Drug Counseling and Abstinent-Contingent Take Home Buprenorphine in Malaysia

描述（由申请人提供）：海洛因和注射毒品使用（IDU）在马来西亚和该地区其他国家非常普遍，并推动了艾滋病毒的流行。在我们最初的RCT中，丁丙诺啡（BUP）在治疗保留、连续戒断周数和海洛因使用时间方面上级纳洛酮和安慰剂。然而，还有改进的余地，因为只有50%的被分配到BUP的受试者保持治疗6个月;只有28%的人避免了海洛因复发; BUP减少了与药物有关的HIV风险行为，但没有减少性相关的HIV风险行为。在马来西亚和美国的实际临床实践中，标准BUP提供相对最少的心理社会服务（简短的医生管理（PM）和每周或更少频率的药物提取），并且可能更不有效。因此，我们提出了一个后续研究，以评估是否标准BUP是足够的，或者是否一个或两个增强的行为治疗-行为药物和艾滋病毒风险降低咨询（BDRC）或禁欲-特遣队带回家丁丙诺啡（ACB）的组合-提高其疗效和成本效益，关于提供治疗的直接经济成本。BDRC利用短期行为合同促进禁欲，减少与毒品和性有关的艾滋病毒风险行为，可由马来西亚医疗机构的护士和医疗助理提供。ACB是一种低成本和可行的替代非应急带回家丁丙诺啡，保留了许多药物-禁欲患者在诊所外管理他们的药物供应-但ACB也为禁欲提供了积极的激励措施，并为那些持续使用海洛因的人直接观察丁丙诺啡。在拟定的2X2研究中，海洛因依赖患者（N=240）将接受丁丙诺啡诱导治疗（第1-2周），然后随机分配至标准BUP、标准BUP + ACB、标准BUP + BDRC或标准BUP+两者（第3-26周）。主要结果指标包括海洛因使用的减少（戒断天数百分比，阿片类药物阴性尿检比例和最大连续戒断周数）以及药物和性相关HIV风险行为的减少。次要结果包括保留;减少其他药物使用，住院，犯罪行为和逮捕;以及职业和家庭功能的改善。数据分析将侧重于意向治疗样本。研究结果将为有关丁丙诺啡治疗的实践指南和政策提供信息。

DESCRIPTION (provided by applicant): 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.