Treatment of Smoking Among Individuals with PTSD

描述（由申请人提供）：本研究将评估一项针对创伤后应激障碍（PTSD）吸烟者的创新计划，该计划将最有效的戒烟药物（伐尼克兰）与长时间暴露（PE）相结合，这是一种高效的PTSD认知行为疗法。已确定为公共卫生政策的一项高度优先事项，是为患有精神疾病的吸烟者开发专门定制的和更有效的戒烟治疗方法，这些吸烟者的吸烟率过高。创伤后应激障碍是一种常见的精神障碍，终生患病率为6.8%。当前PTSD患者的吸烟率为44.6%，是无心理障碍史患者（22.5%）的两倍。患有创伤后应激障碍的吸烟者更有可能依赖尼古丁，吸烟严重，经历更严重的戒断症状，并在戒烟后复发。事实上，与其他精神疾病相比，患有创伤后应激障碍的吸烟者的戒烟率是最低的。可能导致吸烟者发展为尼古丁依赖和复吸的因素包括负面影响、恐惧、焦虑敏感性、觉醒增强、易怒和愤怒。因此，假设将戒烟治疗与创伤后应激障碍治疗相结合，减少这些因素，以提高患有创伤后应激障碍的吸烟者的戒烟成功率。为了验证这一假设，我们将随机分配患有创伤后应激障碍的吸烟者，要么单独使用“最佳实践”药物治疗戒烟（伐尼克兰），要么将伐尼克兰与PE结合治疗。主要结局指标将是治疗结束时和戒烟后6个月随访时生化证实的戒断率。次要观察指标为持续戒断、长期戒断和复发时间。我们还将获得创伤后应激障碍和相关精神病理（如抑郁和焦虑）和危险因素（如焦虑敏感性）的测量。总的来说，我们的研究小组在开发有效的创伤后应激障碍治疗方面拥有专业知识，包括PE (Foa, Cahill, Hembree)，吸烟和精神疾病的流行病学（Breslau）和戒烟（Lerman， O'Brian, Gariti）。拟议的研究提供了一个独特的机会，将来自不同领域的专家结合起来，目的是开发一种创新的、综合的方法来治疗那些使用现有治疗方法可能失败的人。公共卫生相关性：在美国，吸烟是导致过早死亡的最可预防的单一原因；大约50%的长期吸烟者死于由其依赖引起的疾病，平均缩短13-14年的寿命。与没有创伤后应激障碍的吸烟者相比，患有创伤后应激障碍（PTSD）的吸烟者更有可能对尼古丁依赖，吸烟严重（每天25支或更多），经历更严重的戒断症状，并且在戒烟后复发。在这项拨款申请中，我们建议评估一项针对患有创伤后应激障碍的吸烟者的创新治疗方案，该方案将最有效的戒烟药物伐尼克兰与长期暴露疗法结合起来，这是一种非常有效的创伤后应激障碍心理治疗形式。

DESCRIPTION (provided by applicant): This study will evaluate an innovative program for smokers with Post-Traumatic Stress Disorder (PTSD) that integrates the most effective medication for smoking cessation (varenicline) with prolonged exposure (PE), a highly efficacious cognitive behavioral therapy for PTSD. The development of specifically tailored and more efficacious smoking cessation treatments for smokers with psychiatric disorders, whose cigarette smoking is disproportionately high, has been identified as a high priority in public health policy. PTSD is a common mental disorder with a lifetime prevalence of 6.8%. The prevalence of smoking in people with current PTSD is 44.6% -- double the rate of those with no history of a psychological disorder (22.5%). Smokers with PTSD are more likely to be nicotine dependent, smoke heavily, experience more severe withdrawal symptoms, and relapse after a quit attempt. In fact, the quit rate for smokers with PTSD is among the lowest compared to other mental disorders. Factors that may contribute to smokers' progression to nicotine dependence and relapse include negative affect, fear, anxiety sensitivity, increased arousal, irritability, and anger. Therefore, the integration of treatment for smoking cessation with treatment for PTSD that reduces these factors is hypothesized to improve success of smoking cessation about smokers with PTSD. To test this hypothesis, we will randomly assign smokers with PTSD to either the "best practice" pharmacotherapy for smoking cessation (varenicline) alone or to a treatment that integrates varenicline with PE. The primary outcome measure will be biochemically confirmed abstinence rates at the end of treatment and at follow-up 6-months post quit date. Secondary outcome measures will be continuous abstinence, prolonged abstinence, and time to relapse. We will also obtain measures of PTSD and associated psychopathology (e.g. depression and anxiety) and risk factors (e.g. anxiety sensitivity). Collectively, our research group has expertise in the development of efficacious treatments for PTSD, including PE (Foa, Cahill, Hembree), the epidemiology of smoking and psychiatric disorders (Breslau), and smoking cessation (Lerman, O'Brian, Gariti). The proposed research affords a unique opportunity to combine experts from diverse areas with the aim of developing an innovative, integrated approach to the treatment of people who are likely to fail using existing treatments. PUBLIC HEALTH RELEVANCE: Cigarette smoking is the single most preventable cause of premature death in the US; approximately 50% of long-term smokers die of a disease caused by their dependence, shortening lives by an average of 13-14 years. Smokers with Post Traumatic Stress Disorder (PTSD) are more likely to be nicotine dependent, to smoke heavily (25 cigarettes per day or more), experience more severe withdrawal symptoms, and relapse following a quit attempt than smokers without PTSD. In this grant application, we propose to evaluate an innovative treatment program for smokers with PTSD that integrates varenicline, the most effective medication for smoking cessation, with prolonged exposure therapy, a highly effective form of psychotherapy for PTSD.