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）：美国约有900万至1500万吸烟者在其一生中符合至少一种焦虑症的标准（Kessler等人，2005）并且这些人经历戒烟的重大挑战（Piper等人，2010 a; Zvolensky等人，2008年）。然而，很少有人关注焦虑症患者，特别是有惊恐发作史的吸烟者的烟草使用。这一组对于研究特别重要，因为研究表明，他们的戒烟率显著低于没有惊恐发作史的吸烟者，并且他们对安慰剂、单一戒烟和联合戒烟药物治疗的反应相同（Piper et al.，2010年a）。目前研究的目的是初步测试在认知行为计划（CBT）中添加d-环丝氨酸（DCS）与安慰剂相比的疗效，该计划针对焦虑敏感性、痛苦和抑郁的作用。 不耐受和维持吸烟时的恐慌症。拟议的项目直接建立在我们的基础和临床研究以及相应的试点工作（a）烟草恐慌关系;（B）针对恐慌和焦虑倾向吸烟者的强化认知行为干预（CBT）;（c）DCS增强CBT以减少恐慌。该项目旨在获得初始效应量，并对我们的专业行为组方案（恐慌和吸烟减少治疗（PSRT））与DCS相结合与PSRT+安慰剂相比的推定机制进行初步测试。PSRT计划将拦截暴露、认知重建和心理教育练习与标准戒烟策略和尼古丁替代疗法相结合。将招募患有惊恐发作的成年吸烟者（n = 80），并随机分配至：（1）PSRT + DCS或（2）PSRT+药丸安慰剂组。主要结局指标将是戒烟率、首次戒烟时间和复吸时间，分别在戒烟后2、4、8、10、16和24周进行评估。建议的介质包括恐慌发作，痛苦不耐受，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、治疗期每周以及戒烟后2、4、8、10、16和24周进行评估。这项拟议的研究代表了将基础研究转化为治疗尼古丁依赖策略的关键和重要阶段。这项调查通过测试一种综合干预措施解决了一个重要的公共卫生问题-以基础研究为依据-这可能会导致对高危吸烟者更有效和更高效的治疗，同时隔离解释机制。预期的调查结果应：（1）指导恐慌和焦虑与吸烟关系机制的理论概念化的进展;（2）为将DCS添加到恐慌发作吸烟者的综合心理/行为和药物戒烟干预中提供初始效应量数据，从而为大规模随访试验提供必要的数据。