Interim Buprenorphine Treatment to bridge waitlist delays: Stage II evaluation

项目摘要 尽管阿片类药物维持治疗有效，过量（OD）死亡人数惊人增加， 持续治疗。在这些治疗延迟期间，阿片类药物滥用者面临非法药物使用的风险，犯罪 活动、传染病、OD和过早死亡。行为和综合治疗发展 R34，我们已经开发了一种临时丁丙诺啡治疗（IBT）的等待阿片类药物滥用者， 包括四个关键组成部分：通过安全的计算机化设备分发丁丙诺啡; 交互式语音应答（IVR）电话系统，评估药物使用、戒断和渴望; IVR生成 随机回访;通过iPad提供艾滋病毒+肝炎教育。我们的第一阶段数据强烈支持最初的 IBT的疗效，第4、8和12周时分别有87%、87%和75%的IBT参与者戒烟，而第4、8和12周时分别有0%、0%和0%的IBT参与者戒烟 等待名单对照组（WLC）参与者的平均体重（p<.0001）。IBT参与者还报告IV减少更多 药物使用频率（p<0.001）和完成95%的日常IVR呼叫和随机回叫。 与R34机制一致，我们的初步研究涉及有限的样本量（n=48）和单个 学术研究诊所重要的是要评估这些极其有希望的结果是否被复制 当在更大规模上实施时。主要目的：在这项II期随机试验中，我们评价IBT的疗效 在200名等待名单上的阿片类药物依赖成年人中。UVM将作为协调中心和主要招聘 我们将招募100名参与者。我们将与两个农村地区的联邦合格卫生中心合作， 佛蒙特州各县每个研究中心招募50名参与者。IBT参与者将接受上述干预; WLC 参加者将留在候补名单上，但完成同样的4周、8周和12周评估。我们假设 IBT参与者相对于WLC参与者将实现显著更大的非法阿片类药物戒断。 次要目的：（1）虽然我们的试点研究表明，除了禁欲本身，IBT还有一些相关的益处， 没有足够的把握度来检查除禁欲以外的IBT效应。这次审判将使我们能够彻底 研究IBT在社会心理功能重要领域的更广泛影响。(2)R34的数据显示 关于阿片类药物过量预防的教育是这些患者迫切需要的领域。创新和 评价吸毒过量预防教育。(3)虽然有利的成本效益结果已被证明， 传统的美沙酮和丁丙诺啡治疗，没有研究调查IBT的成本效益。 我们将进行经济分析，为供应商采用IBT的决策提供信息。 该项目直接建立在我们第一阶段研究的有希望的结果上，并准备减少 与阿片类药物治疗延迟相关的巨大经济和社会成本。通过促进消除 候补名单，这个项目代表了一个显着偏离现状，并站在产生一个 阿片类药物依赖治疗的概念化和实施方式发生了根本性转变。

PROJECT SUMMARY Despite the efficacy of opioid maintenance and alarming increases in overdose (OD) deaths, waiting lists for treatment persist. During these treatment delays opioid abusers are at risk for illicit drug use, criminal activity, infectious disease, OD and premature death. With a Behavioral & Integrative Treatment Development R34, we have developed an Interim Buprenorphine Treatment (IBT) for waitlisted opioid abusers that includes four key components: Buprenorphine dispensed via secure computerized device; nightly calls from an Interactive Voice Response (IVR) phone system assessing drug use, withdrawal and craving; IVR-generated random call-backs; HIV+Hepatitis Education delivered via iPad. Our Stage I data strongly support the initial efficacy of IBT, with 87%, 87% and 75% of IBT participants abstinent at Weeks 4, 8 and 12 vs. 0%, 0% and 0% of Waitlist Control (WLC) participants (p<.0001). IBT participants are also reporting greater reductions in IV drug use frequency (p<.001) and completing 95% of daily IVR calls and random call-backs. Consistent with the R34 mechanism, our pilot study involved a limited sample size (n=48) and a single academic research clinic. It is important to evaluate whether these extremely promising results are replicated when implemented on a larger scale. Primary Aim: In this Stage II randomized trial, we evaluate IBT efficacy in 200 waitlisted opioid-dependent adults. UVM will serve as the coordinating center and primary recruitment site where we will enroll 100 participants. We will partner with federally qualified health centers in two rural Vermont counties to enroll 50 participants per site. IBT participants will receive the intervention above; WLC participants will remain on waitlists but complete the same 4-, 8- and 12-week assessments. We hypothesize that IBT participants will achieve significantly greater illicit opioid abstinence relative to WLC participants. Secondary Aims: (1) While our pilot study suggests some IBT-related benefits beyond abstinence per se, it was insufficiently powered to examine IBT effects other than abstinence. This trial will permit us to thoroughly examine IBT's broader impacts in important areas of psychosocial functioning. (2) Data from our R34 indicate that education around opioid OD prevention is an area of critical need for these patients. We will develop and evaluate an OD prevention education. (3) While favorable cost-benefit outcomes have been demonstrated for conventional methadone and buprenorphine treatment, no study has investigated the cost effectiveness of IBT. We will conduct economic analyses that will inform providers' decisions around IBT adoption. This project builds directly on the promising results from our Stage I research and is poised to reduce the vast economic and societal costs associated with opioid treatment delays. By facilitating the eradication of waitlists, this project represents a significant departure from the status quo and stands to produce a fundamental shift in how treatment of opioid dependence is conceptualized and delivered.