Distress Tolerance and Benzodiazepine Discontinuation in Opioid Agonist Therapy

项目摘要/摘要 这个K23奖项的目标是为成瘾精神病学家和助理医生Tae Woo Park提供 波士顿大学医学院精神病学教授，经过必要的培训，建立 他本人是降低处方药滥用风险领域的独立临床调查员。 这项K23奖项的重点是开发和评估基于痛苦耐受性(DT)的治疗方法 接受阿片类激动剂治疗(OAT)的患者停用苯二氮(BZD)。协助朴医生 将是一个由物质使用障碍(SUD)研究的多学科专家组成的当地团队。帕克医生的初诊 导师理查德·赛茨博士是一位成瘾药物医师，也是随机对照试验(RCT)的专家。 包括对SUD患者进行心理社会和药理学综合干预。共同导师是Dr。 迈克尔·奥托，临床心理学家，BZD戒断和基于DT的心理社会专家 干预发展方面，Mari-Lynn Draoni博士是一位在SUD研究中使用混合方法的专家。 霍华德·卡布拉尔，统计学家和RCT数据和调解分析专家，杰弗里·萨梅特博士， 有丰富指导经验的成瘾医学内科医生兼科学家。朴博士的培训目标将是 涉及1)开发干预开发方面的专业知识，包括定性研究方法，2)培训 3)学习统计分析中的新方法，4)加强 研究职业技能，包括手稿写作和获得技能。 BZD在燕麦患者中很常见，并与过量死亡和减少燕麦治疗有关 留存。Park博士的研究计划建议开发和评估一种基于DT的干预措施来帮助OAT BZD患者停药。该计划包括三个阶段。在第一阶段(第一年和第二年)，我们将使用 定性方法确定患者(n=30)和临床医生(n=10)的干预偏好 结构化的定性访谈，以开发12周痛苦耐受性的原型手册 BZD停用治疗(DT-BD)和健康教育控制条件(HE)。在第二阶段(年 2)，我们将在10名经常使用BZD和使用数据的接受燕麦片的参与者中试点这些干预措施 从干预后的访谈到完善条件。在第3阶段(第3-5年)，我们将测试DT-BD 对另外50名参与者进行初步随机对照试验的干预。参与者将被随机分配到DT-BD+a BZD锥度组(n=25)或BZD锥度+HE组(n=25)。评估将在12个月内每周按基线进行- 治疗1周，停药后1个月和3个月随访。主要结果将是 成功停用BZD由尿检确认的自我报告确定。次要结果是 通过自我报告改变BZD的使用，通过自我报告和行为DT测量改变DT。我们会 探索可能解释DT干预效果的潜在机制。这项研究的结果将 用于改进DT-BD干预，以便可以作为R01应用程序的一部分在更大的试验中进行测试。

PROJECT SUMMARY/ABSTRACT The goal of this K23 award is to provide Dr. Tae Woo Park, an addiction psychiatrist and Assistant Professor of Psychiatry at Boston University School of Medicine, with the necessary training to establish himself as an independent clinical investigator in the field of reducing the risks of prescription drug misuse. This K23 award focuses on developing and evaluating a distress tolerance (DT)-based treatment for benzodiazepine (BZD) discontinuation in patients receiving opioid agonist therapies (OAT). Assisting Dr. Park will be a local team of multidisciplinary experts in substance use disorder (SUD) research. Dr. Park's primary mentor, Dr. Richard Saitz is an addiction medicine physician and expert in randomized controlled trials (RCTs) involving combined psychosocial and pharmacological interventions for SUD patients. Co-mentors are Dr. Michael Otto, a clinical psychologist and expert in BZD discontinuation and DT-based psychosocial intervention development, Dr. Mari-Lynn Drainoni, an expert in using mixed methods in SUD research, Dr. Howard Cabral, a statistician and expert in RCT data and mediation analyses, and Dr. Jeffrey Samet, an addiction medicine physician-scientist with extensive mentoring experience. Dr. Park's training goals will involve 1) developing expertise in intervention development including qualitative research methods, 2) training in RCT methodology with SUD populations, 3) learning new methods in statistical analyses, and 4) enhancing research career skills including manuscript writing and gaining skills in grantsmanship. BZD use is common in OAT patients and associated with overdose death and reduced OAT treatment retention. Dr. Park's research plan proposes to develop and evaluate a DT-based intervention to assist OAT patients with BZD discontinuation. The plan involves three phases. In Phase 1 (years 1 and 2), we will use qualitative methods to ascertain patients' (n=30) and clinicians' (n=10) intervention preferences with semi- structured qualitative interviews in order to develop a prototype manual for a 12-week Distress Tolerance treatment for BZD Discontinuation (DT-BD) and for a Health Education control condition (HE). In Phase 2 (year 2), we will pilot these interventions in 10 participants receiving OAT who are regularly using BZDs and use data from post-intervention interviews to refine the conditions. In Phase 3 (years 3-5), we will test the DT-BD intervention in a preliminary RCT of 50 additional participants. Participants will be randomized to DT-BD + a BZD taper (n = 25) or the BZD taper + HE (n = 25). Assessments will occur at baseline, weekly during the 12- week treatment, and at 1- and 3-month post-discontinuation follow-ups. The primary outcome will be successful BZD discontinuation determined by self-report confirmed by urine testing. Secondary outcomes are change in BZD use by self-report and change in DT by self-report and behavioral DT measures. We will explore potential mechanisms that may explain the efficacy of the DT intervention. The results of this study will be used to refine the DT-BD intervention so that it can be tested in a larger trial as part of an R01 application.