Study protocol for a randomized controlled trial of mindfulness-based relapse prevention for opioid use disorders

The opioid misuse epidemic has reached a crisis level in the United States. Though mindfulness-based relapse prevention (MBRP) has been shown as effective in treating substance use disorders, there is limited research on its application to opioid use disorders specifically, and there is a need to understand the underlying mechanisms. This paper outlines a protocol for a randomized controlled trial of MBRP for opioid use disorders. MBRP is a group aftercare program that integrates mindfulness skills training with cognitive-behavioral relapse prevention strategies. We will recruit 240 participants who have completed opioid use disorder treatment, and randomize them to an 8-week MBRP group intervention or treatment as usual (TAU) control group. The TAU control group will complete the intervention after 8 weeks. Assessments will take place at baseline, 8 weeks, and 16 weeks. The primary outcome is frequency of opioid use. The secondary outcomes include craving and withdrawal symptoms, time to first opioid use, adherence to medication-assisted treatment plans, perceived stress, quality of life, posttraumatic stress symptoms, and chronic pain. We will also examine the following potential moderators and correlates of intervention outcomes: comorbid diagnoses, life events history, and MBRP intervention adherence. In addition, we will examine the following mediators of intervention outcome: mindfulness skills, emotion regulation skills, executive functioning skills, savoring, and positive and negative affect. This study will contribute to the evidence base regarding MBRP's efficacy in reducing opioid use, as well as contribute to the understanding of the causal mechanisms and factors that modify treatment outcome for MBRP for substance use disorders.