Drug Counseling and Abstinent-Contingent Take Home Buprenorphine in Malaysia

描述(申请人提供)：海洛因和注射毒品使用(IDU)非常普遍，并在马来西亚和该地区其他国家推动艾滋病毒流行。在我们最初的随机对照试验中，丁丙诺啡(BUP)在治疗保留、连续戒断数周和海洛因使用时间方面优于纳曲酮和安慰剂。然而，还有改进的空间，因为分配到BUP组的受试者中只有50%的人继续接受治疗6个月；只有28%的人避免了海洛因的复发；BUP减少了与毒品有关的艾滋病毒危险行为，但没有减少与性有关的艾滋病毒危险行为。在马来西亚和美国的实际临床实践中，Standard BUP只提供相对最低限度的心理社会服务(简要的医生管理(PM)和每周或更少频繁的取药)，可能效果更差。因此，我们建议进行一项后续研究，以评估标准BUP是否足够，或者就提供治疗的直接经济成本而言，是否一种或两种增强型行为治疗--行为药物和HIV风险降低咨询(BDRC)或戒断条件下带回家的丁丙诺啡(ACB)--提高了其疗效和成本效益。BDRC利用短期行为合同促进禁欲，减少与药物和性相关的艾滋病毒危险行为，并可由马来西亚医疗机构提供的护士和医疗助理提供。ACB是一种低成本和可行的非偶然带回家丁丙诺啡的替代品，保留了它的许多优点-戒断患者在诊所外管理他们的药物供应-但ACB也提供了积极的戒断动机，并为那些继续使用海洛因的人提供了直接观察丁丙诺啡。在拟议的2X2研究中，海洛因依赖者(N=240)将被诱导使用丁丙诺啡(第1-2周)，然后随机分为标准BUP、标准BUP+ACB、标准BUP+BDRC、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(戒除天数百分比、阿片类药物尿检阴性的比例、最长连续几周的戒毒)以及与药物和性相关的艾滋病毒危险行为的减少。次要结果包括留存；其他药物使用、住院、犯罪行为和逮捕的减少；以及职业和家庭功能的改善。数据分析将重点放在意向上--处理样本。研究结果将为丁丙诺啡治疗的实践指南和政策提供参考。

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.