Comparative Evaluation of PUSPENs and C&Cs

NCT02698098 | Terminated

• 5 other identifiers: 1206010403F30MH105153K24DA017072R01DA025943HIRGA E000001-20001
• Study Type: observational
• Target: 281
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Occurrence of opioid use (urine-toxicology)

  Year following release from CDDC or discharge from VTC

Secondary Outcomes (6)

• Occurrence of any drug use (urine-toxicology)

  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)

  Year following release from CDDC or discharge from VTC

• Occurrence of buprenorphine use (urine-toxicology)

  Year following release from CDDC or discharge from VTC

Other Outcomes (15)

• Occurrence of drug or methadone use (self-report)

  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

Study Arms (2)

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

Interventions

Methadone DRUG

Voluntary Treatment Center

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead
• Yale University: collaborator
• World Bank: collaborator
• Doris Duke Charitable Foundation: collaborator
• National Institute of Mental Health (NIMH): collaborator
• The University of New South Wales: collaborator
• Burnet Institute: collaborator
• University of Florida: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Related Publications (1)

• 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.

  PMID: 27964869 DERIVED

Related Links

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

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Methadone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Frederick Altice, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Adeeba Kamarulzaman, FRACP

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: March 3, 2016
• Study Start: August 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 3, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share