Abstract:
The risks of concomitant benzodiazepine (BZ) and opioid use are significant. Despite the urgent need to reduce BZ use among patients taking opioids, no treatment intervention research to our knowledge has addressed treatment for this concurrent, high-risk use. The current study will evaluate the efficacy of augmenting BZ taper procedures with CBT for anxiety disorders that has been adapted specifically for patients with concomitant BZ and opioid use (either use as prescribed or misuse), a high-risk patient population. Research combining rapidly scalable behavioral interventions ancillary to pharmacological approaches delivered via telehealth in primary care settings is innovative and important given concerning trends in rising prevalence of BZ/opioid co-prescription, BZ-associated overdose deaths, and known barriers to implementation of behavioral health interventions in primary care. CBT delivery using telehealth has the potential to aid adherence and promote access and dissemination of procedures in primary care. Lastly, the current study will utilize an experimental therapeutics approach to preliminarily explore the mechanism of action for the proposed interventions. The overall aim of the present pilot randomized controlled trial is to examine the feasibility and preliminary efficacy of a BZ taper with CBT for anxiety disorders adapted for patients with concomitant BZ (BZT + CBT) and opioid use to a BZ taper with a control health education program (BZT + HE) in a sample of individuals (N = 54) who have been prescribed and are taking benzodiazepines and opioids for at least 3 months prior to baseline and experience anxious distress. Screening and outcome measures, methods, and implications are described. Trial Registration: ClinicalTrials.gov (NCT05573906).
摘要:
同时使用苯二氮卓类药物(BZ)和阿片类药物的风险很大。尽管迫切需要减少服用阿片类药物的患者使用BZ,据我们所知,没有治疗干预研究解决了这种并发的治疗问题,高风险使用。目前的研究将评估用CBT增强BZ锥度手术对焦虑症的疗效,这些焦虑症专门针对伴随BZ和阿片类药物使用的患者进行了调整(按处方使用或误用),高危患者人群。考虑到BZ/阿片类药物共同处方患病率上升的趋势,将快速可扩展的行为干预措施与初级保健环境中通过远程保健提供的药理学方法相结合的研究是创新和重要的。BZ相关的过量死亡,以及在初级保健中实施行为健康干预措施的已知障碍。使用远程医疗提供CBT有可能帮助坚持并促进初级保健程序的获取和传播。最后,本研究将利用实验治疗方法来初步探索拟议干预措施的作用机制。本试点随机对照试验的总体目标是研究BZ锥度与CBT治疗焦虑症的可行性和初步疗效,该焦虑症适用于伴有BZ(BZTCBT)和阿片类药物的患者,并通过对照健康教育计划(BZTHE)在经历痛苦和焦虑前至少3个月服用苯二氮卓类药物和阿片类药物的样本(N=54)中。筛查和结果措施,方法,和含义进行了描述。试验注册:ClinicalTrials.gov(NCT05573906)。