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

Heroin Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03071315
• Other study ID #: HC12259
• Status: Completed
• Phase: N/A
• First received: February 28, 2017
• Last updated: March 9, 2017
• Start date: January 20, 2013
• Est. completion date: January 30, 2015

Study information

• Verified date: March 2017
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 522
• Est. completion date: January 30, 2015
• Est. primary completion date: January 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heroin Dependence

Intervention

Other:
• CCT
CCT focuses on behavioral approach, mainly punitive punishment measures.
• MMT
MMT is a combination of pharmaceutical and behavioral intervention.

Locations

Country	Name	City	State
Vietnam	Study site in Vietnam	Hai Phong

Sponsors (5)

Lead Sponsor	Collaborator
The University of New South Wales	FHI 360, Hanoi Medical University, The Atlantic Philanthropies, University of Adelaide

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heroin abstinence	Free from heroin use (self-reported), confirmed by urine drug screening on interview day.	Preceding 3 months and 30 days
Secondary	Drug-free days	Days without use of any illicit drugs (self-report)	Preceding 3 months and 30 days
Secondary	Drug-use related illegal behaviors	Drug-use related illegal behaviors	Preceding 3 months and 30 days
Secondary	Drug-use related blood-borne virus (BBV) risk behaviors	Drug-use related blood-borne virus (BBV) risk behaviors	Preceding 3 months and 30 days
Secondary	Overdose incidents	Overdose incidents	Preceding 3 months and 30 days
Secondary	Monthly drug spending	Monthly drug spending	Preceding 3 months and 30 days