Center for Addiction Medicine

Smoking Cessation and Cessation Maintenance in Smokers with and without Severe Mental Illness (SMI) During Sustained Pharmacotherapy with Varenicline

This study is using a combined data set consisting of the data collected at MGH by Dr. Evins from a study population of smokers with SMI and a study with a comparable study design conducted at Pfizer in a population of smokers without SMI. The aim is to test the hypotheses that smokers without SMI will achieve a higher proportion of continuous tobacco abstinence during the maintenance of smoking cessation phase (i.e., in the 12 weeks post randomization, study weeks 12-24) than smokers with SMI, but this diagnosis effect will be normalized (i.e., will not be apparent) in the active pharmacotherapy (i.e., varenicline) group; smokers without SMI will have a longer mean time to relapse than smokers with SMI, and this difference will be greatest under placebo conditions and less pronounced in participants receiving active pharmacotherapy (varenicline) and that smokers without SMI will achieve a higher proportion of biochemically validated 7-day point prevalence tobacco abstinence during active, open-label treatment with varenicline than smokers with SMI, even after adjusting for baseline differences in age, gender, severity of nicotine dependence, cigarettes smoked per day, age of onset of daily smoking.