Evidence of the long-term efficacy of digital therapies for smoking cessation that include a smartphone application (app) is limited. In this multi-center randomized controlled trial, we tested the efficacy of a novel digital therapy for smoking cessation: the "CureApp Smoking Cessation (CASC)" system, including a CASC smartphone app, a web-based patient management PC software for primary physicians, and a mobile exhaled carbon monoxide (CO) checker. A total of 584 participants with nicotine dependence were recruited from October 2017 to January 2018, and allocated 1:1 to the CASC intervention group or the control group. Both groups received a standard smoking cessation treatment with pharmacotherapy and counseling for 12 weeks. Meanwhile, the intervention group used the CASC system, and the control group used a control-app without a mobile CO checker, each for 24 weeks. The primary outcome was the biochemically validated continuous abstinence rate (CAR) from weeks 9 to 24. The main secondary outcome was an extended CAR from weeks 9 to 52. 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. CAR from weeks 9 to 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). The CAR from weeks 9 to 52 was also higher in the intervention group than that in the control group (52.3% vs. 41.5%; OR, 1.55; 95% CI, 1.11 to 2.16; P = 0.010). No specific adverse events caused by the CASC system were reported. Augmenting standard face-to-face counseling and pharmacotherapy with a novel smartphone app, the CASC system significantly improved long-term CARs compared to standard treatment and a minimally supportive control app.

Background Tobacco is a major public health concern. A 12-week standard smoking cessation program is available in Japan; however, it requires face-to-face clinic visits, which has been one of the key obstacles to completing the program, leading to a low smoking cessation success rate. Telemedicine using internet-based video counseling instead of regular clinic visits could address this obstacle. Objective This study aimed to evaluate the efficacy and feasibility of an internet-based remote smoking cessation support program compared with the standard face-to-face clinical visit program among patients with nicotine dependence. Methods This study was a randomized, controlled, open-label, multicenter, noninferiority trial. We recruited nicotine-dependent adults from March to June 2018. Participants randomized to the telemedicine arm received internet-based video counseling, whereas control participants received standard face-to-face clinic visits at each time point in the smoking cessation program. Both arms received a CureApp Smoking Cessation smartphone app with a mobile exhaled carbon monoxide checker. The primary outcome was a continuous abstinence rate (CAR) from weeks 9 to 12. Full analysis set was used for data analysis. Results We randomized 115 participants with nicotine dependence: 58 were allocated to the telemedicine (internet-based video counseling) arm and 57, to the control (standard face-to-face clinical visit) arm. We analyzed all 115 participants for the primary outcome. Both telemedicine and control groups had similar CARs from weeks 9 to 12 (81.0% vs 78.9%; absolute difference, 2.1%; 95% CI –12.8 to 17.0), and the lower limit of the difference between groups (–12.8%) was greater than the prespecified limit (–15%). Conclusions The application of telemedicine using internet-based video counseling as a smoking cessation program had a similar CAR from weeks 9 to 12 as that of the standard face-to-face clinical visit program. The efficacy of the telemedicine-based smoking cessation program was not inferior to that of the standard visit–based smoking cessation program. Trial Registration University Hospital Medical Information Network Clinical Trials Registry: UMIN000031620; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035975.

Background Smoking cessation treatment programs have been widely available for patients with nicotine dependence. Despite intensive programs, the continuous abstinence rate (CAR) from weeks 9-12 is still about 50%. Recently, a smartphone app emerged as a novel tool for therapeutic interventions, including nicotine dependence. In this study, we developed “CureApp Smoking Cessation” (CASC), which consists of a smartphone app for patients and a Web-based patient management software for doctors with a mobile carbon monoxide (CO) checking device to improve the efficacy of the smoking cessation treatment. Objective This study aims to evaluate whether the CASC app is effective for individuals with nicotine dependence in addition to standard smoking cessation programs. Methods This will be a randomized, sham-controlled, open-label, multicenter trial. We will recruit participants with nicotine dependence, but are otherwise healthy adults. We will randomize and allocate participants 1:1 to the CASC treatment group or a control app group. Both groups will receive a 12-week standard smoking cessation program with pharmacotherapy and counseling. In addition, participants in the treatment group will have the CASC app installed on their smartphone, which will provide video tutorials, advice from an artificial intelligence nurse, a digital diary, and measure daily exhaled CO concentration. In contrast, the control group will have the control app installed on their smartphone, where all the functions that can potentially effect smoking cessation are removed. The primary outcome will be the biochemically validated CAR from weeks 9-24. The success of smoking cessation will be defined as self-reported continuous abstinence from weeks 9-24 and exhaled CO concentration ≤10 ppm both at weeks 12 and 24. The main secondary outcomes will be the CAR from weeks 9-12, weeks 9-52, and 7-day point prevalence abstinence at weeks 4, 8, 12, 24, and 52. Results We will recruit 580 participants with nicotine dependence from October 2017 to September 2018 or until the recruitment process is complete. The final 52-week follow-up will be completed in October 2019. We expect all trial results to be available by the end of 2019. The trial is funded by CureApp, Inc. Conclusions This is the first randomized controlled trial to evaluate the efficacy of CASC. We expect that CASC, in addition to standard smoking cessation programs, has a significantly higher CAR during weeks 9-24 than the control app. Trial Registration University Hospital Medical Information Network Clinical Trials Registry UMIN000031589; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000033555 International Registered Report Identifier (IRRID) DERR1-10.2196/12252

BACKGROUND Smoking is a major public health concern. In Japan, a 12-week standard smoking cessation support program is available, however, its required face-to-face visits are a key obstacle in completing the program. Telemedicine is a useful way to provide medical treatment at a distance. Although telemedicine for smoking cessation using an internet-based video system has the potential for ensuring better clinical outcomes for patients with nicotine dependence, its efficacy is unclear. OBJECTIVE The aim of this study is to determine the efficacy and feasibility of a smoking cessation support program using an internet-based video system compared with a face-to-face program among patients with nicotine dependence. METHODS This study will be a randomized, controlled, open-label, multicenter trial. Participants randomized to the intervention arm will undergo an internet-based smoking cessation program, whereas control participants will undergo a standard face-to-face program. We will use the CureApp Smoking Cessation (CASC) for both arms, which consists of the CASC smartphone app for patients and a Web-based patient information management system for clinicians with a mobile carbon monoxide checking device. The primary endpoint will be the continuous abstinence rate (CAR) from weeks 9 to 12. Secondary endpoints will be: (1) the smoking cessation success rate at 4, 8, 12, and 24 weeks; (2) CAR from weeks 9 to 24; (3) changes in scores on the mood and physical symptoms scale and 12-Item French Version Of The Tobacco Craving Questionnaire; (4) Kano Test for Social Nicotine Dependence scores at 8, 12, and 24 weeks; (5) time to first lapse after the first visit; (6) nicotine dependence and cognition scale scores at 12 and 24 weeks; (7) usage rate of the CASC; (8) qualitative questionnaire about the usability and acceptability of telemedicine; and (9) presence of product problems or adverse events. RESULTS We will recruit 114 participants who are nicotine-dependent but otherwise healthy adults from March to July 2018 and follow up with them until January 2019 (24 weeks). We expect all study results to be available by the end of March 2019. CONCLUSIONS This will be the first randomized controlled trial to evaluate the efficacy and feasibility of an internet-based (telemedicine) smoking cessation support program relative to a face-to-face program among patients with nicotine dependence. We expect that the efficacy of the telemedicine smoking cessation support program will not be clinically worse than the face-to-face program. If this trial demonstrates that telemedicine does not have clinically worse efficacy and feasibility than a conventional face-to-face program, physicians can begin to offer a more flexible smoking cessation program to patients who may otherwise give up on trying such programs. CLINICALTRIAL University Hospital Medical Information Network Clinical Trials Registry: UMIN000031620; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035975 INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12701

Background Smoking is a major public health concern. In Japan, a 12-week standard smoking cessation support program is available, however, its required face-to-face visits are a key obstacle in completing the program. Telemedicine is a useful way to provide medical treatment at a distance. Although telemedicine for smoking cessation using an internet-based video system has the potential for ensuring better clinical outcomes for patients with nicotine dependence, its efficacy is unclear. Objective The aim of this study is to determine the efficacy and feasibility of a smoking cessation support program using an internet-based video system compared with a face-to-face program among patients with nicotine dependence. Methods This study will be a randomized, controlled, open-label, multicenter trial. Participants randomized to the intervention arm will undergo an internet-based smoking cessation program, whereas control participants will undergo a standard face-to-face program. We will use the CureApp Smoking Cessation (CASC) for both arms, which consists of the CASC smartphone app for patients and a Web-based patient information management system for clinicians with a mobile carbon monoxide checking device. The primary endpoint will be the continuous abstinence rate (CAR) from weeks 9 to 12. Secondary endpoints will be: (1) the smoking cessation success rate at 4, 8, 12, and 24 weeks; (2) CAR from weeks 9 to 24; (3) changes in scores on the mood and physical symptoms scale and 12-Item French Version Of The Tobacco Craving Questionnaire; (4) Kano Test for Social Nicotine Dependence scores at 8, 12, and 24 weeks; (5) time to first lapse after the first visit; (6) nicotine dependence and cognition scale scores at 12 and 24 weeks; (7) usage rate of the CASC; (8) qualitative questionnaire about the usability and acceptability of telemedicine; and (9) presence of product problems or adverse events. Results We will recruit 114 participants who are nicotine-dependent but otherwise healthy adults from March to July 2018 and follow up with them until January 2019 (24 weeks). We expect all study results to be available by the end of March 2019. Conclusions This will be the first randomized controlled trial to evaluate the efficacy and feasibility of an internet-based (telemedicine) smoking cessation support program relative to a face-to-face program among patients with nicotine dependence. We expect that the efficacy of the telemedicine smoking cessation support program will not be clinically worse than the face-to-face program. If this trial demonstrates that telemedicine does not have clinically worse efficacy and feasibility than a conventional face-to-face program, physicians can begin to offer a more flexible smoking cessation program to patients who may otherwise give up on trying such programs. Trial Registration University Hospital Med...