CoMBAT Opioid Use Disorder: A Pilot RCT of a Combined Medication Assisted and Behavioral Activation Treatment for People Living with Opioid use Disorder

阿片类药物使用障碍是一种慢性复发性疾病，是发病率和死亡率的主要来源。 在美国。药物辅助治疗(Mat)已被证明可以减少不同类型阿片类药物的使用。 然而，长期保留在垫子护理中往往是次优的。抑郁症，阿片类药物的耻辱 使用和上瘾，以及应对生活挑战的有限自我效能都被证明是导致MAT的原因 解脱。行为激活(BA)疗法是一种基于证据的行为疗法，已被 在治疗吸烟的不同人群中的共病抑郁和药物使用方面被证明是有效的， 酒精、兴奋剂和多物质使用障碍。概念模型。支持BA的概念模型 假设弄巧成拙的行为，如物质使用和行为回避促进健康 资源服务于应对负面情绪的功能，并在短期内让个人感觉更好， 但最终会通过负面强化的过程加剧抑郁。BA利用治疗性 帮助患者逐渐增加目标导向、潜在回报和愉快活动的技术 同时降低不良事件和后果的强度和频率，以改善情绪。 鉴于BA使用的策略可以支持个人缓解抑郁，应对耻辱，以及 建立应对生活挑战的能力，将BA与MAT配对有助于确保持续参与 护理和改善阿片类药物使用障碍患者的治疗结果。研究综述。 遵循NIH心理社会治疗发展和测试的阶段模式，本研究试图 确定研究程序的可行性，提高参与者的可接受性，并提供初步 疗效数据支持提交一项全面的NIH R01疗效试验。我们将招收80人 目前正在一项试点随机对照试验(RCT)中使用MAT治疗阿片类药物使用障碍 战斗(联合用药和行为激活治疗)干预。在随机化之前， 参与者将接受2次健康导航和标准药物滥用咨询会议。参与者 然后将被同样随机地分为：1)6次战斗干预；或2)单独进行MAT(视为- 通常情况下)。主要结果是在垫子护理中保留。次要结果包括阿片类药物的使用天数， 阿片类药物阳性尿检和潜在的介体(例如，抑郁、耻辱应对、自我效能)和 主持人(例如，共病精神健康、药物使用、刑事司法系统参与) 在基线、3个月和6个月进行干预。还将评估干预的可行性和可接受性。 这项研究将提供必要的数据，为未来在大规模R01中进行干预效果测试提供信息 试验的最终目标是制定一种有效的干预措施，以应对阿片类药物的流行。

Opioid use disorder is a chronic, relapsing disease and a major source of morbidity and mortality in the United States. Medication Assisted Treatment (MAT) has been shown to reduce opioid use in diverse populations; however, long-term retention in MAT care is often suboptimal. Depression, the stigma of opioid use and addiction, and limited self-efficacy to navigate life challenges have been shown to contribute to MAT disengagement. Behavioral activation (BA) therapy is an evidenced-based, behavioral treatment that has been shown to be effective in treating comorbid depression and substance use in diverse populations with smoking, alcohol, stimulant, and poly-substance use disorder. Conceptual Model. The conceptual model underlying BA posits that self-defeating behaviors, such as substance use and the behavioral avoidance of health-promoting resources serve the function of coping with negative feelings and make individuals feel better in the short-run, but ultimately exacerbate depression through a process of negative reinforcement. BA utilizes therapeutic techniques that help patients gradually increase goal-directed, potentially rewarding and pleasurable activities while decreasing the intensity and frequency of adverse events and consequences in order to improve mood. Given that BA utilizes strategies that can support individuals in alleviating depression, cope with stigma, and build the capacity to navigate life challenges, pairing BA with MAT could help to ensure continued engagement in care and improve treatment outcomes for individuals with opioid use disorder. Overview of Study. Following the NIH Stage Model of psychosocial treatment development and testing, this study seeks to determine the feasibility of study procedures, enhance participant acceptability, and provide preliminary efficacy data to support the submission of a full-scale, NIH R01 efficacy trial. We will enroll 80 individuals currently being treated with MAT for opioid use disorder in a pilot randomized controlled trial (RCT) of the CoMBAT (Combined Medication and Behavioral Activation Treatment) intervention. Prior to randomization, participants will receive 2 health navigation and standard substance abuse counseling sessions. Participants will then be equally randomized to either: 1) the 6-session CoMBAT intervention; or 2) MAT alone (treatmentas- usual). The primary outcome is retention in MAT care. Secondary outcomes include days of opioid use, opioid positive urinalysis, and potential mediators (e.g., depression, stigma coping, self-efficacy) and moderators (e.g., comorbid mental health, substance use, criminal justice system involvement) of the intervention at baseline, and 3- and 6-months. Intervention feasibility and acceptability will also be assessed. This study will provide the requisite data to inform future efficacy testing of the intervention in a large-scale R01 trial, with the ultimate goal of developing an efficacious intervention to address the opioid epidemic.