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 ofvarenicline 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.
RCT Entities:
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.
Authors: Douglas E Jorenby; J Taylor Hays; Nancy A Rigotti; Salomon Azoulay; Eric J Watsky; Kathryn E Williams; Clare B Billing; Jason Gong; Karen R Reeves Journal: JAMA Date: 2006-07-05 Impact factor: 56.272
Authors: Elaine Weiner; Alison Buchholz; Agnes Coffay; Fang Liu; Robert P McMahon; Robert W Buchanan; Deanna L Kelly Journal: Schizophr Res Date: 2011-03-04 Impact factor: 4.939
Authors: Michael J Ostacher; Richard T Lebeau; Roy H Perlis; Andrew A Nierenberg; Hannah G Lund; Samantha J Moshier; Gary S Sachs; Naomi M Simon Journal: Bipolar Disord Date: 2009-11 Impact factor: 6.744
Authors: John A Stapleton; Lucy Watson; Lucy I Spirling; Robert Smith; Andrea Milbrandt; Marina Ratcliffe; Gay Sutherland Journal: Addiction Date: 2007-11-19 Impact factor: 6.526
Authors: John R Hughes; Josue P Keely; Ray S Niaura; Deborah J Ossip-Klein; Robyn L Richmond; Gary E Swan Journal: Nicotine Tob Res Date: 2003-02 Impact factor: 4.244
Authors: Jennifer B McClure; Gary E Swan; Lisa Jack; Sheryl L Catz; Susan M Zbikowski; Tim A McAfee; Mona Deprey; Julie Richards; Harold Javitz Journal: J Gen Intern Med Date: 2009-02-24 Impact factor: 5.128
Authors: Faith B Dickerson; Christina L G Savage; Lucy A B Schweinfurth; Deborah R Medoff; Richard W Goldberg; Melanie Bennett; Alicia Lucksted; Matthew Chinman; Gail Daumit; Lisa Dixon; Carlo DiClemente Journal: Psychiatr Rehabil J Date: 2015-10-12
Authors: Randi M Schuster; Corinne Cather; Gladys N Pachas; Haiyue Zhang; Kristina M Cieslak; Susanne S Hoeppner; David Schoenfeld; A Eden Evins Journal: Addict Behav Date: 2017-02-24 Impact factor: 3.913
Authors: Shadi Nahvi; Bryan Wu; Kimber P Richter; Steven L Bernstein; Julia H Arnsten Journal: Drug Alcohol Depend Date: 2013-01-17 Impact factor: 4.492
Authors: Kristen M Mackowick; Mera S Barr; Victoria C Wing; Rachel A Rabin; Clairelaine Ouellet-Plamondon; Tony P George Journal: Prog Neuropsychopharmacol Biol Psychiatry Date: 2013-07-19 Impact factor: 5.067