Comparative Evaluation of PUSPENs and C&Cs

Opioid-Related Disorders Clinical Trial

— PSVCC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02698098
• Other study ID #: 1206010403
• Secondary ID: F30MH105153K24DA
• Status: Terminated
• Phase: N/A
• First received: February 16, 2016
• Last updated: February 28, 2016
• Start date: August 2012
• Est. completion date: September 2015

Study information

• Verified date: February 2016
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review BoardUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 281
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

Drug:
• Methadone

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
University of Malaya	Burnet Institute, Doris Duke Charitable Foundation, National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA), The University of New South Wales, University of Florida, World Bank, Yale University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Addiction Severity (self-report)		Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC	No
Other	Occurrence of non-fatal overdose (self-report)		Year following release from CDDC or discharge from VTC	No
Other	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	No
Other	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	No
Other	Opioid cravings (self report)		Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC	No
Other	Motivation to change drug use (self report)		Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC	No
Other	Police harassment (self report)		Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC	No
Other	Health-related quality of life (self report)		Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC	No
Other	Social Support (self report)		Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC	No
Other	Occurrence of HIV seroconversion (antibody test)		Year following release from CDDC or discharge from VTC	No
Other	Rates of employment (self report)		Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC	No
Other	Total monthly income (self report)		Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC	No
Other	Days of criminal activity (self report)		Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC	No
Other	Detention in CDDC/Incarceration in jail or prison		Year following release from CDDC or discharge from VTC	No
Primary	Occurrence of opioid use (urine-toxicology)		Year following release from CDDC or discharge from VTC	No
Secondary	Occurrence of any drug use (urine-toxicology)	Includes opioid, amphetamine and benzodiazepine use	Year following release from CDDC or discharge from VTC	No
Secondary	Occurrence of amphetamine use (urine-toxicology)		Year following release from CDDC or discharge from VTC	No
Secondary	Occurrence of benzodiazepine use (urine-toxicology)		Year following release from CDDC or discharge from VTC	No
Secondary	Occurrence of methadone use (urine-toxicology)	This is a proxy for linkage to methadone therapy	Year following release from CDDC or discharge from VTC	No
Secondary	Occurrence of buprenorphine use (urine-toxicology)	This is a proxy for linkage to buprenorphine therapy	Year following release from CDDC or discharge from VTC	No
Secondary	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	No

External Links

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