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.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
3R01DA014718-09S1
Application #
8572732
Study Section
Behavioral and Social Consequences of HIV/AIDS Study Section (BSCH)
Program Officer
Aklin, Will
Project Start
2001-09-30
Project End
2014-08-31
Budget Start
2012-11-01
Budget End
2014-08-31
Support Year
9
Fiscal Year
2013
Total Cost
$90,312
Indirect Cost
$13,905
Name
Yale University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520
Ruger, Jennifer Prah; Chawarski, Marek; Mazlan, Mahmud et al. (2012) Costs of addressing heroin addiction in Malaysia and 32 comparable countries worldwide. Health Serv Res 47:865-87
Chawarski, M C; Zhou, W; Schottenfeld, R S (2011) Behavioral drug and HIV risk reduction counseling (BDRC) in MMT programs in Wuhan, China: a pilot randomized clinical trial. Drug Alcohol Depend 115:237-9
Schottenfeld, Richard S; Chawarski, Marek C; Mazlan, Mahmud (2008) Maintenance treatment with buprenorphine and naltrexone for heroin dependence in Malaysia: a randomised, double-blind, placebo-controlled trial. Lancet 371:2192-200
Mazlan, Mahmud; Schottenfeld, Richard S; Chawarski, Marek C (2006) New challenges and opportunities in managing substance abuse in Malaysia. Drug Alcohol Rev 25:473-8
Chawarski, Marek C; Mazlan, Mahmud; Schottenfeld, Richard S (2006) Heroin dependence and HIV infection in Malaysia. Drug Alcohol Depend 82 Suppl 1:S39-42