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Comparative Evaluation of PUSPENs and C&Cs (PSVCC)

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ClinicalTrials.gov Identifier: NCT02698098
Recruitment Status : Terminated (1) Policy change affecting C&Cs; 2) interm analysis revealing overt differences)
First Posted : March 3, 2016
Last Update Posted : March 3, 2016
Sponsor:
Collaborators:
Yale University
World Bank
Doris Duke Charitable Foundation
National Institute of Mental Health (NIMH)
The University of New South Wales
Burnet Institute
University of Florida
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Opioid-Related Disorders 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.

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Study Type : Observational
Actual Enrollment : 281 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : August 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Occurrence of opioid use (urine-toxicology) [ Time Frame: Year following release from CDDC or discharge from VTC ]

Secondary Outcome Measures :
  1. Occurrence of any drug use (urine-toxicology) [ Time Frame: Year following release from CDDC or discharge from VTC ]
    Includes opioid, amphetamine and benzodiazepine use

  2. Occurrence of amphetamine use (urine-toxicology) [ Time Frame: Year following release from CDDC or discharge from VTC ]
  3. Occurrence of benzodiazepine use (urine-toxicology) [ Time Frame: Year following release from CDDC or discharge from VTC ]
  4. Occurrence of methadone use (urine-toxicology) [ Time Frame: Year following release from CDDC or discharge from VTC ]
    This is a proxy for linkage to methadone therapy

  5. Occurrence of buprenorphine use (urine-toxicology) [ Time Frame: Year following release from CDDC or discharge from VTC ]
    This is a proxy for linkage to buprenorphine therapy

  6. Occurrence of no-methadone use (urine-toxicology) [ Time Frame: Year following release from CDDC or discharge from VTC ]
    This is a proxy for retention in methadone therapy


Other Outcome Measures:
  1. Occurrence of drug or methadone use (self-report) [ Time Frame: Year following release from CDDC or discharge from VTC ]
    Sub-measures include opioid use, any drug use (opioid, amphetamine, benzodiazepine), methadone use, buprenorphine use

  2. Addiction Severity (self-report) [ Time Frame: Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC ]
  3. Occurrence of non-fatal overdose (self-report) [ Time Frame: Year following release from CDDC or discharge from VTC ]
  4. Rates of injection-related HIV risk behaviors (self report) [ Time Frame: Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC ]
  5. Rates of sex-related HIV risk behaviors (self report) [ Time Frame: Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC ]
  6. Opioid cravings (self report) [ Time Frame: Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC ]
  7. Motivation to change drug use (self report) [ Time Frame: Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC ]
  8. Police harassment (self report) [ Time Frame: Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC ]
  9. Health-related quality of life (self report) [ Time Frame: Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC ]
  10. Social Support (self report) [ Time Frame: Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC ]
  11. Occurrence of HIV seroconversion (antibody test) [ Time Frame: Year following release from CDDC or discharge from VTC ]
  12. Rates of employment (self report) [ Time Frame: Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC ]
  13. Total monthly income (self report) [ Time Frame: Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC ]
  14. Days of criminal activity (self report) [ Time Frame: Compared at 3, 6, 9 and 12-months following release from CDDC or discharge from VTC ]
  15. Detention in CDDC/Incarceration in jail or prison [ Time Frame: Year following release from CDDC or discharge from VTC ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698098


Sponsors and Collaborators
University of Malaya
Yale University
World Bank
Doris Duke Charitable Foundation
National Institute of Mental Health (NIMH)
The University of New South Wales
Burnet Institute
University of Florida
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Frederick Altice, MD Yale University
Principal Investigator: Adeeba Kamarulzaman, FRACP University of Malaya
Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Malaya
ClinicalTrials.gov Identifier: NCT02698098    
Other Study ID Numbers: 1206010403
F30MH105153 ( U.S. NIH Grant/Contract )
K24DA017072 ( U.S. NIH Grant/Contract )
R01DA025943 ( U.S. NIH Grant/Contract )
HIRGA E000001-20001 ( Other Identifier: Malaysian Ministry of Education (High Impact Research Grant) )
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: See links at end of this record for accessing de-identified data and documentation.
Keywords provided by University of Malaya:
Malaysia
Asia
Southeast Asia
Compulsory Drug Detention Centers
Compulsory Centers for Drug Users
Methadone
Drug Relapse
Drug and Narcotic Control
Opiate Substitution Treatment
Prisons
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents