A Randomised Controlled Trial of a Novel Digital Therapy for Smoking Cessation

Abstract

Background: Evidence-based digital therapies for smoking cessation that include a smartphone application (app), the efficacy of which is scientifically demonstrated, are limited. The present study sought to demonstrate the efficacy of a novel digital therapy, 'CureApp Smoking Cessation' (CASC), integrated with a mobile carbon monoxide (CO) checker. Methods: In this multi-centre randomised controlled trial (RCT), 584 participants with nicotine dependence were allocated 1:1 to CASC intervention or control groups by a computer-generated random sequence with stratification for smoking cessation medications and study sites. Both groups received a standard smoking cessation treatment with pharmacotherapy and counselling for 12 weeks. The intervention group used the CASC system, and the control group used a control-app without a mobile CO checker, both for 24 weeks. The primary outcome was the biochemically validated continuous abstinence rate (CAR) from weeks 9-24. Main secondary outcome was an extended CAR from weeks 9-52. Findings: Except for 12 participants who did not download or use the apps, 285 participants were assigned to the intervention group, and 287, to the control group. CAR from weeks 9-24 in the intervention group was significantly higher than that in the control group (63·9% vs 50·5%; odds ratio [OR], 1·73; 95% confidence interval [CI], 1·24 to 2·42; p=0·001). CAR from weeks 9-52 also was higher in the intervention group than that in the control group (52·3% vs 41·5%; OR, 1·64; 95% CI, 1·16 to 2·32; p=0·005). No specific adverse events caused by the CASC system were reported. Interpretation: Despite the restricted areas and ages in Japan, in which smartphone usage rates were high, this study was the first large RCT with a smartphone-based digital therapy for smoking cessation with a long-term observation period. Augmenting the standard treatment with pharmacotherapy, the digital therapy, the CASC system, significantly improved long-term CARs. Funding Statement: CureApp, Inc. Declaration of Interests: KM, HT, and KF have received honoraria from CureApp, Inc. AN received consulting fees from CureApp, Inc. AN and KS are founders of the CureApp Institute. TM is an employee of CureApp, Inc. KS and SS are founders and shareholders of CureApp, Inc. and patent holders of the CASC. EH has a consultation contract as a biostatistician with CureApp, Inc. Ethics Approval Statement: The study was performed in compliance with CONSORT statements. The protocol and informed consent forms were reviewed and approved by the Institutional Review Board at Keio University School of Medicine and all affiliated institutions.