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Benefits of Tobacco Free Cigarette (BETOFREE)

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ClinicalTrials.gov Identifier: NCT02422914
Recruitment Status : Unknown
Verified January 2015 by claudio lucchiari, University of Milan.
Recruitment status was:  Recruiting
First Posted : April 22, 2015
Last Update Posted : April 22, 2015
Sponsor:
Collaborators:
Fondazione Umberto Veronesi
European Institute of Oncology
Information provided by (Responsible Party):
claudio lucchiari, University of Milan

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.


Condition or disease Intervention/treatment Phase
Cigarette Smoking Smoking Cessation Behavioral: Smoking cessation program TFC and activity tracker Behavioral: Smoking cessation program TFC-free and activity tracker Behavioral: Smoking cessation program and activity tracker Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Benefits of Tobacco Free Cigarette Among Heavy Smokers Undergoing a Lung Cancer Screening Program: a Randomized Controlled Study
Study Start Date : September 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nicotine
Smoking cessation program TFC and activity tracker. Three months low intensity counselling at distance program. Subject will also undergo a 3-months TFC (with nicotine) program; subjects smoking behaviour and wellbeing will be assessed at baseline, at 6 months and at one year. Life style will be evaluted by the use of an activity tracker and ad-hoc items.
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)

Placebo Comparator: Nicotine-free
Smoking cessation program TFC-free and activity tracker. Three months low intensity counselling at distance program. Subject will also undergo a 3-months TFC (nicotine-free) program; subjects smoking behaviour and wellbeing will be assessed at baseline, at 6 months and at one year. Life style will be evaluted by the use of an activity trackerand ad-hoc items.
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).


Active Comparator: No-cig
Smoking cessation program and activity tracker. Three months low intensity counselling at distance program;subjects smoking behaviour and wellbeing will be assessed at baseline, at 6 months and at one year. Life style will be evaluted by the use of an activity tracker and ad-hoc items.
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).




Primary Outcome Measures :
  1. Change in pulmonary health (dry cough, breath shortness, mouth irritation) index [ Time Frame: baseline, 6 months, 12 months ]
    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.


Secondary Outcome Measures :
  1. Change in psychological wellbeing (had scale) [ Time Frame: baseline, 6 months, 12 months ]
    To evaluate psychological and behavioral (lifestyle) effect of the TFC-based program

  2. Change in number of daily cigarettes [ Time Frame: baseline, 6 months, 12 months ]
    To assess the smoking behaviour within the three groups

  3. Change in expired air carbon monoxide concentration [ Time Frame: baseline, 6 months, 12 months ]
    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.

  4. Change in values of the cough related quality of life questionnaire. [ Time Frame: baseline, 6 months, 12 months ]
    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.

  5. Change in daily activity (mean number of daily steps) [ Time Frame: baseline, 6 months, 12 months ]
    To evaluate psychological and behavioral (lifestyle) effect of the TFC-based program

  6. Change in lifstyle as measure by ad-hoc questionnaires [ Time Frame: baseline, 6 months, 12 months ]
    To evaluate psychological and behavioral (lifestyle) effect of the TFC-based program



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422914


Contacts
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Contact: Marianna Masiero, PhD +390294372054 marianna.masiero@ieo.it

Locations
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Italy
University of Milan; European Institute of Oncology Recruiting
Milan, Italy, 20142
Contact: Marianna Masiero, PhD    +390294372054    marianna.masiero@ieo.it   
Sponsors and Collaborators
University of Milan
Fondazione Umberto Veronesi
European Institute of Oncology
Investigators
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Principal Investigator: claudio lucchiari, PhD University of Milan

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: claudio lucchiari, Prof, University of Milan
ClinicalTrials.gov Identifier: NCT02422914     History of Changes
Other Study ID Numbers: R6314
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action