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: 10515328
• 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 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10515328
• 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， 一种情况会使另一种情况恶化。患有这两种疾病的个体表现更差 与单独患有任何一种疾病的人相比，他们在多个领域都有功能。长期接触 治疗（PE）是治疗 PTSD 最有效的方法之一。 PE 被评为一线治疗方法 多个指南和评论，包括 VA/DoD 治疗 PTSD 的临床实践指南。 然而，在对患有 PTSD 和 AUD 的个体的研究中，饮酒的变化仅比酒精使用的变化稍好一些。 与在对照或标准护理条件下进行的 PE 研究相比，PTSD 症状的减轻幅度不大 没有 AUD 的 PTSD 患者，退出治疗的比例很高。 PE 与药物相结合 限制饮酒表演有望提高患有 AUD 和 创伤后应激障碍（PTSD），尽管迄今为止很少有研究将心理治疗和药物治疗结合起来。托吡酯是 该单一药物已显示出对 AUD 和 PTSD 均有效，并有望减少 患有 AUD 和 PTSD 的人饮酒。然而，在PE中添加托吡酯来治疗的效果 共病 AUD/PTSD 尚未得到检查。下一步关键是测试 PTSD 治疗的最佳实践， PE 与一种有前途的药物托吡酯一起使用，已被发现对以下疾病有效： 澳元和创伤后应激障碍。创新：该应用程序旨在改变当前的临床实践范式。一个 建议通过整合两种基于证据的治疗方法来完善现有干预措施。 方法论。我们建议使用随机、对照、双盲研究设计来检验 将托吡酯 (TOP) 添加到 PTSD、PE 最佳实践治疗中的效果。参与者将包括 120 名男性和 来自所有军种且患有 AUD 和 PTSD 的女性退伍军人。我们的主要目标是确定相对功效 与 PE+安慰剂相比，PE+托吡酯在减少饮酒问题、减少 PTSD 症状方面的效果 改善患有 AUD/PTSD 共病的退伍军人在治疗后和治疗后的功能和生活质量 治疗后3个月和6个月的随访。我们将探讨饮酒和创伤后应激障碍的减少程度 症状会导致功能改善。 拟议的研究有可能改善高度功能和心理恢复 退伍军人中普遍存在且高度受损的人群。这项研究将测试一种新颖且创新的组合 心理治疗和药物治疗，旨在改善退伍军人的护理。顺利完成 该项目将有助于改变对患有 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善证据基础，告知 AUD 患者如何 创伤后应激障碍（PTSD）可以从这两种疾病中持续康复。我们还将探讨是否会改变 PE+TOP 状态下的 PTSD 症状部分可以通过酒精渴望的减少来解释。 诺曼 - 1

项目成果

Resting-state connectivity subtype of comorbid PTSD and alcohol use disorder moderates improvement from integrated prolonged exposure therapy in Veterans.

共病 PTSD 和酒精使用障碍的静息态连接亚型可缓和退伍军人综合长期暴露疗法的改善。

• 发表时间: 2023-01
• 影响因子: 6.9
• 作者: Stout, Daniel M;Harlé, Katia M;Norman, Sonya B;Simmons, Alan N;Spadoni, Andrea D
• 通讯作者: Spadoni, Andrea D

The mental health impact of COVID-19-related stressors among treatment-seeking trauma-exposed veterans.

COVID-19 相关压力源对寻求治疗的遭受创伤的退伍军人的心理健康影响。

• 发表时间: 2022-12
• 影响因子: 3.3
• 作者: McLean, Carmen P;Wachsman, Tamara;Morland, Leslie;Norman, Sonya B;Hooper, Vaughan;Cloitre, Marylene
• 通讯作者: Cloitre, Marylene