Effectiveness of an mHealth App as an add-on for Smoking Cessation in One year: A multicenter and randomized Trial (The MASCOT study)

Main Article Content

Tatiana Gomez Gomez, MD
Inia Andrea Perez Villa, MD
Oluwatosin Zainab Omoyiola, MBChB,FMCPath
Gabriela Harumi Harano, Bpharm
Kaytiussia Raulino de Sena
Deusdedit Brandão Neto, MD
Alexandra Maria Rojas Amaris, MD
Fernando Andres Terry Escalante, MD
Yasmin Chimoni Pinto, Bpharm
Geraldine Olivia M. Martens, PT, P.hD.
Rene Efrain Flores Cardenas, MD
Cesar Augusto Rangel Junior, MD
Naomi Vidal Ferreira, P.hD.
Javier Ardebol Cook, MD
Fleming Mathew, MBBS
Daniel Menezes de Oliveira Lima, MD
Javed Iqbal, BS Nursing, MHA
Geethiikha Jammula, MBBS
Barbara da Camara Santos Marinho, MBBS
Thiago Ramos Grigio, MD, MSc
Vinicius Caldeira Quintao, MD MSc
Carla Graziella Queiroga de Souza, B.Sc.
Maria Cecília de Carvalho Bortoletto, MD
Rui Nakamur, MD



Introduction: Smoking accounts for 480,000 deaths per year in the United States. Traditional pharmacotherapeutic interventions for smoking cessation continue to fail, urging the implementation of new therapies to prevent further harm. Mobile Health apps have appeared to support smoking cessation; their low cost, wide availability, absence of side effects, and drug-to-drug interaction make them useful adjuncts in some populations. Despite promising results, only a small number of smoking cessation apps have been formally researched as an add-on therapy. Therefore, we hypothesize that using a mobile health app (PIVOT) as an add-on to the current standard therapy (varenicline plus cognitive-behavioral therapy) could increase the smoking cessation rate.

Methods: We propose a Phase III, multicenter, randomized, parallel-group, open-label, superiority trial. The control group will receive varenicline 1mg/daily for 3 months plus 10 sessions of cognitive-behavioral therapies. The intervention group will receive the same treatment plus the addition of the PIVOT® app for one year. Participants will be 21 to 60 years old who meet the Tobacco Use Disorder criteria. The primary outcome will be smoking abstinence at 1 year of follow-up. Secondary outcomes will be lapses and relapses, cotinine hair drug testing at the end of follow-up, and the impact on Quality of Life measured through the WHO Quality of Life Scale-Brief questionnaire. 

Discussion: mobile Health Apps are widely available and extensively used by smokers to aid smoking cessation; however, their effectiveness as an add-on is unproven. This study will provide evidence on this matter to advise future clinical practice guidelines and decrease the morbidity and mortality attributable to tobacco use.

Article Details

How to Cite
Gomez Gomez, T., Perez Villa, I. A. ., Zainab Omoyiola, O. ., Harumi Harano, G. ., Raulino de Sena , K., Neto, D. B., Rojas Amaris, A. M., Terry Escalante, F. A. ., Chimoni Pinto, Y., Martens, G. O. M. ., Flores Cardenas, R. E., Rangel Junior, C. A., Vidal Ferreira, N., Ardebol Cook, J., Mathew, F., Menezes de Oliveira Lima, D., Iqbal, J., Jammula, G., da Camara Santos Marinho, B. ., Ramos Grigio, T., Caldeira Quintao, V., Queiroga de Souza, C. G., de Carvalho Bortoletto, M. C., & Nakamur, R. . (2022). Effectiveness of an mHealth App as an add-on for Smoking Cessation in One year: A multicenter and randomized Trial (The MASCOT study). Principles and Practice of Clinical Research, 8(3), 60–67. https://doi.org/10.21801/ppcrj.2022.83.6
Clinical Research Design

Most read articles by the same author(s)