Tatiana Gomez Gomez, MD
Dr. Phillip Frost Department of dermatology & cutaneous surgery, University of Miami, Miami, FL, USA.
Inia Andrea Perez Villa, MD
Infectious Disease Unit, Internal Medicine Department, Clinica Alemana de Santiago, Chile
Oluwatosin Zainab Omoyiola, MBChB,FMCPath
Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife, Nigeria
Gabriela Harumi Harano, Bpharm
Kaytiussia Raulino de Sena
Harvard T.H Chan School of Public Health ECPE – PPCR, Boston, MA, USA.
Deusdedit Brandão Neto, MD
Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
Alexandra Maria Rojas Amaris, MD
Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
Fernando Andres Terry Escalante, MD
Universidad de San Martín de Porres, Facultad de Medicina Humana, Lima, Perú. REDECS Red de Eficacia clínica y Sanitaria. Lima, Perú
Yasmin Chimoni Pinto, Bpharm
Geraldine Olivia M. Martens, PT, P.hD.
Physical Medicine and Rehabilitation Departement, University Hospital of Liège, Belgium
Rene Efrain Flores Cardenas, MD
Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts
Cesar Augusto Rangel Junior, MD
Naomi Vidal Ferreira, P.hD.
Adventist University of Sao Paulo, Engenheiro Coelho, SP, Brazil/Departamento de Ciências Médicas. Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil
Javier Ardebol Cook, MD
Medical Research, Facultad de Medicina, Universidad Francisco Marroquín, Guatemala City, Guatemala
Fleming Mathew, MBBS
Sharda Hospital and School of Medical Sciences and Research, Sharda University, Greater Noida, Uttar Pradesh, India
Daniel Menezes de Oliveira Lima, MD
Universidade Salvador(UNIFACS), Salvador, Brazil.
Javed Iqbal, BS Nursing, MHA
Hamad Medical Corporation, Doha Qatar
Geethiikha Jammula, MBBS
Guntur Medical College, DR. N.T.R University Of Health Sciences, Guntur, Andhra Pradesh, India
Barbara da Camara Santos Marinho, MBBS
Faculty of Medicine, Universidade Potiguar, Natal, Brazil.
Thiago Ramos Grigio, MD, MSc
Teaching Assistant, Harvard T.H Chan School of Public Health ECPE – PPCR, Boston, MA, USA. Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
Vinicius Caldeira Quintao, MD MSc
Teaching Assistant, Harvard T.H Chan School of Public Health ECPE – PPCR, Boston, MA, USA. Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
Carla Graziella Queiroga de Souza, B.Sc.
Teaching Assistant, Harvard T.H Chan School of Public Health ECPE – PPCR, Boston, MA, USA.
Maria Cecília de Carvalho Bortoletto, MD
Teaching Assistant, Harvard T.H Chan School of Public Health ECPE – PPCR, Boston, MA, USA.
Rui Nakamur, MD
Teaching Assistant, Harvard T.H Chan School of Public Health ECPE – PPCR, Boston, MA, USA.
Abstract
Abstract:
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.
