Comparative Evaluation of PUSPENs and C&Cs

Terminated

• Conditions: Opioid-Related Disorders
• Interventions: Drug: Methadone

• Registration Number: NCT02698098
• Lead Sponsor: University of Malaya

Brief Summary

This observational study compares the health and social outcomes between opioid-dependent individuals who are either recently released from a compulsory drug detention center (CDDC) or recently discharged from a voluntary treatment center (VTC) providing methadone maintenance therapy, in Malaysia.

Detailed Description

In July 2010, the National Anti-Drug Agency of Malaysia (NADA) introduced a non-punitive system of treatment and care for people who use drugs, voluntary treatment centers (VTCs), called 'Cure \& Care' clinics, offering free methadone maintenance therapy (MMT) to opioid-dependent drug users. These centers were opened alongside existing compulsory drug detention centers (CDDCs), where people who use drugs continue to be detained involuntarily without access to evidence-based treatment. Given that both of these programs are operated by NADA but espouse vastly different responses to drug use, we compared health and social outcomes between opioid-dependent individuals recently released from CDDCs and recently initiated into MMT in the new VTCs.

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-02
• Study First Submitted: 2016-02-16
• Study First Submitted QC: 2016-02-28
• Last Update Submitted: 2016-02-28
• Study First Posted: 2016-03-03
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 281

Inclusion Criteria

• Meets Diagnostic and Statistical Manual-IV criteria for opioid dependence
• Physically and psychologically capable of understanding and undergoing informed consent process
• Within 90 days of release or discharge and intending to return to Klang Valley region
• For VTC arm, came to the C&C to start MMT

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Voluntary Treatment Center	Methadone	Voluntary drug treatment facilities, called 'Cure and Care' centers in Malaysia, that provide methadone maintenance therapy in addition to psychosocial interventions, recreational programming, and vocational training, among other activities.

Primary Outcome Measures

Name	Time	Method
Occurrence of opioid use (urine-toxicology)	Year following release from CDDC or discharge from VTC

Secondary Outcome Measures

Name	Time	Method
Occurrence of any drug use (urine-toxicology)	Year following release from CDDC or discharge from VTC	Includes opioid, amphetamine and benzodiazepine use
Occurrence of amphetamine use (urine-toxicology)	Year following release from CDDC or discharge from VTC
Occurrence of benzodiazepine use (urine-toxicology)	Year following release from CDDC or discharge from VTC
Occurrence of methadone use (urine-toxicology)	Year following release from CDDC or discharge from VTC	This is a proxy for linkage to methadone therapy
Occurrence of buprenorphine use (urine-toxicology)	Year following release from CDDC or discharge from VTC	This is a proxy for linkage to buprenorphine therapy
Occurrence of no-methadone use (urine-toxicology)	Year following release from CDDC or discharge from VTC	This is a proxy for retention in methadone therapy