Buprenorphine group medical visits for drug users at risk for HIV

 描述(由申请人提供)：在美国，为加强丁丙诺啡初级保健中的丁丙诺啡治疗，阿片成瘾和阿片类药物过量死亡人数迅速增加。通过在初级保健中成功实施丁丙诺啡维持治疗，获得阿片成瘾治疗的机会有所改善；然而，包括阿片类药物戒断在内的治疗结果仍有待优化。我们的首要目标是通过改善初级保健中的BMT结果来减少阿片成瘾的后果，包括艾滋病毒传播。本研究的目的是开发一种基于团体就诊模式的理论指导的行为干预方法，并将其用于初级保健，以加强持续阿片类药物滥用患者的BMT。这项建议旨在：1.)确定基于群体的骨髓移植干预(G-BMT)的关键组成部分，该干预将在初级保健中加强丁丙诺啡治疗结果；2)开展G-BMT干预；初步测试G-BMT在初级保健中的有效性、可接受性和可行性。这些目标将通过对8名骨髓移植提供者和40名骨髓移植患者进行重点小组讨论来实现，使用社会认知理论作为理论框架，以确定患者可以接受并可能导致减少阿片类药物滥用的G-BMT干预的潜在成分。在这项形成性研究的基础上，将制定G-BMT的干预指南，为初级保健中的强化治疗提供新的选择。在一项随机试验中，我们将初步测试G-BMT(在16周内进行8次治疗)的可行性、可接受性和有效性，方法是将G-BMT与常规治疗(TAU)进行比较，这些患者在接受标准办公室BMT的同时，仍在继续滥用阿片类药物。我们假设随机接受G-BMT的参与者将比随机接受TAU的参与者有更高的禁酒率(主要结果，有效性)，更少的艾滋病毒危险行为(有效性)，更高的治疗满意度(可接受性)和更高的访问依从性(可行性)。在这项研究之后，我们将使用可行性和可接受性数据来进一步修改G-BMT干预措施，以及 在一项多点随机试验中，我们将充分检验其在改善禁欲、减少艾滋病毒危险行为和增加持续阿片类药物滥用的骨髓移植患者治疗中的留存率方面的有效性。

 DESCRIPTION (provided by applicant): Group medical visits to intensify buprenorphine treatment in primary care Opioid addiction and opioid overdose deaths have increased rapidly in the United States. Access to opioid addiction treatment has improved through successful implementation of buprenorphine maintenance treatment (BMT) in primary care; however, treatment outcomes, including abstinence from opioids, have yet to be optimized. Our overarching goal is to reduce the consequences of opioid addiction, including HIV transmission, by improving BMT outcomes in primary care. The objective of this study is to develop a manualized theory-guided behavioral intervention based on the model of group medical visits, which will be used in primary care to intensify BMT for patients with ongoing opioid abuse. This proposal aims to: 1.) determine key components of a group-based BMT intervention (G-BMT) that will enhance buprenorphine treatment outcomes within primary care; 2.) develop the G-BMT intervention; and 3.) preliminarily test G-BMT for efficacy, acceptability, and feasibility in primary care. These aims will be achieved by conducting focus groups with eight BMT providers and 40 BMT patients using Social Cognitive Theory as a theoretical framework to determine potential components for the G-BMT intervention that will be acceptable to patients and likely to result in reduced opioid abuse. Based on this formative research, an intervention guide for G-BMT will be developed to provide a novel option for treatment intensification in primary care. In a randomized trial, we will preliminarily test G-BMT (8 sessions over 16 weeks) for feasibility, acceptability, and efficacy, by comparing G-BMT to treatment as usual (TAU) for BMT patients with ongoing opioid abuse while receiving standard office-based BMT. We hypothesize that participants randomized to G- BMT will have higher abstinence rates (primary outcome, efficacy), fewer HIV risk behaviors (efficacy), greater satisfaction with treatment (acceptability) and higher visit adherence (feasibility) than participants randomized to TAU. Following this study, we will use feasibility and acceptability data to further modify the G-BMT intervention, and in a multi-site randomized trial, we will fully examine its effectiveness at improving abstinence, reducing HIV-risk behaviors, and increasing retention in treatment for BMT patients with ongoing opioid abuse.