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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.