This proposal focuses on providing the candidate with the expertise needed to bridge several disciplines in the study of pharmacologic and behavioral interventions in the treatment of nicotine addiction in schizophrenia. Nearly 90 percent of patients with schizophrenia smoke cigarettes compared to less than 25 percent of the general U.S. adult population. Compounded by the problem that patients with schizophrenia are less likely to receive adequate routine and preventative medical care, heavy smoking represents a significant and neglected public health problem for people with schizophrenia. In pilot trials, the candidate found bupropion SR to be safe and effective for smoking reduction and cessation in patients with schizophrenia while improving negative and depressive symptoms and preventing weight gain and exacerbation of psychosis. In the proposed study, 60 subjects with schizophrenia who smoke greater than 10 cigarettes per day and wish to quit smoking will be randomized, in double blind fashion, to receive either bupropion SR or placebo for twelve weeks, combined with a nine week cognitive behavioral Quit Smoking Group Therapy Program modified by the candidate for patients with schizophrenia. The primary outcome measure is 7-day point prevalence of greater than or equal to 50 percent smoking reduction at the end of 12 weeks treatment that is biochemically confirmed. Secondary outcome measures are 7-day point prevalence tobacco abstinence at the end of the 3 month treatment and 3 month follow up phases, sustained tobacco abstinence or reduction, change in psychiatric symptoms, cognitive functioning, weight, side effects and health related quality of life. Career Development Plan: The candidate will build upon her experience conducting treatment trials for negative symptoms of schizophrenia. With consultation from individuals with the appropriate expertise, the candidate will design, implement and interpret pharmacologic intervention trials for smoking cessation in schizophrenia, study of cognitive behavioral therapy interventions in patients with the dual diagnoses of addiction and major mental illness, study of harm reduction strategies in patients with schizophrenia unable to attain abstinence, and studies of the effect of nicotinic agents on attention and memory in schizophrenia that will lay the foundation for future independent investigation by the candidate in these areas. The mentored investigative work will take place at the Massachusetts General Hospital and will complement an intensive training program of coursework at the Massachusetts General Hospital and the Harvard School of Public Health on methodology, epidemiology, statistics, and responsible conduct of research.
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