Enhancing Panic and Smoking Reduction Treatment with D-Cycloserine

使用 D-环丝氨酸增强恐慌和减少吸烟治疗

• 批准号: 8731846
• 负责人: Michael W. Otto
• 金额: $ 20.26万
• 依托单位: UNIVERSITY OF TEXAS AT AUSTIN
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-15 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8731846
• 关键词: Abstinence; Acute; Address; Adult; Affect; Anxiety; Anxiety Disorders; Attention; Basic Science; Behavioral; Caring; Clinical Research; Cognitive; Cognitive Therapy; Combined Modality Therapy; Cycloserine; Data; Distress; Education; Exercise; Extinction (Psychology); Failure; Frequencies; Goals; Intervention; Investigation; Lead; Left; Link; Literature; Maintenance; Mediating; Mediation; Mediator of activation protein; Mental Depression; Modeling; Morbidity - disease rate; Nicotine Dependence; Nicotine Withdrawal; Outcome; Outcome Measure; Panic; Panic Attack; Panic Disorder; Pathway interactions; Persons; Pharmacotherapy; Phase; Placebos; Population; Prevalence; Process; Protocols documentation; Psychopathology; Public Health; Randomized; Randomized Clinical Trials; Recording of previous events; Recruitment Activity; Relapse; Relative (related person); Research; Research Personnel; Risk; Role; Severities; Smoker; Smoking; Smoking Cessation Intervention; Staging; Testing; Time; Tobacco; Tobacco use; Translating; Translational Research; Treatment outcome; Withdrawal Symptom; Withholding Treatment; Work; base; disorder later incidence prevention; efficacy testing; evidence base; experience; follow-up; improved; meetings; mortality; nicotine replacement; pill; primary outcome; programs; psychoeducation; psychosocial; public health relevance; smoking cessation; smoking relapse; success; treatment program

DESCRIPTION (provided by applicant): Approximately 9-15 million smokers in the U.S. meet criteria for at least one anxiety disorder during their lifetime (Kessler et al., 2005) and these persons experience significant challenges quitting tobacco (Piper et al., 2010a; Zvolensky et al., 2008). Yet, little attention has been given to the maintenance of tobacco use among persons with anxiety disorders, and in particular, smokers with a history of panic attacks. This group is especially important to study because research shows that they have significantly lower quit rates than smokers with no history of panic attacks, and that they respond the same to placebo, single cessation, and combination cessation pharmacotherapy (Piper et al., 2010a). The goal of the current research is to pilot test the efficacy of the addition of d-cycloserine (DCS) versus pil placebo to a cognitive-behavioral program (CBT) targeting the role of anxiety sensitivity, distress intolerance, and panic attacks in smoking maintenance. The proposed project builds directly from our basic and clinical research as well as corresponding pilot work on (a) tobacco-panic relations; (b) intensive cognitive-behavioral intervention (CBT) for panic- and anxious-prone smokers; and (c) DCS enhancement of CBT for panic reduction. The project aims to obtain initial effect sizes and perform an initial test of putative mechanisms of our specialized behavioral group protocol, Panic and Smoking Reduction Treatment (PSRT), combined with DCS as compared to PSRT plus placebo. The PSRT program integrates interceptive exposure, cognitive restructuring, and psycho education exercises with standard smoking cessation strategies and nicotine replacement therapy. Adult smokers (n = 80) with panic attacks will be recruited and randomly assigned to either: (1) PSRT plus DCS or (2) PSRT plus pill placebo. Primary outcome measures will be point prevalence abstinence, time to first smoking lapse, and time to smoking relapse, assessed at 2, 4, 8, 10, 16, and 24 weeks after quit date. Proposed mediators include panic attacks, distress intolerance, anxiety sensitivity, nicotine withdrawal symptoms, and negative effect. These variables will be assessed at baseline, weekly during the treatment phase, and at 2, 4, 8, 10, 16, and 24 weeks after quit date. The proposed study represents a crucial and important stage in translating basic research to strategies for treating nicotine dependence. The investigation addresses an important public health issue by testing an integrated intervention --- informed by basic research --- that may lead to a more effective and efficient treatment for at-risk smokers while simultaneously isolating explanatory mechanisms. The expected findings should: (1) guide advances in the theoretical conceptualization of the mechanisms involved in panic- and anxiety-smoking relations; and (2) provide initial effect size data for the addition of DCS to an integrated psychosocial/behavioral and pharmacological smoking cessation intervention for smokers with panic attacks, and thus provide the necessary data for a large-scale follow-up trial.

描述（由申请人提供）：美国大约有9-1500万吸烟者在其一生中符合至少一种焦虑症的标准（Kessler等，2005），这些人面临戒烟的重大挑战（Piper等，2010a; Zvolensky等，2008）。然而，很少关注焦虑症患者，尤其是有惊恐发作史的吸烟者维持烟草使用的关注。该小组对研究特别重要，因为研究表明，他们的戒烟率明显低于没有惊恐发作史的吸烟者，并且对安慰剂，单一停止和戒烟药物治疗的反应相同（Piper等，2010a）。当前研究的目的是试行测试D-Cycloserine（DCS）与PIL安慰剂的效力，以焦虑敏感性，困扰性的作用，对认知行为计划（CBT） 吸烟中的不宽容和惊恐发作。拟议的项目直接基于我们的基础和临床研究以及（a）烟草关系的相应试点工作； （b）针对恐慌和焦虑的吸烟者的密集认知行为干预（CBT）； （c）DCS增强CBT以减少恐慌。该项目旨在获得初始效果大小，并对我们专业行为组协议，恐慌和吸烟疗法（PSRT）的假定机制进行初步测试，与DC相比，与PSRT Plus Plus安慰剂相比。 PSRT计划与标准的戒烟策略和尼古丁替代疗法结合了截然暴露，认知重组和心理教育练习。成人吸烟者（n = 80）将被招募，并随机分配给：（1）PSRT加上DCS或（2）PSRT Plus Pill Pill安慰剂。主要结局指标将是戒烟的时间，首次吸烟的时间以及吸烟复发的时间，在退出日期后的2、4、8、10、16和24周评估。拟议的调解人包括惊恐发作，遇险不耐症，焦虑敏感性，尼古丁戒断症状和负面影响。这些变量将在基线，每周在治疗阶段以及退出日期后的2、4、8、10、16和24周进行评估。拟议的研究代表了将基础研究转化为治疗尼古丁依赖性策略的关键和重要阶段。该调查通过测试一项综合干预措施来解决一个重要的公共卫生问题 - 并由基础研究告知 - 这可能会导致对高危吸烟者的更有效和有效的治疗，同时隔离解释机制。预期的发现应：（1）指导在恐慌和焦虑关系中涉及的机制的理论概念化方面的进步； （2）提供初始效应大小数据，以使DC在恐慌发作的吸烟者中添加DC，以在吸烟者中添加DC，从而为大规模的随访试验提供必要的数据。