OBJECTIVES:
Varenicline was approved by the FDA in 2006. In 2009, based largely on case reports, the FDA issued a warning of possible adverse neuropsychiatric effects including depression and suicidal thoughts and behavior for
varenicline and
bupropion. Prospective trials of
varenicline have not reported increased incidence of psychiatric adverse events other than sleep disturbance, but smokers with major
mental illness have been excluded from large prospective trials of
varenicline to date. We sought to evaluate the effect of a standard open-label 12-week
varenicline trial on prospectively assessed safety and smoking outcomes in stable, treated adults with
schizophrenia spectrum disorder and
nicotine dependence. METHODS: One-hundred-and-twelve stable outpatients who smoked >10 cigarettes/day participated in a 12-week, open-label, smoking cessation trial of
varenicline and weekly group cognitive behavioral therapy. Participants took
varenicline for 4 weeks before attempting cessation. Trained raters collected safety and smoking outcome data weekly. RESULTS: Participants demonstrated improved psychotic symptoms, depressive symptoms and
nicotine withdrawal symptoms from baseline to week 12 or early termination. At the end of 12 weeks open label treatment, the 14- and 28-day continuous abstinence rates were 47.3 and 34%, respectively. Expired CO declined significantly during treatment in those who did not achieve abstinence. CONCLUSIONS: This prospective study suggests that
varenicline may be well-tolerated and effective for smoking cessation in combination with group CBT in stable outpatients with
schizophrenia, a group with high rates of smoking and smoking-attributable morbidity and mortality.