Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Benefits of Tobacco Free Cigarette Among Heavy Smokers Undergoing a Lung Cancer Screening Program: a Randomized Controlled Study
Brief Summary: Background. Smoking is considered a global public health problem. For this reason, the smoking dependence was called by experts as a global epidemic.

Over the past three years, this electronic devices (Tobacco Free Cigarettes, or TFC) has been an important expansion in many countries. Nevertheless, there is poor evidence that TFC are beneficial for smoking cessation. In particular, even though it has been proved that the nicotine replacement devices helps many individuals to give up smoking and to tolerate the withdrawal symptoms, it is still unclear their long-term effect. Hence, it must be tested its contribution in tobacco reduction. This protocol in particularly innovative, since it aims to test the efficacy of electronic devices in a screening program (the lung cancer prevention program COSMOS II at the IEO), where tobacco reduction is strictly needed in order to lower individual's risk.

Methods and Design. This experimental protocol has been designed with the main aim to investigate the role of Tobacco Free Cigarettes (TFC), also called e-cigarettes, in helping smokers to improve their lung health and to quit or reduce tobacco consuming. In particular, the investigators aim at investigating clinical (physical symptoms, with particular focus on breathing quality and difficulties), the behavioral (number of tobacco cigarettes smoked), and psychological (wellbeing, mood and quality of life) effects of shifting to TFC.

The investigators will also analyze, as a secondary aim, the psychological and lifestyle component of smokers involved in order to fine correlation data that might be used to compute a predictor index able to suggest the probability of success, with respect to the reduction of tobacco consuming, of the use of a TFC and to maintain the abstinence. The study will be organized as a nested randomized controlled study with two arms: one experimental group and one control group. The study will be nested in the screening program for lung cancer, where subjects will be recruited.

All subjects will be entered in a psycho-cognitive low-intensity counseling program (6 months), but in the experimental group a TFC (with or without nicotine) will be used as replacement device for three months, while in the control group only low-intensity counseling will be provided. Furthermore, a low-cost non-invasive electronic device (the FitBit activity tracker) will be used in order to monitor behavioral (lifestyle), sleep quality and physical activities.


Options:
A: Arm Label: Placebo Arm; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Arm Label: Treatment Arm; Type: ACTIVE_COMPARATOR; Interventions: Drug: varenicline (CP-526,555) | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Placebo Arm | Intervention Type: DRUG; Name: varenicline (CP-526,555); Assigned to Arm(s): Treatment Arm
B: Arm Label: Varenicline treatment as usual (TAU); Type: EXPERIMENTAL; Interventions: Drug: Varenicline | Arm Label: Varenicline directly observed therapy; Type: EXPERIMENTAL; Interventions: Drug: Varenicline | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Varenicline directly observed therapy, Varenicline treatment as usual (TAU)
C: Arm Label: Menthol ban only for cigarettes; Type: EXPERIMENTAL; Interventions: Other: Menthol ban on cigarettes | Arm Label: Menthol ban for cigarettes and e-cigarettes; Type: EXPERIMENTAL; Interventions: Other: Menthol ban on cigarettes and e-cigarettes | Arm Label: No Menthol Ban; Type: OTHER; Interventions: Other: No menthol ban | Intervention Type: OTHER; Name: Menthol ban on cigarettes; Assigned to Arm(s): Menthol ban only for cigarettes | Intervention Type: OTHER; Name: Menthol ban on cigarettes and e-cigarettes; Assigned to Arm(s): Menthol ban for cigarettes and e-cigarettes | Intervention Type: OTHER; Name: No menthol ban; Assigned to Arm(s): No Menthol Ban
D: Arm Label: Nicotine; Type: EXPERIMENTAL; Interventions: Behavioral: Smoking cessation program TFC and activity tracker | Arm Label: Nicotine-free; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Smoking cessation program TFC-free and activity tracker | Arm Label: No-cig; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Smoking cessation program and activity tracker | Intervention Type: BEHAVIORAL; Name: Smoking cessation program TFC and activity tracker; Assigned to Arm(s): Nicotine | Intervention Type: BEHAVIORAL; Name: Smoking cessation program TFC-free and activity tracker; Assigned to Arm(s): Nicotine-free | Intervention Type: BEHAVIORAL; Name: Smoking cessation program and activity tracker; Assigned to Arm(s): No-cig

Answer: D