Benefits of Tobacco Free Cigarette

NCT02422914 | Unknown

• 1 other identifier: R6314
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking; Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Change in psychological wellbeing (had scale)

  baseline, 6 months, 12 months

• Change in number of daily cigarettes

  baseline, 6 months, 12 months

• Change in expired air carbon monoxide concentration

  baseline, 6 months, 12 months

• Change in values of the cough related quality of life questionnaire.

  baseline, 6 months, 12 months

• Change in daily activity (mean number of daily steps)

  baseline, 6 months, 12 months

Study Arms (3)

Nicotine

EXPERIMENTAL

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

Nicotine-free

PLACEBO COMPARATOR

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

No-cig

ACTIVE COMPARATOR

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

Interventions

Smoking cessation program TFC and activity tracker BEHAVIORAL

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)

Nicotine

Smoking cessation program TFC-free and activity tracker BEHAVIORAL

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).

Nicotine-free

Smoking cessation program and activity tracker BEHAVIORAL

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).

No-cig

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects involved in the early lung cancer detection program (Cosmos II) of the European Institute of Oncology.
• Subjects should have smoked at least 10 cigarettes a day for the past 10 years
• Subjects that would like to reduce tobacco smoking but are not willing to be followed by a smoking center
• To have an high motivational scoring (more than 10 points to the motivation questionnaire);
• Signed informed consent

You may not qualify if:

• symptomatic severe cardiovascular disease
• symptomatic severe respiratory disease
• regular psychotropic medication use
• current or past history of alcohol abuse
• use of smokeless tobacco or nicotine replacement therapy
• pregnancy or breastfeeding.
• Subjects involved in other antismoking program in the current year.

Sponsors & Collaborators

• University of Milan: lead
• Fondazione Umberto Veronesi: collaborator
• European Institute of Oncology: collaborator

Study Sites (1)

University of Milan; European Institute of Oncology

Milan, Milan, 20142, Italy

RECRUITING

Related Publications (6)

• 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.

  PMID: 20528810 BACKGROUND

• 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.

  PMID: 23496861 BACKGROUND

• 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.

  PMID: 23826093 BACKGROUND

• 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.

  PMID: 21989407 BACKGROUND

• 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.

  PMID: 18308420 BACKGROUND

• Lucchiari C, Masiero M, Veronesi G, Maisonneuve P, Spina S, Jemos C, Omodeo Sale E, Pravettoni G. Benefits of E-Cigarettes Among Heavy Smokers Undergoing a Lung Cancer Screening Program: Randomized Controlled Trial Protocol. JMIR Res Protoc. 2016 Feb 3;5(1):e21. doi: 10.2196/resprot.4805.

  PMID: 26842790 DERIVED

MeSH Terms

Conditions

Cigarette Smoking; Smoking Cessation

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Health Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• claudio lucchiari, PhD

  University of Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianna Masiero, PhD

CONTACT

+390294372054; marianna.masiero@ieo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: April 22, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 22, 2015

Record last verified: 2015-01

Locations

IT (1)