Efficacy and safety of esketamine for smoking cessation among patients diagnosed with lung cancer and major depression disorder: A randomized, placebo-controlled clinical trial.

This multicenter, randomized, placebo-controlled, clinical trial was designed to investigate the efficacy and safety of esketamine (ESK) for smoking cessation. The study enrolled a sample of 236 patients diagnosed with lung cancer and major depression disorder (MDD). Treatment included intranasal delivery of ESK or placebo once a week for 8 sessions. The primary outcomes were self-reported and biologically verified continuous abstinence rates at the end of 6 months follow-up visit. The second outcomes were the severity changes of depression and anxiety. The cognitive function, the nicotine dependence, urge to smoke, respiratory symptoms and adverse events were also examined. We found that 8 sessions of ESK treatments significantly improved the self-reported (44.1 %) and biologically verified (28.8 %) continuous abstinence rates. Additionally, the severity of both depression and anxiety was also significantly relieved by ESK delivery. Furthermore, ESK was capable of improving cognitive function of the participants. Finally, the nicotine dependence, urge to smoke and smoking related respiratory symptoms of ESK group were also alleviated at the completion of follow-up. No serious adverse events were observed throughout the study. This clinical trial provides evidence that ESK treatment is efficacious and safe for quitting cigarette smoking among patients with lung cancer and MDD.