E-Cigarette Provision to Promote Switching in Cigarette Smokers With Serious Mental Illness—A Randomized Trial

Abstract Background High cigarette smoking prevalence and low quit rates in people with serious mental illness (SMI) contribute to disparate rates of chronic disease and premature death. This prospective trial tested the impact of switching to a potentially lower-harm nicotine-containing product on smoking in this population. Aims and Methods A total of 240 cigarette smokers with SMI who tried but were currently unwilling to quit were randomly assigned to receive disposable e-cigarettes for 8 weeks or not, with assessments at baseline, 2, 4, 6, 8, 13, and 26 weeks. Generalized linear mixed models examined the effects of e-cigarette provision on e-cigarette appeal, cigarettes per day (CPD), breath carbon monoxide (CO), nicotine dependence, and side effects. Clinical Trial registration: NCT03050853. Results Self-reported smoking was similar between groups at baseline (mean = 18.7 CPD). By week 2, 79% of the e-cigarette group were using e-cigarettes daily. During weeks 2–8, CPD and CO decreased in the e-cigarette versus assessment-only group (eg, 7.5 CPD [95% CI = 5.9, 9.2] vs. 18.1 CPD [CI = 16.4, 19.8] and 16.4 ppm [CI = 13.4, 19.5] vs. 25.4 ppm [CI = 22.4, 28.9], respectively, at week 2). Additionally, 19%–22% in the e-cigarette group reported smoking no cigarettes in weeks 2–8 compared to 0% in the assessment-only group. By 13 and 26 weeks, group differences in CPD, but not CO, remained significant. Nicotine dependence did not increase and side effects were minor. Conclusions Providing e-cigarettes for 8 weeks to smokers with SMI resulted in substantial reductions in CPD and CO. Enhancing and maintaining switching from cigarettes to e-cigarettes warrant further study. Implications This was the first prospective study to compare e-cigarette provision with assessments only to evaluate the appeal and impact of e-cigarettes on smoking behavior, carbon monoxide exposure, and nicotine dependence among smokers with SMI who had tried but were unable to quit and were not currently interested in cessation treatment. The finding that e-cigarette provision led to significant reductions in smoking and carbon monoxide without increasing nicotine dependence has implications for reducing harm not only among the millions of smokers with SMI who struggle to quit, but also for other vulnerable smokers who cannot achieve cessation.