Drug Counseling and Abstinent-Contingent Take-Home Buprenorphine in Malaysia
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ClinicalTrials.gov Identifier: NCT00539123 |
Recruitment Status
: Unknown
Verified June 2009 by Yale University.
Recruitment status was: Recruiting
First Posted
: October 4, 2007
Last Update Posted
: June 4, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Opiate Dependence | Behavioral: behavioral drug and HIV risk reduction counseling (BDRC) Behavioral: abstinence-contingent take-home buprenorphine (ACB) Behavioral: Physician Management (PM) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Drug Counseling and Abstinent-Contingent Take-Home Buprenorphine in Malaysia |
Study Start Date : | September 2007 |
Estimated Primary Completion Date : | September 2012 |
Estimated Study Completion Date : | September 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Physician Management (PM): medically focused advice and brief counseling
|
Behavioral: Physician Management (PM)
medically focused advice and brief counseling
|
Experimental: 2
Physician Management (PM) plus Abstinence Contingent Buprenorphine (ACB) dispensing
|
Behavioral: abstinence-contingent take-home buprenorphine (ACB)
Patients achieving heroin abstinence receive take-home doses of buprenorphine
Behavioral: Physician Management (PM)
medically focused advice and brief counseling
|
Experimental: 3
PM plus Behavioral Drug and HIV Risk Reduction Counseling (BDRC)
|
Behavioral: behavioral drug and HIV risk reduction counseling (BDRC)
BDRC utilizes short-term behavioral contracts to promote abstinence and reduce drug- and sex-related HIV risk behaviors and can be provided by nurses and medical assistants available in medical settings in Malaysia.
Behavioral: Physician Management (PM)
medically focused advice and brief counseling
|
Experimental: 4
PM plus BDRC plus ACB
|
Behavioral: behavioral drug and HIV risk reduction counseling (BDRC)
BDRC utilizes short-term behavioral contracts to promote abstinence and reduce drug- and sex-related HIV risk behaviors and can be provided by nurses and medical assistants available in medical settings in Malaysia.
Behavioral: abstinence-contingent take-home buprenorphine (ACB)
Patients achieving heroin abstinence receive take-home doses of buprenorphine
Behavioral: Physician Management (PM)
medically focused advice and brief counseling
|
- reductions in heroin use [ Time Frame: 26 weeks ]
- reductions in drug- and sex-related HIV risk [ Time Frame: 26 weeks ]
- retention [ Time Frame: 26 weeks ]
- reductions in other illicit drug use [ Time Frame: 26 weeks ]
- changes in functional status [ Time Frame: 26 weeks ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- opioid dependence
Exclusion Criteria:
- current dependence on alcohol, benzodiazepines or sedatives current suicide or homicide risk current psychotic disorder or major depression inability to understand protocol or assessment questions life threatening or unstable medical problems more than 3x normal liver enzymes

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): NCT00539123
Contact: Mahmud Mazlan, MD | 60-6-953-2291 | melaun@yahoo.com |
United States, Connecticut | |
Yale University School of Medicine | Active, not recruiting |
New Haven, Connecticut, United States, 06519 | |
Malaysia | |
Substance Abuse Research Center | Recruiting |
Muar, Johor, Malaysia, 84000 |
Principal Investigator: | Richard S. Schottenfeld, MD | Yale University | |
Study Director: | Mahmud Mazlan, MD | Substance Abuse Research Center, Muar |
Responsible Party: | Richard S. Schottenfeld, MD, Yale University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00539123 History of Changes |
Other Study ID Numbers: |
2R01DA014718-05A1 ( U.S. NIH Grant/Contract ) |
First Posted: | October 4, 2007 Key Record Dates |
Last Update Posted: | June 4, 2009 |
Last Verified: | June 2009 |
Keywords provided by Yale University:
buprenorphine drug counseling HIV risk reduction counseling |
Additional relevant MeSH terms:
Opioid-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Buprenorphine Analgesics, Opioid Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists |