Drug Counseling and Abstinent-Contingent Take-Home Buprenorphine in Malaysia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00539123
First received: October 2, 2007
Last updated: June 3, 2009
Last verified: June 2009

October 2, 2007
June 3, 2009
September 2007
September 2012   (final data collection date for primary outcome measure)
  • reductions in heroin use [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • reductions in drug- and sex-related HIV risk [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • reductions in heroin use [ Time Frame: 26 weeks ]
  • reductions in drug- and sex-related HIV risk [ Time Frame: 26 weeks ]
Complete list of historical versions of study NCT00539123 on ClinicalTrials.gov Archive Site
  • retention [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • reductions in other illicit drug use [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • changes in functional status [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • retention [ Time Frame: 26 weeks ]
  • reductions in other illicit drug use [ Time Frame: 26 weeks ]
  • changes in functional status [ Time Frame: 26 weeks ]
Not Provided
Not Provided
 
Drug Counseling and Abstinent-Contingent Take-Home Buprenorphine in Malaysia
Drug Counseling and Abstinent-Contingent Take-Home Buprenorphine in Malaysia

A randomized clinical trial evaluating whether Behavioral Drug and HIV Risk Reduction Counseling (BDRC), abstinence-contingent take-home buprenorphine (ACB), or the combination of the two improve efficacy and cost-effectiveness of standard buprenorphine treatment for opiate-dependent individuals in Malaysia.

Heroin and injection drug use (IDU) are highly prevalent and driving the HIV epidemic in Malaysia and other countries in the region. In our original RCT, buprenorphine (BUP) was superior to naltrexone and placebo in treatment retention, weeks of consecutive abstinence and time to heroin use. However, there is room for improvement, since only 50% of subjects assigned to BUP remained in treatment for 6 months; only 28% avoided relapse to heroin; and BUP reduced drug- but not sex-related HIV risk behaviors. In actual clinical practice in Malaysia and the U.S., Standard BUP is provided with relatively minimal psychosocial services (brief physician management (PM) and weekly or less frequent medication pick-up) and may be even less effective. Hence, we propose a follow up study to evaluate whether Standard BUP is sufficient or whether one or a combination of two enhanced behavioral treatments--behavioral drug and HIV risk reduction counseling (BDRC) or abstinence-contingent take-home buprenorphine (ACB)—improve its efficacy and are cost-effective, with regard to the direct economic costs of providing the treatments. 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. ACB, a low cost and feasible alternative to non-contingent take-home buprenorphine, retains many of its advantages--abstinent patients manage their medication supplies outside of the clinic--but ACB also provides positive incentives for abstinence and directly observed buprenorphine for those with continuing heroin use. In the proposed 2X2 study, heroin dependent patients (N=240) will be inducted onto buprenorphine (weeks 1-2) and then randomized to Standard BUP, Standard BUP with ACB, Standard BUP with BDRC, or Standard BUP with both (weeks 3-26). Primary outcome measures include reductions in heroin use (percent days abstinent, proportion of opiate-negative urine tests, and maximum consecutive weeks abstinent) and reductions in drug- and sex-related HIV risk behaviors. Secondary outcomes include retention; reductions in other drug use, hospitalizations, criminal behavior and arrests; and improvements in vocational and family functioning. Data analyses will focus on the intention-to treat sample. The study results will inform practice guidelines and policies regarding buprenorphine treatment.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Opiate Dependence
  • 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
  • Experimental: 1
    Physician Management (PM): medically focused advice and brief counseling
    Intervention: Behavioral: Physician Management (PM)
  • Experimental: 2
    Physician Management (PM) plus Abstinence Contingent Buprenorphine (ACB) dispensing
    Interventions:
    • Behavioral: abstinence-contingent take-home buprenorphine (ACB)
    • Behavioral: Physician Management (PM)
  • Experimental: 3
    PM plus Behavioral Drug and HIV Risk Reduction Counseling (BDRC)
    Interventions:
    • Behavioral: behavioral drug and HIV risk reduction counseling (BDRC)
    • Behavioral: Physician Management (PM)
  • Experimental: 4
    PM plus BDRC plus ACB
    Interventions:
    • Behavioral: behavioral drug and HIV risk reduction counseling (BDRC)
    • Behavioral: abstinence-contingent take-home buprenorphine (ACB)
    • Behavioral: Physician Management (PM)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Mahmud Mazlan, MD 60-6-953-2291 melaun@yahoo.com
United States,   Malaysia
 
NCT00539123
2R01 DA014718-05A1
Yes
Richard S. Schottenfeld, MD, Yale University School of Medicine
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Richard S. Schottenfeld, MD Yale University
Study Director: Mahmud Mazlan, MD Substance Abuse Research Center, Muar
Yale University
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP