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.
- Smoking cessation
- Tobacco Use Disorder
- mHealth App
- Cognitive-behavioral therapy (CBT)