Opioid-Related DisordersPSVCCNCT02698098
Comparative Evaluation of PUSPENs and C&Cs
An observational study of Opioid-Related Disorders, run by University of Malaya.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-Related Disorders
- What is being tested?
- Methadone
- How many people
- 281 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
About this study
Official title: 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.
Read the 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.
- Conditions
- Opioid-Related Disorders
- Being tested
- Methadone
- 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
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of opioid use (urine-toxicology)
Measured: Year following release from CDDC or discharge from VTC
Secondary outcomes (6)
Occurrence of any drug use (urine-toxicology)
Includes opioid, amphetamine and benzodiazepine use
Measured: Year following release from CDDC or discharge from VTC
Occurrence of amphetamine use (urine-toxicology)
Measured: Year following release from CDDC or discharge from VTC
Occurrence of benzodiazepine use (urine-toxicology)
Measured: Year following release from CDDC or discharge from VTC
Occurrence of methadone use (urine-toxicology)
This is a proxy for linkage to methadone therapy
Measured: Year following release from CDDC or discharge from VTC
Occurrence of buprenorphine use (urine-toxicology)
This is a proxy for linkage to buprenorphine therapy
Measured: 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
Measured: Year following release from CDDC or discharge from VTC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startAug 2012
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: 1\) Policy change affecting C\&Cs; 2) interm analysis revealing overt differences
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- 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)
- Responsible party
- Sponsor
- Investigators
- Frederick Altice, MD, Principal investigator, Yale UniversityAdeeba Kamarulzaman, FRACP, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698098
- Sponsor's protocol ID
- 1206010403
- Other IDs
- F30MH105153, K24DA017072, R01DA025943, HIRGA E000001-20001
- Acronym
- PSVCC
- Status last verified
- Feb 2016
- First submitted
- 16 Feb 2016
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: See links at end of this record for accessing de-identified data and documentation.
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.
PubMed 27964869
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Health & Social Outcomes Between Opioid-Dependent Individuals in Compulsory Drug Rehabilitation Centers and Voluntary Drug Treatment Clinics in Klang Valley, Malaysia
- ClinicalTrials.gov ID
- NCT02698098
- Acronym / sponsor ID
- PSVCC / 1206010403
- 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
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: 1\) Policy change affecting C\&Cs; 2) interm analysis revealing overt differences
- Enrolment
- 281 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- 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)
- Study start
- Aug 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Drug: MethadoneVoluntary 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methadone | Drug | Voluntary Treatment Center |
Primary outcome
Occurrence of opioid use (urine-toxicology)
Time frame: Year following release from CDDC or discharge from VTC
6 secondary outcomes
Occurrence of any drug use (urine-toxicology)
Time frame: Year following release from CDDC or discharge from VTC
Occurrence of amphetamine use (urine-toxicology)
Time frame: Year following release from CDDC or discharge from VTC
Occurrence of benzodiazepine use (urine-toxicology)
Time frame: Year following release from CDDC or discharge from VTC
Occurrence of methadone use (urine-toxicology)
Time frame: Year following release from CDDC or discharge from VTC
Occurrence of buprenorphine use (urine-toxicology)
Time frame: Year following release from CDDC or discharge from VTC
Occurrence of no-methadone use (urine-toxicology)
Time frame: Year following release from CDDC or discharge from VTC
Results and safety
The study was stopped early (reason given: 1\) Policy change affecting C\&Cs; 2) interm analysis revealing overt differences). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
- Derived from this study: PubMed 27964869Wegman 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.
- Link to dataverse site with protocol, study questionnaires, individual de-identified data and analytic codeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. See links at end of this record for accessing de-identified data and documentation.
Related trials for Opioid-Related Disorders
RecruitingPhase 2
Targeting Treatment-Resistant OUD With Ketamine-Assisted Mindfulness Oriented Recovery Enhancement
Opioid Use Disorder
Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
Active, not recruitingPhase 3
Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain: A Pilot Double-Blind, Randomized Control Trial
Misuse, Opioid
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
RecruitingEarly Phase 1
Evaluating Pain Control Strategies in Postpartum Patients on Opioid Use Disorder Medications.
Substance Use Disorder (SUD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick Altice, MD principal investigator
Yale University
Adeeba Kamarulzaman, FRACP principal investigator
University of Malaya
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-Related Disorders, run by University of Malaya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 1\) Policy change affecting C\&Cs; 2) interm analysis revealing overt differences). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of opioid use (urine-toxicology) (time frame: Year following release from CDDC or discharge from VTC). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02698098, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2016.