The Role of Behavior Therapy Combined with Buprenorphine for the Treatment of Opioid Use Disorder

项目摘要/摘要 阿片类药物滥用在美国已达到流行程度，约有200万人 2019年，患有阿片使用障碍和超过46,800人死于阿片类药物过量。以药物为基础 阿片类药物使用障碍的治疗--如丁丙诺啡维持--是有效的，可以挽救生命， 然而，在接受丁丙诺啡治疗的患者中，大约有一半的人没有充分的反应或退出 治疗。与其他物质使用障碍不同的是，丁丙诺啡的行为疗法有 阿片类药物使用障碍的阿片类药物使用结果并没有一直显示出改善。初步证据 这表明，并不是每个人都需要在丁丙诺啡的基础上增加行为疗法来减少阿片类药物的使用， 但某些亚群的人可能会从行为疗法中受益。理解的能力 阿片类药物使用障碍治疗的异质性因需要非常大的样本而受到阻碍 大小以测试有关治疗反应的主持人的问题。了解子组差异可以 最终告知治疗阿片类药物使用障碍的个性化药物方法。我们的目标是 这项建议是为了回答关于亚群对行为疗法的反应的紧急问题，通过协调 来自4个已完成的阿片类药物使用障碍治疗临床试验的数据。这些由NIDA资助的随机试验 他们都测试了在丁丙诺啡维持治疗阿片类药物使用障碍的基础上加用行为疗法的疗效。 包括共同数据元素，以使其能够协调一致。我们的项目目标包括：(1)确定 在丁丙诺啡维持阿片类药物使用时对行为治疗有反应的亚组 精神障碍，(2)量化行为疗法改善丁丙诺啡治疗保留的疗效，以及 (3)量化行为疗法对功能结局的疗效。这项研究的结果将提供 关于谁对行为疗法有反应以及行为疗法对非阿片类药物的影响的重要信息 使用端点。我们的提案将利用经过充分验证的纵向数据分析方法，包括严格的 处理丢失数据的方法。通过使用现有数据集，该建议提供了一种有效的方式来回答紧急情况 关于阿片类药物使用障碍治疗的问题，并为这些试验提供了显著的附加值。这些 研究结果可以立即被用来为阿片类药物使用障碍的个性化治疗提供参考 也将有助于理解行为疗法对患者感兴趣的终点的影响 家人。

Project Summary/Abstract The misuse of opioids has reached an epidemic level in the United States, with approximately 2 million people suffering from opioid use disorder and over 46,800 opioid overdose fatalities in 2019. Medication-based treatment for opioid use disorder—such as buprenorphine maintenance—is effective and can save lives, however, approximately half of people who receive buprenorphine do not adequately respond or drop out of treatment. In contrast to other substance use disorders, the addition of behavior therapy to buprenorphine has not consistently shown improvements in opioid use outcomes for opioid use disorder. Preliminary evidence suggests that not everyone may need the addition of behavior therapy to buprenorphine to reduce opioid use, but that certain subgroups of people may benefit from behavior therapy. The ability to understand heterogeneity in response to treatment for opioid use disorder is hampered by the need for very large sample sizes to test questions about moderators of treatment response. Understanding subgroup differences can ultimately inform personalized medicine approaches to the treatment of opioid use disorder. Our objective for this proposal is to answer urgent questions about subgroup responses to behavioral therapy by harmonizing data from 4 completed clinical trials of treatment for opioid use disorder. These NIDA-funded randomized trials each tested the efficacy of behavior therapy added to buprenorphine maintenance for opioid use disorder and include common data elements, allowing for their harmonization. Our project aims include: (1) to identify subgroups who respond to behavior therapy when added to buprenorphine maintenance for opioid use disorder, (2) to quantify the efficacy of behavior therapy for improving buprenorphine treatment retention, and (3) to quantify the efficacy of behavior therapy for functional outcomes. The results from this study will provide important information about who responds to behavior therapy and the effect of behavior therapy on non-opioid use endpoints. Our proposal will utilize well-validated longitudinal data analysis methods, including a rigorous approach to missing data. By using existing datasets, this proposal provides an efficient way to answer urgent questions about the treatment of opioid use disorder and provides significant added value to these trials. These findings can be immediately used to inform personalized approaches to treatment for opioid use disorder and will also contribute to understanding of the impact of behavior therapy on endpoints of interest to patients and families.