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Med."],"abstract":"<jats:title>Abstract<\/jats:title><jats:p>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 \u201cCureApp Smoking Cessation (CASC)\u201d 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\u2009in 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;<jats:italic>P<\/jats:italic>\u2009=\u20090.001). 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;<jats:italic>P<\/jats:italic>\u2009=\u20090.010). 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.<\/jats:p>","DOI":"10.1038\/s41746-020-0243-5","type":"journal-article","created":{"date-parts":[[2020,3,12]],"date-time":"2020-03-12T11:02:39Z","timestamp":1584010959000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":96,"title":["A randomized controlled trial of a smoking cessation smartphone application with a carbon monoxide checker"],"prefix":"10.1038","volume":"3","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0909-9409","authenticated-orcid":false,"given":"Katsunori","family":"Masaki","sequence":"first","affiliation":[]},{"given":"Hiroki","family":"Tateno","sequence":"additional","affiliation":[]},{"given":"Akihiro","family":"Nomura","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3427-458X","authenticated-orcid":false,"given":"Tomoyasu","family":"Muto","sequence":"additional","affiliation":[]},{"given":"Shin","family":"Suzuki","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1035-4481","authenticated-orcid":false,"given":"Kohta","family":"Satake","sequence":"additional","affiliation":[]},{"given":"Eisuke","family":"Hida","sequence":"additional","affiliation":[]},{"given":"Koichi","family":"Fukunaga","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2020,3,12]]},"reference":[{"key":"243_CR1","doi-asserted-by":"publisher","first-page":"2287","DOI":"10.1016\/S0140-6736(15)00128-2","volume":"386","author":"MH Forouzanfar","year":"2015","unstructured":"Forouzanfar, M. 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A.N. received consulting fees from CureApp, Inc. A.N. and K.S. are founders of the CureApp Institute. T.M. is an employee of CureApp, Inc. K.S. and S.S. are founders and shareholders of CureApp, Inc. and patent holders of the CASC. E.H. has a consultation contract as a biostatistician with CureApp, Inc.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing Interests"}}],"article-number":"35"}}