Combining Topiramate and Prolonged Exposure for PTSD and Alcohol Use Disorder

目标。酒精使用障碍(AUD)和创伤后应激障碍(PTSD)经常并存， 其中一种情况会使另一种情况恶化。患有这两种疾病的人表现得更差 比单独患有任何一种障碍的人在多个领域发挥作用的人更多。长时间暴露 治疗(PE)是治疗创伤后应激障碍最有效的方法之一。体育已被评为一线治疗 包括VA/DoD治疗创伤后应激障碍的临床实践指南在内的多项指南和审查。 然而，在对PTSD和AUD患者的研究中，酒精使用的变化仅略好于 在对照或标准护理条件下，创伤后应激障碍症状的减少与PE研究相比是适度的 无AUD的创伤后应激障碍患者，退出治疗的比例较高。将PE与药物结合起来 遏制饮酒表明有望提高体育锻炼对患有澳门氏症和糖尿病的患者的有效性 创伤后应激障碍，尽管到目前为止很少有研究研究将心理治疗和药物治疗结合起来。托吡酯是 单一药物对AUD和PTSD都有效，并显示出减少 患有澳门氏症和创伤后应激障碍的人饮酒。但在PE中加入托吡酯的治疗效果 并存的澳元/创伤后应激障碍尚待检查。关键的下一步是测试最佳的创伤后应激障碍治疗方法， PE与一种很有前途的药理学试剂托吡酯一起使用，已被发现对 澳元和创伤后应激障碍。创新：这项应用寻求改变当前的临床实践范式。一个 建议通过整合两种基于证据的治疗来改进现有的干预措施。 方法论。我们建议使用随机、对照、双盲研究设计来检查 在PTSD、PE的最佳治疗方案中加入托吡酯(上)的效果。参赛者为120名男性和 所有军种的退伍军人都患有澳元和创伤后应激障碍。我们的主要目标是确定相对疗效 与PE+安慰剂相比，PE+托吡酯在减少有问题的饮酒，减少创伤后应激障碍症状， 改善患有AUD/PTSD的退伍军人的功能和生活质量 治疗后随访3个月和6个月。我们将探索饮酒和创伤后应激障碍的减少程度 症状会导致功能的改善。 这项拟议的研究有可能改善高度中风患者的功能和心理恢复 退伍军人中普遍存在和高度受损的人群。这项研究将测试一种新颖而创新的组合 心理治疗和药物治疗，目的是改善对退伍军人的护理。圆满完成 该项目将有助于改变推动对患有AUD和PTSD的退伍军人进行治疗的做法。 这项研究的基本原理是改进证据基础，以告知AUD患者如何 创伤后应激障碍可以从这两种疾病中获得持续的康复。我们还将探索变化是否 在创伤后应激障碍中，PE+TOP状态下的症状部分可以通过酒精渴望的减少来解释。 诺曼-1

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