Combining Topiramate and Prolonged Exposure for PTSD and Alcohol Use Disorder

结合托吡酯和长期暴露治疗创伤后应激障碍和酒精使用障碍

• 批准号: 10038741
• 负责人: SONYA NORMAN
• 金额: --
• 依托单位: VA SAN DIEGO HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-11-01 至 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10038741
• 关键词: Aftercare; Alcohol abuse; Alcohol consumption; Caring; Clinical Practice Guideline; Disease; Distress; Double-Blind Method; Drops; Effectiveness; Evidence based treatment; Exhibits; Female; Goals; Grant; Guidelines; Heavy Drinking; Impairment; Individual; Intervention; Lead; Mediating; Methodology; Participant; Patients; Pharmaceutical Preparations; Pharmacology; Placebos; Post-Traumatic Stress Disorders; Psychotherapy; Quality of life; Randomized; Recovery; Relapse; Research; Research Design; Sampling; Services; Symptoms; Testing; Treatment outcome; Veterans; active method; alcohol comorbidity; alcohol craving; alcohol use disorder; associated symptom; clinical practice; cognitive function; depressive symptoms; design; drinking; effective therapy; efficacy trial; evidence base; follow-up; functional disability; improved; improved functioning; innovation; male; military veteran; novel; psychologic; reduce symptoms; reduced alcohol use; standard care; topiramate; treatment comparison; treatment guidelines

Objectives. Alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) frequently co-occur, and having one condition worsens the course of the other. Individuals with both disorders exhibit worse functioning across a number of domains than individuals with either disorder alone. Prolonged exposure therapy (PE) is among the most effective treatments for PTSD. PE has been rated as a frontline treatment by multiple guidelines and reviews including the VA/DoD Clinical Practice Guidelines for the treatment of PTSD. However, in studies of individuals with PTSD and AUD, changes in alcohol use are only slightly better than in control or standard care conditions, reductions in PTSD symptoms are modest relative to studies of PE in PTSD patients without AUD, and rates of drop out from treatment are high. Combining PE with medication to curb drinking shows promise to improve upon the effectiveness of PE for individuals with comorbid AUD and PTSD, although thus far few studies have examined combining psychotherapy and medication. Topiramate is the single medication that has shown effectiveness for both AUD and PTSD and shows promise for reducing drinking among individuals with AUD and PTSD. However, the effect of adding topiramate to PE to treat comorbid AUD/PTSD has yet to be examined. The critical next step is to test a best practice PTSD treatment, PE, together with a promising pharmacological agent, topiramate, which has been found to be effective for both AUD and PTSD. Innovation: This application seeks to shift current clinical practice paradigms. A refinement to existing interventions is proposed through integration of two evidence based treatments. Methodology. We propose to use a randomized, controlled, double blind study design to examine the effect of adding topiramate (TOP) to a best practice treatment for PTSD, PE. Participants will be 120 male and female Veterans from all services with AUD and PTSD. Our primary aims are to determine the relative efficacy of PE+topiramate, as compared to PE+placebo, in reducing problematic drinking, reducing PTSD symptoms, and improving functioning and quality of life among Veterans with comorbid AUD/PTSD at post-treatment and 3- and 6-month post-treatment follow-up. We will explore the extent to which decreases in drinking and PTSD symptoms lead to improvement in functioning. The proposed study has the potential to improve functional and psychological recovery for a highly prevalent and highly impaired population of Veterans. This study will test a novel and innovative combination of psychotherapy and medication with the goal of improving the care of Veterans. The successful completion of this project will help change the practices that drive treatment for Veterans who have both AUD and PTSD. The fundamental rationale for this study is to improve the evidence base that informs how patients with AUD and PTSD can attain sustained recovery from both of these disorders. We will also explore whether changes in PTSD symptoms in the PE+TOP condition are partially explained by reductions in alcohol cravings. Norman - 1

目标。酒精使用障碍（AUD）和创伤后应激障碍（PTSD）经常共发生， 并且有一种条件使另一个状况恶化。两种疾病的人表现较差 比单独的任何一个疾病的个体在许多领域的运作。长期接触 治疗（PE）是PTSD最有效的治疗方法之一。 PE已被评为一线治疗 多个指南和评论，包括有关PTSD治疗的VA/DOD临床实践指南。 但是，在对有PTSD和AUD的个体的研究中，饮酒的变化仅比在 控制或标准护理条件，相对于PE的研究，PTSD症状的减少是适度的 没有AUD的PTSD患者，从治疗中辍学的率很高。将PE与药物结合到 遏制饮酒表明有望提高PE对合并AUD的人的有效性和 PTSD虽然迄今为止很少有研究检查了心理治疗和药物的结合。托吡酯是 对AUD和PTSD有效性显示的单一药物，并显示出减少的希望 有AUD和PTSD的人喝酒。但是，将托吡酯添加到PE治疗的效果 合并AUD/PTSD尚未检查。关键的下一步是测试最佳实践PTSD治疗， PE，以及有前途的药理学剂，托托拉mate，已被发现有效 AUD和PTSD。创新：该应用程序旨在改变当前的临床实践范例。一个 通过整合两种基于证据的治疗方法，提出了对现有干预措施的完善。 方法论。我们建议使用随机，受控的双盲研究设计来检查 将托吡酯（顶部）添加到PTSD的最佳实践治疗中的效果。参与者将为120名男性 来自AUD和PTSD的所有服务的女退伍军人。我们的主要目的是确定相对功效 与PE+安慰剂相比，PE+托吡酯的摄入量减少了有问题的饮酒，减少PTSD症状， 以及在治疗后的合并AUD/PTSD和PTSD和 治疗后的3个月和6个月。我们将探索饮酒和PTSD减少的程度 症状会改善功能。 拟议的研究有可能改善功能和心理恢复 退伍军人的流行和高度受损。这项研究将测试一种新颖而创新的组合 心理治疗和药物的目的是改善退伍军人的照顾。成功完成 该项目将有助于改变为拥有AUD和PTSD的退伍军人提供治疗的实践。 这项研究的基本原理是提高证据基础，以告知AUD患者如何 PTSD可以从这两种疾病中持续恢复。我们还将探索是否更改 在PE+最高状态下的PTSD症状中，通过饮酒的减少来部分解释。 诺曼-1