Smoking Cessation Clinical Trial
— BETOFREEOfficial title:
Benefits of Tobacco Free Cigarette Among Heavy Smokers Undergoing a Lung Cancer Screening Program: a Randomized Controlled Study
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.
Status | Recruiting |
Enrollment | 210 |
Est. completion date | December 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Subjects involved in the early lung cancer detection program (Cosmos II) of the European Institute of Oncology. 2. Subjects should have smoked at least 10 cigarettes a day for the past 10 years 3. Subjects that would like to reduce tobacco smoking but are not willing to be followed by a smoking center 4. To have an high motivational scoring (more than 10 points to the motivation questionnaire); 5. Signed informed consent Exclusion Criteria: 1. symptomatic severe cardiovascular disease 2. symptomatic severe respiratory disease 3. regular psychotropic medication use 4. current or past history of alcohol abuse 5. use of smokeless tobacco or nicotine replacement therapy 6. pregnancy or breastfeeding. 7. Subjects involved in other antismoking program in the current year. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | University of Milan; European Institute of Oncology | Milan |
Lead Sponsor | Collaborator |
---|---|
University of Milan | European Institute of Oncology, Fondazione Umberto Veronesi |
Italy,
Bullen C, Howe C, Lin RB, Grigg M, Laugesen M, McRobbie H, Glover M, Walker N, Wallace-Bell M, Whittaker R, Rodgers A. Pre-cessation nicotine replacement therapy: pragmatic randomized trial. Addiction. 2010 Aug;105(8):1474-83. doi: 10.1111/j.1360-0443.2010.02989.x. Epub 2010 Jun 7. — View Citation
Bullen C, Williman J, Howe C, Laugesen M, McRobbie H, Parag V, Walker N. Study protocol for a randomised controlled trial of electronic cigarettes versus nicotine patch for smoking cessation. BMC Public Health. 2013 Mar 8;13:210. doi: 10.1186/1471-2458-13-210. — View Citation
Caponnetto P, Campagna D, Cibella F, Morjaria JB, Caruso M, Russo C, Polosa R. EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as tobacco cigarettes substitute: a prospective 12-month randomized control design study. PLoS One. 2013 Jun 24;8(6):e66317. doi: 10.1371/journal.pone.0066317. Print 2013. Erratum in: PLoS One. 2014;9(1). doi:10.1371/annotation/e12c22d3-a42b-455d-9100-6c7ee45d58d0. — View Citation
Polosa R, Caponnetto P, Morjaria JB, Papale G, Campagna D, Russo C. Effect of an electronic nicotine delivery device (e-Cigarette) on smoking reduction and cessation: a prospective 6-month pilot study. BMC Public Health. 2011 Oct 11;11:786. doi: 10.1186/1471-2458-11-786. — View Citation
Veronesi G, Bellomi M, Mulshine JL, Pelosi G, Scanagatta P, Paganelli G, Maisonneuve P, Preda L, Leo F, Bertolotti R, Solli P, Spaggiari L. Lung cancer screening with low-dose computed tomography: a non-invasive diagnostic protocol for baseline lung nodules. Lung Cancer. 2008 Sep;61(3):340-9. doi: 10.1016/j.lungcan.2008.01.001. Epub 2008 Mar 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in pulmonary health (dry cough, breath shortness, mouth irritation) index | To evaluate the impact of a three months TFC program to reduce smoking-related respiratory symptoms (dry cough, breath shortness, mouth irritation and catarrh) as consequence of a reduced tobacco cigarettes consumption among a CT screening population. | baseline, 6 months, 12 months | No |
Secondary | Change in psychological wellbeing (had scale) | To evaluate psychological and behavioral (lifestyle) effect of the TFC-based program | baseline, 6 months, 12 months | No |
Secondary | Change in number of daily cigarettes | To assess the smoking behaviour within the three groups | baseline, 6 months, 12 months | No |
Secondary | Change in expired air carbon monoxide concentration | To evaluate the impact of a three months TFC program to reduce smoking-related respiratory symptoms (dry cough, breath shortness, mouth irritation and catarrh) as consequence of a reduced tobacco cigarettes consumption among a CT screening population. | baseline, 6 months, 12 months | No |
Secondary | Change in values of the cough related quality of life questionnaire. | To evaluate the impact of a three months TFC program to reduce smoking-related respiratory symptoms (dry cough, breath shortness, mouth irritation and catarrh) as consequence of a reduced tobacco cigarettes consumption among a CT screening population. | baseline, 6 months, 12 months | No |
Secondary | Change in daily activity (mean number of daily steps) | To evaluate psychological and behavioral (lifestyle) effect of the TFC-based program | baseline, 6 months, 12 months | No |
Secondary | Change in lifstyle as measure by ad-hoc questionnaires | To evaluate psychological and behavioral (lifestyle) effect of the TFC-based program | baseline, 6 months, 12 months | No |
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