Department of Psychology, Clemson University, Clemson, SC 29634, USA.
Department of Public Health Sciences, Clemson University, Clemson, SC 29634, USA.
Contemp Clin Trials. 2020 Dec;99:106182. doi: 10.1016/j.cct.2020.106182. Epub 2020 Oct 17.
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.
阿片类药物滥用在美国已达到危机水平。基于正念的复发预防（MBRP）已被证明在治疗物质使用障碍方面是有效的，但针对阿片类药物使用障碍的应用研究有限，需要了解其潜在机制。本文概述了一项针对阿片类药物使用障碍的 MBRP 随机对照试验方案。MBRP 是一种团体康复后计划，将正念技能训练与认知行为复发预防策略相结合。我们将招募 240 名已完成阿片类药物使用障碍治疗的参与者，并将他们随机分配到为期 8 周的 MBRP 团体干预组或常规治疗（TAU）对照组。TAU 对照组将在 8 周后完成干预。评估将在基线、8 周和 16 周进行。主要结果是阿片类药物使用的频率。次要结果包括渴望和戒断症状、首次使用阿片类药物的时间、药物辅助治疗计划的依从性、感知压力、生活质量、创伤后应激症状和慢性疼痛。我们还将检查干预结果的以下潜在调节因素和相关性：共病诊断、生活事件史和 MBRP 干预依从性。此外，我们将检查干预结果的以下中介因素：正念技能、情绪调节技能、执行功能技能、享受、积极和消极情绪。这项研究将有助于为 MBRP 减少阿片类药物使用的疗效提供证据基础，并有助于了解物质使用障碍 MBRP 治疗结果的因果机制和调节因素。
