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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.

慢性疼痛患者通常接受长期阿片类药物治疗（LTOT），尽管有阿片类药物的风险。相关危害包括疼痛敏感性增加、阿片类药物滥用、过量和阿片类药物使用障碍（OUD）。对于某些患者，LTOT的风险可能超过其获益。例如，大约25%的人接受LTOT治疗疼痛参与阿片类药物滥用行为，如未经授权的剂量递增或使用阿片类药物来缓解负面情绪因为阿片类药物滥用会带来一系列其他阿片类药物相关的风险，显示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方法来降低这些风险。以患者为中心的阿片类药物逐渐减少可能是由连续性行为促进的。干预措施。然而，由于致病机制的复杂性，阿片类药物滥用和OUD的慢性疼痛，很少有干预措施被证明是有效的促进阿片类药物逐渐减少并安全地减少LTOT患者中阿片类药物相关的危害。现有的治疗方法可能有限的功效，因为它们不能直接修复大脑奖励系统的失调，行为升级的恶性循环为了解决这一差距，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阿片类药物滥用和慢性疼痛的创新治疗，称为以正念为导向的恢复增强（更多），旨在增强奖励过程的认知调节。在多个随机对照接受MORE治疗的患者减少了阿片类药物剂量和阿片类药物相关危害，改善慢性疼痛和生活质量。阿片类药物剂量减少是患者主动的，没有医生的明确指导。MORE尚未与显式以患者为中心的阿片类药物减量方案。鉴于其作为独立干预措施的有效性，我们假设在以患者为中心的阿片类药物减量中增加更多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。在新泽西的10个初级保健诊所，犹他州，我们建议进行一项MORE的混合2实施-有效性RCT，经济上可持续的、保险可报销的团体医疗访问（我们的主要实施战略），辅助以患者为中心的阿片类药物减量方案，该方案利用患者代理和治疗期待鉴于新泽西和犹他州之间存在显著的人口差异，本研究将最大限度地地理和种族/民族多样性，并提供高度的普遍性的调查结果。患者告知，根据我们的经验，我们的试验设计将确定MORE+以患者为中心的阿片类药物减量是否社区提供者可以有效和忠实地实施干预，并将评估实施要素和干预成本效益，影响其在社区的吸收。