Lucchiari 2016

Trial name or title	Benefits of tobacco free cigarette among heavy smokers undergoing a lung cancer screening program: a randomized controlled study
Methods	Randomized parallel‐assignment double‐blind trial Setting: Early lung cancer detection programme (Cosmos II) at European Institute of Oncology Recruitment: volunteers participating in screening programme
Participants	Estimated enrolment: 210 Inclusion criteria: Smokers > 10 cpd for > 10 years, motivated to reduce smoking, not already in cessation treatment Exclusion criteria: Symptomatic CVD Symptomatic severe respiratory disease Regular psychotropic medication use Current or past history of alcohol abuse Use of smokeless tobacco or NRT Participation in another antismoking programme in the current year
Interventions	All participants receive smoking cessation programme including a motivational interview and 3 months low‐intensity distance counselling 1) EC and activity tracker 2) Nicotine‐free EC and activity tracker 3) Activity tracker
Outcomes	At 6 and 12m Primary: pulmonary health Secondary: psychological well‐being, cpd, CO, daily activity, cough‐related QoL, lifestyle
Starting date	September 2014
Contact information	Marianna Masiero, University of Milan
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