HIV Risk Reduction and Drug Abuse Treatment in Malaysia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00383045 |
Recruitment Status
:
Completed
First Posted
: October 2, 2006
Last Update Posted
: February 24, 2009
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Opiate Dependence | Drug: Buprenorphine/Subutex Drug: Naltrexone Procedure: Drug counseling | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 180 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | HIV Risk Reduction and Drug Abuse Treatment in Malaysia |
Study Start Date : | April 2003 |
Actual Study Completion Date : | August 2007 |

- Time to resumption of heroin use
- Time to relapse
- Maximum consecutive weeks of opiate abstinence
- Reduction of HIV risks
- Addiction-related functional status
- Adverse events

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Opioid dependence
Exclusion Criteria:
- Dependence on alcohol, benzodiazepines or sedatives
- Suicide or homicide risk
- Psychotic disorder or major depression
- Inability to read or understand the protocol or assessment questions
- Life-threatening or unstable medical problems
- Greater than 3 times normal liver enzymes (AST, GGT)

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): NCT00383045
United States, Connecticut | |
Yale University School of Medicine | |
New Haven, Connecticut, United States, 06519 | |
Malaysia | |
Substance Abuse Research Center | |
Muar, Johor, Malaysia |
Principal Investigator: | Richard S. Schottenfeld, M.D. | Yale University | |
Study Director: | Mahmud Mazlan, M.D. | Hospital Muar, Malaysia |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00383045 History of Changes |
Other Study ID Numbers: |
R01DA014718-04 ( U.S. NIH Grant/Contract ) |
First Posted: | October 2, 2006 Key Record Dates |
Last Update Posted: | February 24, 2009 |
Last Verified: | February 2009 |
Keywords provided by Yale University:
Buprenorphine Naltrexone HIV risk reduction behavior Counseling |
Additional relevant MeSH terms:
Substance-Related Disorders Opioid-Related Disorders Chemically-Induced Disorders Mental Disorders Buprenorphine Naltrexone Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists |