Clinical trial NCT02698098: Comparative Evaluation of PUSPENs and C&Cs
Official title: Comparing Health & Social Outcomes Between Opioid-Dependent Individuals in Compulsory Drug Rehabilitation Centers and Voluntary Drug Treatment Clinics in Klang Valley, Malaysia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Opioid-Related Disorders
Keywords: Malaysia
Asia
Southeast Asia
Compulsory Drug Detention Centers
Compulsory Centers for Drug Users
Methadone
Drug Relapse
Drug and Narcotic Control
Opiate Substitution Treatment
Prisons
Lead sponsor: University of Malaya
Sponsor class: OTHER
Collaborators: name: Yale University
name: World Bank
name: Doris Duke Charitable Foundation
name: National Institute of Mental Health (NIMH)
name: The University of New South Wales
name: Burnet Institute
name: University of Florida
name: National Institute on Drug Abuse (NIDA)
First posted: 2016-03-03
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of opioid use (urine-toxicology)
timeFrame: Year following release from CDDC or discharge from VTC
Secondary outcomes:
measure: Occurrence of any drug use (urine-toxicology)
timeFrame: Year following release from CDDC or discharge from VTC
measure: Occurrence of amphetamine use (urine-toxicology)
timeFrame: Year following release from CDDC or discharge from VTC
measure: Occurrence of benzodiazepine use (urine-toxicology)
timeFrame: Year following release from CDDC or discharge from VTC
measure: Occurrence of methadone use (urine-toxicology)
timeFrame: Year following release from CDDC or discharge from VTC
measure: Occurrence of buprenorphine use (urine-toxicology)
timeFrame: Year following release from CDDC or discharge from VTC
measure: Occurrence of no-methadone use (urine-toxicology)
timeFrame: Year following release from CDDC or discharge from VTC
Other outcomes:
measure: Occurrence of drug or methadone use (self-report)
timeFrame: Year following release from CDDC or discharge from VTC
measure: Addiction Severity (self-report)
timeFrame: Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC
measure: Occurrence of non-fatal overdose (self-report)
timeFrame: Year following release from CDDC or discharge from VTC
measure: Rates of injection-related HIV risk behaviors (self report)
timeFrame: Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC
measure: Rates of sex-related HIV risk behaviors (self report)
timeFrame: Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC
measure: Opioid cravings (self report)
timeFrame: Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC
measure: Motivation to change drug use (self report)
timeFrame: Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC
measure: Police harassment (self report)
timeFrame: Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC
measure: Health-related quality of life (self report)
timeFrame: Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC
measure: Social Support (self report)
timeFrame: Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC
measure: Occurrence of HIV seroconversion (antibody test)
timeFrame: Year following release from CDDC or discharge from VTC
measure: Rates of employment (self report)
timeFrame: Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC
measure: Total monthly income (self report)
timeFrame: Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC
measure: Days of criminal activity (self report)
timeFrame: Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC
measure: Detention in CDDC/Incarceration in jail or prison
timeFrame: Year following release from CDDC or discharge from VTC
Locations:
Study officials:
affiliation: Yale University
name: Frederick Altice, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malaya
name: Adeeba Kamarulzaman, FRACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.