Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use and Chronic Pain Management

项目总结 美国正在经历阿片类药物的使用和过量危机。为了应对这一流行病，全国各地正在实施一系列治疗阿片类药物使用障碍的战略，新泽西州正在扩大和加强药物辅助治疗(MAT)服务，对阿片类药物危机补助金做出有针对性的国家反应。MAT是对阿片使用障碍(OUD)最有效的干预措施，美沙酮维持治疗(MMT)是最常用的处方MAT；然而，大约一半开始MMT的人在一年内停止使用，一半留在MMT的人在六个月内复发。慢性疼痛影响着服用MMT的大多数人，可能会导致这一群体的复发。 需要新的行为干预措施，解决服用垫子的人的慢性疼痛和阿片类药物复发。尽管几种行为疗法在单独治疗疼痛和阿片类药物使用方面显示出有效性，但很少有干预措施同时解决这些共同发生的问题。然而，面向正念的恢复增强(MORE)是最近开发的，用于治疗疼痛和阿片类药物滥用。更多的是一种团体干预，结合正念、认知重新评估和积极情绪调节技能的训练，针对导致阿片类药物复发的功能障碍的认知、情感和行为途径。此外，MORE的早期试验证明了其在减少疼痛严重程度、疼痛相关功能障碍、阿片类药物渴望和阿片类药物滥用的主观评估方面的有效性。然而，到目前为止，这一有希望的干预措施从未被测试为预防复发和解决卧床不起患者慢性疼痛的辅助治疗。 这项建议的目的是检查更多对接受MMT的患者中阿片类药物复发和慢性疼痛的影响。我们的中心假设是，MMT的有效性将通过辅助行为治疗来增强，帮助患者应对可能导致阿片类药物复发的慢性疼痛、压力和情绪失调。我们将首先进行一项小规模的初步研究，以测试我们研究方法的可行性(R21；N=30)。然后我们将进行一项更大的研究(R33；N=150，估计)，以评估关于一系列临床结果的更多信息。这两项研究都将涉及一项双臂、个人随机对照试验设计，该设计与MMT如常(TAU)进行了更多的比较。 对于R21，我们的目标是试行研究协议，以确定可行性。本研究阶段将侧重于确定招募、留住和跟踪研究参与者的研究可行性。通过R33，我们的目标是1)确定与TAU相关的更多疗效，2)探索阿片类药物使用结果的中介因素。如果这项研究成功，它可以确定一种有希望的干预措施，帮助服用MMT的人应对与慢性疼痛相关的压力和功能障碍，降低他们再次使用阿片类药物的风险，并提高他们的整体生活质量。

PROJECT SUMMARY The United States is experiencing an opioid use and overdose crisis. To address the epidemic, a wide range of strategies to treat opioid use disorders are being implemented across the country, and New Jersey is expanding and enhancing medication assisted treatment (MAT) services with a State Targeted Response to the Opioid Crisis Grant. MAT is the most effective intervention for an opioid use disorder (OUD), and methadone maintenance treatment (MMT) is the most commonly prescribed MAT; however, approximately half of people who begin MMT discontinue within a year, and half of people retained in MMT have an opioid relapse within six months. Chronic pain, affecting most people on MMT, could be contributing to relapse in this group. Novel behavioral interventions that address both chronic pain and opioid relapse among people on MAT are needed. Although several behavioral therapies have shown efficacy in separately treating pain and opioid use, few interventions exist which address these co-occurring problems simultaneously. However, Mindfulness Oriented Recovery Enhancement (MORE) was recently developed to treat both pain and opioid misuse. MORE is a group intervention that combines training in mindfulness, cognitive reappraisal, and positive emotion regulation skills to target the dysfunctional cognitive, affective, and behavioral pathways that lead to opioid use relapse. Moreover, an early stage trial of MORE has demonstrated its efficacy in reducing subjective assessments of pain severity, pain related dysfunction, opioid craving, and opioid misuse. However, to date, this promising intervention has never been tested as an adjunctive therapy to prevent relapse and address chronic pain among people with an OUD on MAT. The objective of this proposal is to examine the impact of MORE on opioid relapse and chronic pain among individuals receiving MMT. Our central hypothesis is that MMT effectiveness will be enhanced by an adjunctive behavioral treatment that helps patients cope with the chronic pain, stress, and emotion dysregulation that could lead to opioid relapse. We will first conduct a small pilot study to test the feasibility of our study methods (R21; N=30). We will then conduct a larger study (R33; N=150, estimated) to assess MORE with respect to a range of clinical outcomes. Both studies will involve a 2-arm, individually randomized controlled trial design that compares MORE to MMT as usual (TAU). With the R21, we aim to pilot study protocol to determine feasibility. This study phase will focus on establishing study feasibility in recruiting, retaining, and following up study participants. With the R33, we aim to 1) determine MORE efficacy relative to TAU and 2) explore mediators of opioid use outcomes. If this study is successful, it could identify a promising intervention for helping people on MMT to cope with the stress and dysfunction associated with chronic pain, reduce their risk of opioid use relapse, and enhance their overall quality of life.