测试在丁丙诺啡中添加行为疗法治疗阿片类药物使用障碍的随机试验的统一协议

R. Kathryn McHugh , Allen J. Bailey , Roger D. Weiss , Garrett M. Fitzmaurice
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引用次数: 0

摘要

背景虽然丁丙诺啡是治疗阿片类药物使用障碍(OUD)的一种有效方法,但人们对治疗无应答以及提高治疗保持率的方法仍有很多不了解之处。平均而言,在丁丙诺啡的基础上增加行为疗法并没有为阿片类药物治疗结果带来一致的益处。不过,一些研究表明,某些亚群体可能会从丁丙诺啡与行为疗法的结合中获益,这凸显了个性化治疗方法的潜力。此外,人们对行为疗法是否能改善丁丙诺啡的保留率或非阿片类药物(如功能性药物)的疗效知之甚少。本项目的目的是协调之前进行的四项临床试验,这些试验测试了在丁丙诺啡维持治疗 OUD 的基础上增加行为疗法的情况,并利用这一更大的数据集来回答有关行为疗法在这一人群中的作用的关键临床问题。研究目的包括确定增加行为疗法效果的潜在调节因素,并量化行为疗法对丁丙诺啡维持治疗和功能性结果的影响。结果分析将考虑阿片类药物使用周数、丁丙诺啡维持治疗周数以及用成瘾严重程度指数衡量的功能性结果。分析将包括每项研究的指标,以考虑样本和设计的异质性。结论结果将有助于为临床和研究工作提供信息,优化行为疗法在治疗 OUD 中的应用。
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Protocol for harmonization of randomized trials testing the addition of behavioral therapy to buprenorphine for opioid use disorder

Background

Although buprenorphine is an effective treatment for opioid use disorder (OUD), much remains to be understood about treatment non-response and methods for improving treatment retention. The addition of behavioral therapies to buprenorphine has not yielded consistent benefits for opioid outcomes, on average. However, several studies suggest that certain subgroups may benefit from the combination of buprenorphine and behavioral therapy, highlighting the potential for personalized approaches to treatment. Furthermore, little is known about whether behavioral therapies improve buprenorphine retention or non-opioid (e.g., functional) outcomes.

Methods

The objective of this project is to harmonize four previously conducted clinical trials testing the addition of behavioral therapy to buprenorphine maintenance for OUD and to use this larger dataset to answer critical clinical questions about the role of behavioral therapy in this population. Study aims include identifying potential moderators of the effect of the addition of behavioral therapy and quantifying the effect of behavioral therapy on buprenorphine retention and functional outcomes.

Results

Analyses will consider outcomes of weeks of opioid use, weeks of retention in buprenorphine treatment, and functional outcomes as measured by the Addiction Severity Index. Analyses will include an indicator for each study to account for heterogeneity of samples and design.

Conclusion

Results will help to inform clinical and research efforts to optimize the use of behavioral therapies in the treatment of OUD.

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来源期刊
Drug and alcohol dependence reports
Drug and alcohol dependence reports Psychiatry and Mental Health
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