Effect of Mindfulness Training on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment

阿片类药物使用障碍(OUD)是一个国家健康危机。办公室阿片类药物治疗(OBOT) 丁丙诺啡/纳洛酮(B/N)可防止过量死亡。心理社会压力与精神病学 问题(如焦虑)是OBOT辍学和复发的主要原因。许多患者求助于 苯二氮类药物(BZD)，用于缓解焦虑和情绪困扰，并产生危险的后果。 治疗焦虑、压力和情绪失调的非药物方法是必要的 初级保健OBOT，这是美国大多数县OUD治疗的主要接入点。 基于正念的干预(MBI)安全可靠地减少压力、焦虑、 抑郁和慢性疼痛，这可能会增加OBOT滞留，同时降低复发率 以及服药过量死亡。然而，目前8周的标准mbi似乎没有很强的， 对药物使用结果的持续影响，表明在以下方面需要更长或更强的mbi OUD处理设置。该项目最初提出的目的是调整、改进和比较 为期6个月的在线实时正念康复和连续护理(M-ROCC)与 初级保健标准康复组。M-ROCC是从循证的、既定的 初级护理正念训练(MTPC)计划，已适应阿片类药物的使用 无序。M-ROCC包括灵活的、以患者为中心、激励响应的设计，包括 低剂量正念入门小组、正念维持签到支持小组和 初级护理强化正念训练(MTPC-OUD)组。M-ROCC建立在 之前展示的提升正念练习剂量阶梯方法，这有助于 有意识的人培养动机并解决正念练习的矛盾心理。MTPC拥有 被证明可以降低焦虑、压力和抑郁，同时提高自我效能感和 通过使用自我调节机制来改变行为。在R21阶段，我们建立了 M-ROCC计划的可行性和可接受性，并通过培训为R33阶段做准备 供应商，并获得必要的批准和现场合同。在R33阶段，我们计划 进行一项五点随机对照试验，比较M-ROCC与基于组的阿片类药物治疗(GBOT)。由于 在新冠肺炎大流行期间，我们修改了R33阶段的所有方面，以与国家 以远程、实时在线虚拟格式提供的示例，比较了M-ROCC和标准在线恢复 196名患者为OUD开B/N，主要评估其对阿片类药物使用的影响和 焦虑。我们都评估对可卡因和BZD使用的影响，以及所需的自我调节方面 以便持续戒除毒瘾。在线临床试验的参与者是从多个美国 通过供应商外联和社交媒体广告向各州提供服务。

Opioid Use Disorder (OUD) is a national health crisis. Office-Based Opioid Treatment (OBOT) with buprenorphine/naloxone (B/N) prevents overdose deaths. Psychosocial stress and psychiatric problems (e.g., Anxiety) are major reasons for OBOT drop out and relapse. Many patients turn to benzodiazepines (BZD) to address anxiety and emotional distress with dangerous consequences. Nonpharmacologic approaches to anxiety, stress, and emotion dysregulation are needed during primary care OBOT, which is the primary access point for OUD treatment in most US counties. Mindfulness-Based Interventions (MBI) safely and reliably reduce the impact of stress, anxiety, depression, and chronic pain, which could increase OBOT retention, while reducing rates of relapse and overdose deaths. However, current 8-week standard MBIs do not appear to have strong, sustained impact on substance use outcomes, suggesting longer or enhanced MBIs are needed in the OUD treatment setting. This project originally proposed to adapt, refine, and compare the effectiveness of the 6-month live-online Mindful Recovery OUD Care Continuum (M-ROCC) versus a standard recovery group in primary care. M-ROCC is derived from the evidence-based, established Mindfulness Training for Primary Care (MTPC) program, which has been adapted for Opioid Use Disorder. M-ROCC includes a flexible, patient-centered, motivationally responsive design, including a Low Dose Mindfulness Entry Group, Mindfulness Maintenance Check-in Support Group, and an intensive Mindfulness Training for Primary Care (MTPC-OUD) Group. M-ROCC builds on the previously demonstrated ascending mindfulness practice dose ladder approach, which helps individuals with OUD nurture motivation and resolve ambivalence for mindfulness practice. MTPC has been shown to lower anxiety, stress, and depression, while increasing self-efficacy and capacity for behavioral change by engaging self-regulation mechanisms. During the R21 phase, we established the feasibility and acceptability of the M-ROCC program and prepared for the R33 phase by training providers and obtaining necessary approvals and site contracts. In the R33 phase, we planned to conduct a five-site RCT comparing M-ROCC versus Group-Based Opioid Treatment (GBOT). Due to the COVID-19 pandemic, we modified all aspects of the R33 phase to be conducted with a national sample in a remote, live-online, virtual format, comparing M-ROCC versus a standard online recovery group for 196 patients prescribed B/N for OUD, primarily evaluating its impact on opioid use and anxiety. We all evaluate effects on cocaine and BZD use, as well as aspects of self-regulation needed for sustained addiction recovery. Participants in the online clinical trial are recruited from multiple U.S. states through provider outreach and social media advertising.