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）非常普遍，并推动了马来西亚和该地区其他国家的艾滋病毒流行。在我们最初的随机对照试验中，丁丙诺啡（BUP）在治疗持续时间、连续戒断周数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，因为只有50%的受试者被分配到BUP治疗6个月；只有28%的人避免了再次吸食海洛因；BUP减少了与毒品有关的艾滋病风险行为，但没有减少与性有关的艾滋病风险行为。在马来西亚和美国的实际临床实践中，标准BUP提供相对较少的心理社会服务（简短的医生管理（PM）和每周或更少的服药频率），甚至可能更不有效。因此，我们提出了一项后续研究，以评估标准BUP是否足够，或者一种或两种强化行为治疗的组合-行为药物和艾滋病毒风险降低咨询（BDRC）或禁欲-带回家丁丙诺啡(ACB)-是否提高其疗效并具有成本效益，就提供治疗的直接经济成本而言。BDRC利用短期行为合同促进禁欲和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丁丙诺啡带回家的非偶发药物，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也为戒断提供了积极的激励，并直接观察到那些持续使用海洛因的丁丙诺啡。在拟议的2X2研究中，海洛因依赖患者（N=240）将被诱导使用丁丙诺啡（1-2周），然后随机分配到标准BUP，标准BUP与ACB，标准BUP与BDRC，或标准BUP与两者（3-26周）。主要结果措施包括减少海洛因使用（戒断天数百分比、尿检阿片类药物阴性比例和最长连续戒断周数）以及减少与毒品和性有关的艾滋病毒风险行为。次要结果包括留任率；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。数据分析将重点放在意向处理样本上。研究结果将为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.