The role of electronic cigarettes in smoking cessation among heavy smokers undergoing a lung cancer screening program : preliminary results of a randomized controlled study

ABSTRACT Purpose: Electronic cigarettes (e-cigs) is very widespread in high income-countries. Notwithstanding the broad dissemination, very poor data exist testing the long-term effects and the impact on respiratory diseases reduction in high risk population. According to this framework, the main purpose of the study is to assess the power of e-cigs to help heavy smokers quit. Methods: The study design is a prospective, double blinded randomized controlled trial (N=210). Participant are recruited among volunteers participants at a screening program for early lung cancer detection (the COSMOS II program) at the European Institute of Oncology in Milan (Italy). Data collection started in September 2014 and will be concluded until October 2015. Main eligibility criteria are: readiness to start with a quitting attempt (motivation to qui higher than 10), smoking more than 10 cigarettes per day, and not being enrolled in other antismoking treatments or programs. All groups receive a low-intensity psycho-cognitive counseling during the annual COSMOS II screening. In addition, psychological, behavioral, and respiratory parameters are evaluated using a set of standardized questionnaires. Each participant receives a monthly telephone interview, for three months to monitor advancements, to cope with the roadblocks and to provide problem-solving strategies. Participants enrolled in the experimental groups receive an e-cig kit (nicotine versus nicotine free). The study endpoint is at six months with a follow-up and one year. Results: The trial is open and still recruiting. Thus, we present here preliminary results about e-cig group versus only support group. One-hundred and eighty-three subjects are currently enrolled (F= 77, M= 107), the mean age is 62 years (SD= 4.51). The mean number of cigarettes per day is 19.77 (SD=8.47), while CO2 expired is 14.80 ppm (SD=6.08). The dependence level is 4.37 (SD=1.92), while motivational level is 13.01 (SD=2.97). Subjects enrolled in the e-cig group (M=7.94, SD=7.20) compared to the only support group (M=10.692 SD.=6.935) have a significant reduction in daily cigarettes consumption at the first follow-up (1 month), t=-2.278, p<.024.). Conclusions: These data suggest that the integration between psycho-cognitive support and e-cig might aid heavy smokers decrease tobacco consumption. Research Implications: The preliminary results offer pivotal suggestions about the importance of antismoking interventions for individuals enrolled in a screening program, and the usefulness of e-cigs to support smoking quitting attempts in heavy smokers ready to stop. Clinical Implications: Reducing tobacco consumption should be considered a mandatory objective of a screening program to reduce the risk of smoking-related risks and to promote a healthier lifestyle. Our preliminary results suggest that e-cigs may be a valid nicotine replacement therapy for at-risk but healthy smokers who voluntarily decided to participate in a lung cancer screening program. For now, e-cigs are not recommended as tobacco cessation strategy for cancer patients, but this is probably due to lack of scientific evidence about their efficacy and safety in this context. Future studies will provide better indications for oncologists and health personnel involved in the fight against tobacco consumption. Acknowledgement of Funding: The study is supported by a grant from Umberto Veronesi Foundation. Learning Objective: The participant shall be able to understand the practice and clinical implications about the role of the new device for smoking cessation in high risk population.