Benefits of Tobacco Free Cigarette

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.

Conditions

• Cigarette Smoking
• Smoking Cessation

Interventions

BEHAVIORAL

Smoking cessation program TFC and activity tracker

Participants will receive a free TFC device and sufficient nicotine cartridges (8 mg/ml) to last the last of the procedure. Participants will be instructed to use the device ad libitum one week before their quit day (to be decided at the first contact) to familiarise themselves with its operation and on their designated quit day will stop smoking tobacco cigarettes and instead use the TFC exclusively for the next 11 weeks. The nicotine cartridges use will be monitored through the weekly diary and the monthly telephone. Lifestyle change will be monitored by the use of an activity tracker device (FitBit)

BEHAVIORAL

Smoking cessation program TFC-free and activity tracker

Participants will receive a free TFC device and a set of 10 ml flacons enough to complete the trial. Participants will be instructed to use the device ad libitum one week before their quit day (to be decided at the first contact) to familiarise themselves with its operation and on their designated quit day will stop smoking tobacco cigarettes and instead use the TFC exclusively for the next 11 weeks. The actual use of the device and smoking habits will be monitored through the weekly diary and the monthly telephone. Lifestyle change will be monitored by the use of an activity tracker device (FitBit).

BEHAVIORAL

Smoking cessation program and activity tracker

Participants undergo a motivational interview and low-intensity at distance counseling (the same counseling program of other groups) without any device.The actual smoking habits will be monitored through the weekly diary and the monthly telephone. Lifestyle change will be monitored by the use of an activity tracker device (FitBit).

Sponsors & Collaborators

• Fondazione Umberto Veronesi

  collaborator OTHER

• European Institute of Oncology

  collaborator OTHER

• University of Milan

  lead OTHER

Principal Investigators

• claudio lucchiari, PhD · University of Milan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-09-30

Primary Completion

2015-09-30

Completion

2015-12-31

Countries

• Italy

Study Locations