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| |  Varenicline for Smoking Cessation May Be Safe and Effective in Patients With Schizophrenia: Presented at SRNT By Liz Meszaros BALTIMORE, Md -- March 2, 2010 -- Preliminary data from a 12-week trial suggest that treatment with varenicline for smoking cessation may not cause a worsening of symptoms of depression, psychosis, or cognitive function in patients with schizophrenia, according to research presented here at the 2010 Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting. “These data suggest that varenicline is safe for use in stable outpatient smokers with schizophrenia,” said A. Eden Evins, MD, MPH, Harvard Medical School, Boston, Massachusetts, on February 28. “There is preliminary evidence that varenicline, used in the setting of a smoking cessation attempt, is associated with improved verbal memory and speed of psychomotor processing.” Three years after the approval of varenicline in 2006, the US Food and Drug Administration issued a warning cautioning users against the adverse behavioural and psychiatric effects of varenicline, including depressed mood, suicidal ideation and attempts, agitation, and loss of behavioural control. Smokers with schizophrenia may be a high-risk group for these adverse effects because of underlying psychiatric vulnerability. The researchers undertook this study to evaluate the effects of varenicline on psychiatric symptoms and cognitive performance in stable outpatient smokers with schizophrenia who are attempting to quit smoking. They included 98 subjects from May 2008 through December 2009 for this 12-week, open label smoking cessation trial. All subjects were on stable antipsychotic medications, smoked >=10 cigarettes per day, and had not been hospitalised for suicidal ideation in the past 12 months. Subjects who quit smoking in the open phase were enrolled in a 40-week, double-blind, placebo-controlled, relapse-prevention phase. Of the 98 subjects, 43% achieved biochemically verified continuous abstinence from tobacco of 2 weeks or greater by the end of the 12-week open varenicline treatment period. Structured clinical ratings of psychiatric symptoms or cognitive performance did not worsen in the study group as a whole. In these patients, Brief Psychiatric Rating Scale psychosis subscale improved (10.4 [5.6], 9.6 [5.0]; P < .04). Patients discontinued treatment because of nausea (n = 5), depressed mood (n = 2), dysphoria (n = 1), substance use and increased psychotic symptoms (n = 1), and anxiety (n = 1). Dr. Evins said, “These results indicate that varenicline is effective for smoking cessation in those with schizophrenia and that varenicline can be used safely in those with schizophrenia. In our study, participants were followed weekly for safety. This level of clinical follow-up is advised.” This study was funded by a grant from the National Institutes of Health. [Presentation title: Safety and Efficacy of Varenicline in Schizophrenia: Preliminary Data From 12-Week Trial. Abstract POS5-117]
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