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: 10383131
• 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 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10383131
• 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）经常同时发生， 一种情况会影响另一种情况的发展患有这两种疾病的人表现出更差的 在许多领域的功能比单独患有任何一种疾病的人。长时间暴露 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VA/DoD临床实践指南治疗PTSD。 然而，在对PTSD和AUD患者的研究中，酒精使用的变化仅略好于 对照或标准护理条件下，PTSD症状的减少相对于 没有AUD的创伤后应激障碍患者的治疗退出率很高。体育与药物相结合， 控制饮酒有望改善合并AUD患者的PE效果， 创伤后应激障碍，虽然到目前为止很少有研究已经检查了心理治疗和药物治疗相结合。托吡酯 单一药物对AUD和PTSD都显示出有效性，并显示出减少 在患有AUD和PTSD的人中饮酒。然而，在PE治疗中加入托吡酯的效果 AUD/PTSD共病尚待检查。关键的下一步是测试创伤后应激障碍的最佳治疗方法， PE与一种有前途的药理学药物托吡酯一起，已发现托吡酯对 都是创伤后应激障碍创新：该应用程序旨在改变当前的临床实践模式。一 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改进。 方法论我们建议采用随机、对照、双盲研究设计， 将托吡酯（TOP）添加到PTSD，PE的最佳实践治疗中的效果。参与者将是120名男性和 所有服务的女性退伍军人都患有AUD和PTSD。我们的主要目的是确定 与PE+安慰剂相比，PE+托吡酯在减少酗酒，减少PTSD症状， 改善治疗后合并AUD/PTSD的退伍军人的功能和生活质量， 3-治疗后6个月随访。我们将探讨饮酒和创伤后应激障碍的减少程度 症状导致功能改善。 这项研究有可能改善功能和心理恢复， 退伍军人的普遍和高度受损的人口。这项研究将测试一种新颖的和创新的组合， 心理治疗和药物治疗，目的是改善退伍军人的护理。圆满完成 这个项目将有助于改变那些同时患有AUD和PTSD的退伍军人的治疗方法。 这项研究的基本原理是改善证据基础，告知AUD患者如何 创伤后应激障碍可以从这两种疾病中持续恢复。我们还将探讨 在PE+TOP条件下的PTSD症状中，酒精渴望的减少可以部分解释。 诺曼-1