Targeted Intervention for Bipolar Smokers

描述（由申请人提供）：迄今为止，将双相情感障碍患者排除在戒烟治疗研究之外令人不安，因为该组的吸烟率大约是普通人群的两倍，并且目前双相吸烟者治疗方法的疗效和安全性基本上是未知的。这个K23指导的以患者为导向的研究职业发展奖提案要求为Jaimee Heffner博士提供为期5年的支持，以完成一项针对双相情感障碍患者的药物和行为戒烟干预相结合的培训和研究计划。拟议的职业发展活动将促进Heffner博士的长期职业目标，即为精神疾病患者确定有效的戒烟干预措施，重点是双相情感障碍和物质使用障碍。Robert Anthenelli博士和Stephen Strakowski博士分别是申请人的共同导师和戒烟和双相情感障碍治疗领域的既定研究人员，他们将监督申请人职业发展目标的完成。辛辛那提大学医学院将提供强大的基础设施，以完成该奖项的培训和研究计划。拟议的研究计划包括开发和试点测试一种新的行为戒烟干预，双相吸烟者的有针对性的干预（TIBS）。TIBS将分两个阶段进行开发和试点测试，与行为治疗研究阶段模型的阶段Ia和阶段Ib一致（Rounsaville，卡罗尔和Onken，2001）。第一阶段将涉及制定治疗手册，治疗完整性措施，治疗师培训材料，以及预试点测试（n=10）。第二阶段将是一项为期12周的初步试验，其中所有参与者将随机接受TIBS（n=20）或与接触时间相等的对照治疗（n=20）。所有参与者将接受8周的开放标签经皮尼古丁替代疗法。这项研究的结果将为R01申请奠定基础，以资助更大规模的疗效试验，并促进对精神症状与吸烟之间复杂关系的理解。 公共卫生相关性： 患有精神疾病的人吸烟几乎占美国销售的香烟的一半，并且比没有精神疾病的人早死30年。该奖项将使申请人能够为双相情感障碍患者开发戒烟研究方面的专业知识，这是一个严重缺乏服务的群体，吸烟率高，戒烟成功率低。

DESCRIPTION (provided by applicant): The exclusion of individuals with bipolar disorder from smoking cessation treatment research to date is disconcerting, as the prevalence of smoking in this group is roughly double that of the general population and the efficacy and safety of current treatment approaches for bipolar smokers is essentially unknown. This K23 Mentored Patient-Oriented Research Career Development Award proposal requests a 5-year period of support for Dr. Jaimee Heffner to complete a focused program of training and research involving combined pharmacological and behavioral smoking cessation interventions for individuals with bipolar disorder. The proposed career development activities will facilitate Dr. Heffner's long-term career goal of identifying efficacious smoking cessation interventions for individuals with psychiatric disorders, with an emphasis on bipolar disorders and substance use disorders. Dr. Robert Anthenelli and Dr. Stephen Strakowski, the applicant's co-mentors and established investigators in the areas of smoking cessation and bipolar disorder treatment, respectively, will oversee completion of the applicant's career development goals. The University of Cincinnati College of Medicine will provide a strong infrastructure to complete both the training and research plans of the award. The proposed research plan includes developing and pilot testing a novel behavioral smoking cessation intervention, the Targeted Intervention for Bipolar Smokers (TIBS). TIBS will be developed and pilot-tested in two phases, consistent with Stage Ia and Stage Ib of the Stage Model of Behavioral Therapies research (Rounsaville, Carroll, & Onken, 2001). The first phase will involve developing a treatment manual, treatment integrity measures, and therapist training materials, as well as pre-pilot testing (n=10). The second phase will be a 12-week pilot trial in which all participants will be randomized to receive either TIBS (n=20) or a control treatment equated for contact time (n=20). All participants will receive 8 weeks of open- label transdermal nicotine replacement therapy. The results of this research will lay the groundwork for an R01 application to fund a larger-scale efficacy trial as well as advancing understanding of the complex relationship between psychiatric symptoms and smoking. PUBLIC HEALTH RELEVANCE: Individuals with psychiatric disorders smoke almost half of the cigarettes sold in the U.S. and die up to three decades earlier than individuals who do not have psychiatric disorders. This award will allow the applicant to develop expertise in smoking cessation research for individuals with bipolar disorder, a critically underserved group with a high prevalence of smoking and low rate of successful quitting.