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.
J aim ee 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.
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.
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