ABSTRACT Nearly half a million Americans receive buprenorphine for opioid use disorder (OUD). More than 40% of those seeking treatment with buprenorphine have pain that interferes with daily activities and affects drug treatment outcomes, yet no effective non-pharmacological therapies exist to improve pain outcomes. Developing a novel pain treatment is complicated by the fact that among opioid dependent patients, pain often co-occurs with depression. We developed a collaborative primary care approach, entitled TOPPS (Treating Opioid Patients’ Pain and Sadness), in which behavioral health specialists and primary care providers share a unified plan for addressing pain and depression in patients receiving buprenorphine. The newly developed intervention integrates and builds upon behavior therapy for chronic pain and depression with the aim of reducing behavioral avoidance and increasing behavioral activation. In our pilot work, we demonstrated that TOPPS meets standards of feasibility and preliminary efficacy and, building on our R34 findings, we now propose a randomized controlled trial of TOPPS compared to a health education contact-control condition among 250 persons with OUD recruited from two primary care-based buprenorphine programs. We will provide both interventions over three months and follow participants for a total of 12 months in order to observe both short- term and longer-term effects of TOPPS. P ain-related interference with physical and psychosocial functioning (“pain interference”), pain severity and depression will be the primary outcome variables assessed, and buprenorphine treatment retention will be the secondary outcome variable. Our goal is for this research to result in the incorporation into buprenorphine care of theoretically-driven, empirically-tested therapy for patients with pain and depressive symptoms. We believe that TOPPS will lead to improved pain, depression, and substance use outcomes, and can utilize providers available within buprenorphine programs, broadening the disseminability of this novel intervention and heightening its public health impact nationally and internationally.

Project Narrative Approximately 40% of persons with opioid use disorder seeking addiction treatment with buprenorphine have pain that interferes with daily activities, affects drug treatment outcomes, and often co-occurs with depression. This project will develop a novel collaborative treatment, in which behavioral health specialists and primary care providers share a unified plan for addressing pain and depression in patients receiving buprenorphine in office-based settings. This collaborative therapy, entitled TOPPS (Treating Opioid Patients' Pain and Sadness), builds upon behavior therapy that targets a reduction in behavioral avoidance and an increase in behavioral activation, and would be the first empirically-tested therapy protocol that specifically integrates treatment of pain and depression for opioid populations.