Distress Tolerance and Benzodiazepine Discontinuation in Opioid Agonist Therapy

项目总结/摘要 这个K23奖的目标是提供博士Tae Woo Park，成瘾精神病学家和助理 波士顿大学医学院精神病学教授，经过必要的培训， 他本人作为一名独立的临床研究者，致力于减少处方药滥用的风险。 该K23奖项的重点是开发和评估基于痛苦耐受（DT）的治疗方法， 在接受阿片类激动剂治疗（OAT）的患者中停用苯二氮卓类药物（BZD）。饰Dr. Park 将是一个多学科专家在物质使用障碍（SUD）研究的本地团队。朴医生的第一次 导师Richard Saitz博士是成瘾医学医生和随机对照试验（RCT）专家 包括对SUD患者的心理社会和药物干预。导师是博士。 Michael Otto，临床心理学家，BZD停药和基于DT的心理社会学专家 Mari-Lynn Drainoni博士是SUD研究中使用混合方法的专家， 霍华德卡布拉尔，一个统计学家和RCT数据和中介分析专家，杰弗里萨梅特博士，一个 具有丰富指导经验的成瘾医学医生兼科学家。朴医生的训练目标 包括：1）发展干预发展方面的专门知识，包括定性研究方法，2）培训 在SUD人群的RCT方法中，3）学习统计分析的新方法，4）增强 研究职业技能，包括手稿写作和获得技能的granecraft。 BZD的使用在OAT患者中很常见，与过量死亡和OAT治疗减少相关 潴留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，以帮助OAT BZD停药的患者。该计划包括三个阶段。在第1阶段（第1年和第2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，以开发一个12周的痛苦容忍的原型手册 BZD停药治疗（DT-BD）和健康教育控制疾病（HE）。第二阶段（年 2），我们将在10名接受OAT的参与者中试行这些干预措施，这些参与者经常使用BZD并使用数据 从干预后的访谈中提炼出这些条件。在第3阶段（3-5年），我们将测试DT-BD 在50名额外参与者的初步RCT中进行干预。受试者将被随机分配至DT-BD + a组 BZD锥体（n = 25）或BZD锥体+ HE（n = 25）。评估将在基线时进行，在12- 18个月期间每周进行一次。 治疗1周，以及停药后1个月和3个月随访。主要结果将是 通过尿液检测确认的自我报告确定的BZD成功停药。次要结局 通过自我报告的BZD使用变化以及通过自我报告和行为DT测量的DT变化。我们将 探索可能解释DT干预有效性的潜在机制。这项研究的结果将 用于改进DT-BD干预，以便作为R 01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.