Drug Counseling and Abstinent-Contingent Take-Home Buprenorphine in Malaysia
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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 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
      buprenorphine and counseling remained in treatment for 6 months; only 28% avoided relapse to
      heroin; and treatment reduced drug- but not sex-related HIV risk behaviors. In actual
      clinical practice in Malaysia and the U.S. buprenorphine treatment effectiveness may be even
      less, because buprenorphine is provided with relatively minimal psychosocial services (often
      brief physician management (PM) alone, without additional counseling), and without additional
      behavioral interventions or contingency management. Hence, we propose a follow up study to
      evaluate whether standard buprenorphine treatment (consisting of buprenorphine provision, PM,
      and non-contingent provision of take-home doses of buprenorphine, NCB) is sufficient or
      whether one or a combination of two behavioral treatments--behavioral drug and HIV risk
      reduction counseling (BDRC) or abstinence-contingent take-home buprenorphine (ACB)-improve
      its efficacy. 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 (NCB), 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 PM with NCB, PM with ACB, PM
      with BDRC and NCB, or PM with BDRC and ACB (weeks 3-26). Primary outcome measures include
      reductions in heroin use (percent days abstinent, proportion of opiate-negative urine tests)
      and reductions in drug- and sex-related HIV risk behaviors. Data analyses will focus on the
      intention-to treat sample. The study results will inform practice guidelines and policies
      regarding buprenorphine treatment.
    

Intervention name(s): behavioral drug and HIV risk reduction counseling (BDRC); abstinence-contingent buprenorphine (ACB)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; Participants achieving heroin abstinence documented by an opioid-negative urine test receive take-home doses of buprenorphine-naloxone, with the number of take-home doses permitted increasing depending on the number of consecutive opioid-negative urine tests. Participants who test positive receive all doses of buprenorphine-naloxone under direct observation in the clinic, using a three-times per week dosing protocol.
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: 2x2 factorial design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: buprenorphine; drug counseling; HIV risk reduction counseling