Comparative Evaluation of PUSPENs and C&Cs (PSVCC)

Comparing Health & Social Outcomes Between Opioid-Dependent Individuals in Compulsory Drug Rehabilitation Centers and Voluntary Drug Treatment Clinics in Klang Valley, Malaysia

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.

Study Overview

• Status: Terminated
• Conditions: Opioid-Related Disorders
• Intervention / Treatment: Drug: Methadone

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 Type: Observational
• Enrollment (Actual): 281

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted among opioid-dependent individuals initiating MMT in C&C Centers and opioid-dependent individuals being released from Pusat Serenti who consent to participating in the study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Compulsory Drug Detention Center; Conventional drug treatment in Malaysia and Southeast Asia including detention for an average of 2 years, including educational and job skills programs and physical education. Medical therapies for treating substance use disorders, such as opioid-agonist treatment (OAT), are unavailable.
Voluntary Treatment Center; 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.	Drug: Methadone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of opioid use (urine-toxicology)	Year following release from CDDC or discharge from VTC

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of drug or methadone use (self-report)	Sub-measures include opioid use, any drug use (opioid, amphetamine, benzodiazepine), methadone use, buprenorphine use	Year following release from CDDC or discharge from VTC
Addiction Severity (self-report)		Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC
Occurrence of non-fatal overdose (self-report)		Year following release from CDDC or discharge from VTC
Rates of injection-related HIV risk behaviors (self report)		Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC
Rates of sex-related HIV risk behaviors (self report)		Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC
Opioid cravings (self report)		Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC
Motivation to change drug use (self report)		Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC
Police harassment (self report)		Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC
Health-related quality of life (self report)		Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC
Social Support (self report)		Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC
Occurrence of HIV seroconversion (antibody test)		Year following release from CDDC or discharge from VTC
Rates of employment (self report)		Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC
Total monthly income (self report)		Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC
Days of criminal activity (self report)		Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC
Detention in CDDC/Incarceration in jail or prison		Year following release from CDDC or discharge from VTC

Collaborators and Investigators

• Sponsor: University of Malaya
• Collaborators: National Institute on Drug Abuse (NIDA); National Institute of Mental Health (NIMH); Yale University; University of Florida; Burnet Institute; World Bank; The University of New South Wales; Doris Duke Charitable Foundation
• Investigators: Principal Investigator: Adeeba Kamarulzaman, FRACP, University of Malaya

Publications and helpful links

General Publications

• Wegman MP, Altice FL, Kaur S, Rajandaran V, Osornprasop S, Wilson D, Wilson DP, Kamarulzaman A. Relapse to opioid use in opioid-dependent individuals released from compulsory drug detention centres compared with those from voluntary methadone treatment centres in Malaysia: a two-arm, prospective observational study. Lancet Glob Health. 2017 Feb;5(2):e198-e207. doi: 10.1016/S2214-109X(16)30303-5. Epub 2016 Dec 8.

Helpful Links

• Link to dataverse site with protocol, study questionnaires, individual de-identified data and analytic code

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: February 16, 2016
• First Submitted That Met QC Criteria: February 28, 2016
• First Posted (Estimate): March 3, 2016

Study Record Updates

• Last Update Posted (Estimate): March 3, 2016
• Last Update Submitted That Met QC Criteria: February 28, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Methadone; Asia; Opiate Substitution Treatment; Drug Relapse; Southeast Asia; Malaysia; Prisons; Compulsory Drug Detention Centers; Compulsory Centers for Drug Users; Drug and Narcotic Control
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Methadone
• Other Study ID Numbers: 1206010403; R01DA025943 (U.S. NIH Grant/Contract); F30MH105153 (U.S. NIH Grant/Contract); K24DA017072 (U.S. NIH Grant/Contract); HIRGA E000001-20001 (Other Identifier: Malaysian Ministry of Education (High Impact Research Grant))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: See links at end of this record for accessing de-identified data and documentation.

Study Data/Documents

1. Study Protocol
2. Individual Participant Data Set
3. Analytic Code