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

项目总结/摘要 阿片类药物的滥用在美国已经达到流行病的程度，大约有200万人 2019年，阿片类药物使用障碍和超过46，800例阿片类药物过量死亡。基于药物 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，接受丁丙诺啡治疗的人中约有一半没有充分反应或退出治疗， 治疗与其他物质使用障碍相反，在丁丙诺啡中加入行为疗法， 阿片类药物使用障碍的阿片类药物使用结局未持续改善。初步证据 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。理解能力 对阿片类药物使用障碍治疗反应的异质性受到需要非常大样本的阻碍 大小来测试有关治疗反应调节剂的问题。了解子组差异可以 最终为阿片类药物使用障碍的治疗提供个性化的医学方法。我们的目标是 这项建议是通过协调行为治疗的亚组反应来回答迫切的问题， 数据来自4项已完成的阿片类药物使用障碍治疗临床试验。这些由NIDA资助的随机试验 每项研究都测试了行为疗法加丁丙诺啡维持治疗阿片类药物使用障碍的疗效， 包括共同数据要素，使其协调一致。我们的项目目标包括：（1）识别 在阿片类药物使用的丁丙诺啡维持治疗基础上添加行为治疗后有应答的亚组 （2）量化行为疗法改善丁丙诺啡治疗保留的疗效，以及 (3)来量化行为疗法对功能结果的有效性。这项研究的结果将提供 关于谁对行为治疗有反应以及行为治疗对非阿片类药物的影响的重要信息 使用端点。我们的建议将利用经过充分验证的纵向数据分析方法，包括严格的 数据缺失的方法。通过使用现有的数据集，该建议提供了一种有效的方式来回答紧急 关于阿片类药物使用障碍的治疗问题，并为这些试验提供了显着的附加值。这些 研究结果可以立即用于告知阿片类药物使用障碍的个性化治疗方法， 也将有助于理解行为疗法对患者感兴趣的终点的影响， 家庭

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.