Abstract The national opioid epidemic requires development of real-world evidence based treatments for opioid use disorder, including adjuncts to Medication Assisted Treatment (MAT) with buprenorphine. Interventions are needed that address the complex needs of patients with opioid use disorder, which include substantial mental health co-morbidity and high rates of chronic pain related to the complex interaction of opioid prescribing for pain and opioid use disorder. This study takes advantage of recent federal and state opioid use disorder treatment initiatives as a platform for testing a promising mind-body intervention, Mindful Awareness in Body-oriented Therapy (MABT) as an adjunct to MAT in three clinical settings funded through the Washington Opioid State Targeted Response (STR) program. Each setting employs a variation of the nationally recognized Massachusetts Nurse Care Manager model. Using a randomized, repeated measures design, we will compare those who receive MABT+ MAT to MAT only. The overarching goal of this application is to test MABT to improve MAT outcomes among patients receiving buprenorphine to treat OUD. The primary aims for this R01 study extend the final outcome to 12 months, but are otherwise the same as the parent R33. The first aim is to evaluate the effectiveness of MABT + MAT compared to MAT only (treatment-as- usual) in reducing opioid use (primary hypothesis) and non-opioid substance use (secondary hypothesis) at 12 months. Aim 2 will examine the effectiveness of MABT + MAT to improve mental and physical health distress (i.e. symptoms of depression and anxiety; emotional well- being, and physical symptoms and pain severity/interference) compared to MAT only at 12 months. Aim 3 will examine the effectiveness of MABT + MAT compared to MAT only to positively affect substance use related outcomes such as craving and treatment retention at 12 months. An additional exploratory aim (Aim 4) will explore the effectiveness of an increased MABT dose for MABT non-responders. Results of this study will inform the evidence base for behavioral treatment adjuncts to MAT with buprenorphine and directly impact the future direction of opioid use disorder treatment in Washington State.

Narrative Medication Assisted Treatment of opioid use disorder with buprenorphine is an effective intervention to address the opioid epidemic, but additional treatments are necessary to optimize treatment outcomes and increase treatment retention. Mindful Awareness in Body-oriented Therapy (MABT) is an innovative intervention designed to teach body awareness skills to better manage key risks of relapse to substance use such as affective distress, emotion regulation, and the stress of chronic pain. This clinical trial will test MABT in real-world opioid use disorder treatment programs implemented through the Washington State Opioid Targeted Response program in both urban and rural settings.