Optimizing Patient-Centered Opioid Tapering with Mindfulness-Oriented Recovery Enhancement

慢性疼痛的患者通常接受长期阿片类药物治疗(LTOT)，尽管存在阿片类药物的风险- 相关危害包括疼痛敏感度增加、阿片类药物滥用、过量和阿片类药物使用障碍(OUD)。 对于一些患者来说，LTOT的风险可能超过它的好处。例如，大约25%的人 接受LTOT止痛，有阿片类药物滥用行为，如未经授权增加剂量或使用 阿片类药物可以缓解负面情绪。因为阿片类药物的滥用增加了其他一系列与阿片类药物相关的风险 危害，阿片类药物滥用迹象的患者需要安全、灵活的以患者为中心的阿片类药物逐渐减少的方法 来降低这些风险。辅助行为可促进以患者为中心的阿片类药物的逐渐减少 干预措施。然而，由于推动螺旋式下降的致病机制的复杂性， 慢性疼痛到阿片类药物的滥用，很少有干预措施被证明在促进 阿片类药物的逐渐减少和安全地减少与阿片类药物有关的危害。现有的治疗方法可能会 疗效有限，因为它们不能直接补救支撑这一点的大脑奖励系统的失调 行为升级的螺旋式下降。为了解决这一差距，通过NIDA资助的综合行为 治疗开发过程中，我们将情感神经科学中的机械发现转化为 阿片类药物滥用和慢性疼痛的创新治疗，称为正念导向恢复促进 (更多)，旨在加强对奖励过程的认知调节。在多重随机对照中 试验(RCT)患者接受更少的阿片类药物剂量和阿片类药物相关损害的治疗，同时有证据 改善慢性疼痛和生活质量。这种阿片类药物剂量的减少是由患者发起并发生的 如果没有医生的明确指导。更多内容尚未与显式 以患者为中心的阿片类药物逐渐减少方案。鉴于其作为独立干预措施已证明的有效性，我们 假设增加更多以患者为中心的阿片类药物缩减将有力地减少阿片类药物相关的危害 同时改善慢性疼痛和生活质量。在新泽西州的十家初级保健诊所和 犹他州我们建议实施混合2实施-有效性RCT，通过 经济上可持续的、保险可报销的团体医疗访问(我们的关键实施战略) 对以患者为中心的阿片类药物逐渐减少方案的补充，该方案利用患者机构和治疗 期望值。鉴于新泽西州和犹他州之间的显著人口差异，这项研究将最大限度地 地理和种族/民族的多样性，并提供了高度的结论的概括性。由以下患者告知 生活经验，我们的试验设计将决定是否更多地以患者为中心的阿片类药物逐渐减少 社区提供者可以有效和准确地实施干预措施，并将评估 影响其在社区中普及的实施要素和干预成本效益。

Patients with chronic pain are commonly treated with long-term opioid therapy (LTOT) despite risk of opioid- related harms including increased pain sensitivity, opioid misuse, overdose, and opioid use disorder (OUD). The risks of LTOT may outweigh its benefit for some patients. For instance, approximately 25% of individuals receiving LTOT for pain engage in opioid misusing behaviors such as unauthorized dose escalation or using opioids to alleviate negative emotions. Because opioid misuse confers risks for a range of other opioid-related harms, patients showing signs of opioid misuse need safe, flexible patient-centered opioid tapering approaches to reduce these risks. Patient-centered opioid tapering may be facilitated by adjunctive behavioral interventions. However, due to the complexity of the pathogenic mechanisms fueling the downward spiral from chronic pain to opioid misuse and OUD, few interventions have been shown to be efficacious in facilitating opioid tapering and safely reducing opioid-related harms among people with LTOT. Extant therapies may have limited efficacy because they fail to directly remediate dysregulation of brain reward systems underpinning this downward spiral of behavioral escalation. To address this gap, through a NIDA-funded integrative behavioral treatment development process we translated mechanistic findings from affective neuroscience into an innovative treatment for opioid misuse and chronic pain, called Mindfulness-Oriented Recovery Enhancement (MORE), that aims to enhance cognitive regulation of reward processes. In multiple randomized controlled trials (RCTs) patients treated with MORE reduced opioid dosing and opioid-related harms while evidencing improvements in chronic pain and quality of life. This opioid dose reduction was patient-initiated and occurred without explicit guidance from a physician. MORE has not yet been tested in combination with an explicit patient-centered opioid tapering protocol. Given its demonstrated efficacy as a standalone intervention, we hypothesize that adding MORE to patient-centered opioid tapering will robustly reduce opioid-related harms while simultaneously improving chronic pain and quality of life. In ten primary care clinics in New Jersey and Utah we propose to conduct a hybrid 2 implementation-effectiveness RCT of MORE as delivered via an economically sustainable, insurance-reimbursable group medical visit (our key implementation strategy) as an adjunct to a patient-centered opioid tapering protocol that leverages patient agency and therapeutic expectancy. Given significant population differences between New Jersey and Utah, this study will maximize geographic and racial/ethnic diversity and provide high generalizability of findings. Informed by patients with lived experience, our trial design will determine whether the MORE plus patient-centered opioid tapering intervention can be implemented with effectiveness and fidelity by community providers, and will evaluate the implementation elements and intervention cost effectiveness that influence its uptake in the community.