Efficacy of the Cigarette-Burning application combined with medication intervention for smoking cessation in China: A Randomized Clinical Trial (Preprint)

Abstract

Although smartphone application (app) for smoking cessation was considered as a promising strategy, the results of studies about apps were inconsistent, and there were few studies on combinations of usual interventions and apps in smoking cessation.

To evaluate the efficacy of the Cigarette-Burning application combined with medication intervention for smoking cessation.

A parallel, open-label randomized clinical trial was conducted with a ratio of 1:1 allocation into the bupropion plus app group and bupropion group. All participants received bupropion intervention. Besides, participants in the bupropion plus app group were required to download and use the Cigarette-Burning app, which developed based on smoking cessation guidelines. Follow-up visits were conducted at weeks 1, 2, 4, 9, 12, and 24 after initiation of treatment.

400 participants were included in the intention-to-treat analysis from July 2019 to June 2021. The median (IQR) age was 48.0 (38.0-59.0) years, and 374(93.5%) were men. The continuous abstinence rate at 9-12 weeks was significantly higher in the bupropion plus app group (39.5%) than in the bupropion group (27.5%) (OR=1.64, 95%CI 1.04-2.60, P < 0.05). The similar result was found for 24-week sustained abstinence rate. The results of subgroup analysis expressed that the 9-12w continuous abstinence rate was significantly higher in the bupropion plus app group when smokers were at older age, higher education level, higher degree of tobacco dependence or younger age at starting smoking (P < 0.05).

This trial provides evidence that the Cigarette-Burning smartphone application significantly increased smoking abstinence when combined with medications and could be an accessible complement to smoking cessation support.

Chinese Clinical Trial Registry (No.: ChiCTR1800016919; http://www.chictr.org.cn).