in Vietnam.
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 9 inclusion and 8 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: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Heroin abstinence (time frame: Preceding 3 months and 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03071315, which also lists 1 linked publication.
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 13 Mar 2017.