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）已被证明可以减少阿片类药物的使用， 然而，长期保留MAT护理往往是次优的。抑郁症，阿片类药物的耻辱 使用和成瘾，以及有限的自我效能感来应对生活挑战，已被证明有助于MAT 脱离接触行为激活（BA）疗法是一种基于证据的行为治疗， 在不同的吸烟人群中有效治疗抑郁症和药物使用的共病， 酒精、兴奋剂和多种物质使用障碍概念模型。BA背后的概念模型 假设自我挫败的行为，如物质使用和行为回避的健康促进 资源的功能是应对负面情绪，使个人在短期内感觉更好， 但最终会通过负面强化的过程加剧抑郁。BA利用治疗 帮助患者逐渐增加目标导向、潜在回报和愉悦活动的技术 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采用的策略可以支持个人缓解抑郁症，科普耻辱， 培养应对生活挑战的能力，将BA与MAT配对有助于确保持续参与 在护理和改善阿片类药物使用障碍的个人的治疗结果。研究概述。 根据NIH心理社会治疗开发和测试的阶段模型，本研究旨在 确定研究程序的可行性，提高参与者的可接受性，并提供初步的 有效性数据，以支持提交一项全面的NIH R 01有效性试验。我们将招募80名 目前正在接受MAT治疗阿片类药物使用障碍的试点随机对照试验（RCT）， CoMBAT（联合药物和行为激活治疗）干预。在随机化之前， 参加者将接受2次健康导航和标准药物滥用咨询课程。参与者 然后将被随机分为：1）6次CoMBAT干预;或2）单独MAT（治疗为- 通常）。主要结局是保留MAT护理。次要结果包括阿片类药物使用天数， 阿片样物质阳性尿分析，和潜在的介质（例如，抑郁症，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） 基线干预，3个月和6个月。还将评估干预的可行性和可接受性。 本研究将提供必要的数据，为将来在大规模R 01中进行干预的有效性测试提供信息 试验，最终目标是开发一种有效的干预措施来解决阿片类药物的流行。

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.