Drug Counseling and Abstinent-Contingent Take-Home Buprenorphine 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.

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