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

通过以正念为导向的恢复增强来优化以患者为中心的阿片类药物逐渐减少

基本信息

批准号：
10715903
负责人：
Nina Cooperman
金额：
$ 341.45万
依托单位：
UNIVERSITY OF UTAH
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-08-15 至 2026-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10715903
关键词：
Address Adoption Automobile Driving Back Behavior Behavior Therapy Behavioral Brain Communities Cost Analysis Data Dose Effectiveness Electronics Elements Emotions Expectancy Funding Geography Goals Hybrids Individual Insurance Integrative Therapy Internal Medicine Intervention Life Link Maintenance Measures Medical Medical Care Costs Mental Health Morbidity - disease rate National Institute of Drug Abuse New Jersey Opioid Overdose Pain management Pathogenicity Patient Agents Patient Care Patients Persons Physicians Population Primary Care Process Protocols documentation Provider Publishing Quality of life Quality-Adjusted Life Years Race Randomized, Controlled Trials Reach, Effectiveness, Adoption, Implementation, and Maintenance Recommendation Recovery Reporting Research Design Research Methodology Rewards Risk Risk Reduction Science Series Suicide Symptoms System Testing Therapeutic Training Translating United States Utah Visit affective neuroscience biobehavior chronic pain chronic pain patient cognitive control cognitive enhancement cognitive reappraisal community clinic cost effectiveness cost-effectiveness evaluation cost-effectiveness ratio craving cue reactivity design drug reward effectiveness testing effectiveness-implementation RCT efficacy testing emotional distress ethnic diversity experience experimental study flexibility follow-up implementation evaluation implementation strategy improved improved outcome incremental cost-effectiveness indexing innovation intervention cost mindfulness mortality neurophysiology novel therapeutic intervention opioid misuse opioid tapering opioid therapy opioid use opioid use disorder overdose risk pain sensitivity patient oriented primary care clinic primary outcome programs remediation research and development response reward processing secondary outcome skills standard care therapy development tool trial design uptake

项目摘要

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.

尽管阿片类药物存在风险，但慢性疼痛患者通常接受长期阿片类药物治疗 (LTOT) 治疗相关危害包括疼痛敏感性增加、阿片类药物滥用、用药过量和阿片类药物使用障碍 (OUD)。对于某些患者来说，LTOT 的风险可能超过其益处。例如，大约 25% 的人因疼痛而接受 LTOT 从事阿片类药物滥用行为，例如未经授权的剂量递增或使用阿片类药物阿片类药物可以缓解负面情绪。因为阿片类药物滥用会带来一系列其他与阿片类药物相关的风险危害，出现阿片类药物滥用迹象的患者需要安全、灵活、以患者为中心的阿片类药物逐渐减少方法以减少这些风险。辅助行为可能有助于以患者为中心的阿片类药物逐渐减少干预措施。然而，由于致病机制的复杂性，加剧了疾病的螺旋式下降。由于阿片类药物滥用和 OUD 导致慢性疼痛，很少有干预措施被证明能有效促进阿片类药物逐渐减少并安全减少 LTOT 患者与阿片类药物相关的危害。现有疗法可能有功效有限，因为它们无法直接纠正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 资助的综合行为在治疗开发过程中，我们将情感神经科学的机制发现转化为针对阿片类药物滥用和慢性疼痛的创新疗法，称为“正念导向恢复增强” （更多），旨在增强奖励过程的认知调节。在多个随机对照试验（RCT）接受更多阿片类药物治疗的患者减少阿片类药物剂量和阿片类药物相关危害，同时证明改善慢性疼痛和生活质量。这种阿片类药物剂量减少是由患者发起并发生的没有医生的明确指导。 MORE 尚未与显式结合进行测试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所表现出的功效，我们假设增加以患者为中心的阿片类药物逐渐减少将大大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。新泽西州的十家初级保健诊所和犹他州，我们建议开展一项 MORE 的混合 2 实施效果随机对照试验，通过经济上可持续的、保险可报销的团体医疗就诊（我们的关键实施策略）作为辅助以患者为中心的阿片类药物逐渐减少方案，利用患者的自主性和治疗效果期望。鉴于新泽西州和犹他州之间存在显着的人口差异，这项研究将最大化地理和种族/族裔多样性，并提供研究结果的高度普遍性。经患者告知根据生活经验，我们的试验设计将决定 MORE 加上以患者为中心的阿片类药物是否逐渐减少社区提供者可以有效和忠实地实施干预，并将评估影响社区接受程度的实施要素和干预成本效益。