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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00539123 |
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Date of registration:
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02/10/2007 |
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Primary sponsor: |
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Public title:
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Drug Counseling and Abstinent-Contingent Take-Home Buprenorphine in Malaysia
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Scientific title:
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Drug Counseling and Abstinent-Contingent Take-Home Buprenorphine in Malaysia |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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240 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00539123 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Malaysia
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United States
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Contacts
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Name:
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Mahmud Mazlan, MD |
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Address:
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Telephone:
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60-6-953-2291 |
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Email:
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melaun@yahoo.com |
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Affiliation:
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Name:
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Mahmud Mazlan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Substance Abuse Research Center, Muar |
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Name:
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Richard S. Schottenfeld, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Yale University |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Opiate Dependence
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Intervention(s)
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Behavioral: abstinence-contingent take-home buprenorphine (ACB)
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Behavioral: behavioral drug and HIV risk reduction counseling (BDRC)
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Behavioral: Physician Management (PM)
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Primary Outcome(s)
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reductions in drug- and sex-related HIV risk
[Time Frame: 26 weeks]
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reductions in heroin use
[Time Frame: 26 weeks]
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Secondary Outcome(s)
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changes in functional status
[Time Frame: 26 weeks]
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reductions in other illicit drug use
[Time Frame: 26 weeks]
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retention
[Time Frame: 26 weeks]
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Secondary ID(s)
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2R01 DA014718-05A1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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