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

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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.