Early Smoking Reduction or Cessation by Means of no Nicotine Electronic Cigarette Added to Standard Counselling.

NCT ID: NCT01733706

Last Updated: 2017-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2015-12-31

Brief Summary

The aim of this study is the evaluation of early smoking reduction or cessation by means of no nicotine electronic cigarette added to standard counselling.

Detailed Description

Cigarette smoking is one of the major health problems in the modern world for the impact on morbidity and mortality with devastating effects on cardio-cerebrovascular system and on tumor onset. After years of scientific doubts, today the scientific world agrees to define cigarette smoking not a "vice" but a disease.

The aim is to evaluate the effect of no nicotine electronic cigarette use in patients with cancer or myocardial infarction, smoking at least 10 cigarettes per day for at least 10 years, in addition to counselling activity performed by specialised dedicated medical doctors.

If patient is eligible for this trial, he will be enrolled in this trial and randomized. Randomization will be performed using a web-based procedure. Study participants will be randomized to electronic cigarette added to standard counselling or only standard counselling. A calendar will be given to the patient to remember the dates of visits or telephone counselling. After the first visit patient will be followed every ten days for the first two month through outpatient clinic visits and telephone counselling. After the first two months patient will return at institute for a last outpatient clinic visit at sixth month.

Conditions

Cancer; Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard counseling

a psychologist will provide standard counseling

Group Type: ACTIVE_COMPARATOR

Standard counseling

Intervention Type: OTHER

standard counseling

No nicotine electronic cigarette

patients will receive standard counseling as well as an electronic cigarette

Group Type: EXPERIMENTAL

No nicotine electronic cigarette

Intervention Type: DEVICE

The e-cigarette "T-FUMOTM" is a no nicotine electronic cigarette specifically designed to inactivate the early effects of the cessation of cigarette smoking, such as the craving caused by psychological reasons. It's formed by a filter which contains distilled water and food flavorings, an atomizer and a battery. On the opposite end to the filter there is a diode that lights up during aspiration. During the suction is generated hot air which, in contact with the liquid of the filter, generates steam which simulates the smoke of a traditional cigarette. The smoker has the sensation of smoking, but he does not suck the carcinogenic substances in traditional cigarettes and he does not assimilate nicotine.

Standard counseling

Intervention Type: OTHER

standard counseling

Interventions

No nicotine electronic cigarette

The e-cigarette "T-FUMOTM" is a no nicotine electronic cigarette specifically designed to inactivate the early effects of the cessation of cigarette smoking, such as the craving caused by psychological reasons. It's formed by a filter which contains distilled water and food flavorings, an atomizer and a battery. On the opposite end to the filter there is a diode that lights up during aspiration. During the suction is generated hot air which, in contact with the liquid of the filter, generates steam which simulates the smoke of a traditional cigarette. The smoker has the sensation of smoking, but he does not suck the carcinogenic substances in traditional cigarettes and he does not assimilate nicotine.

Intervention Type: DEVICE

Standard counseling

standard counseling

Intervention Type: OTHER

Other Intervention Names

e-cigarette "T-FUMOTM"

Eligibility Criteria

Inclusion Criteria

• patients with a diagnosis of cancer and recently operated at European Institute of Oncology at Milan (Italy);
• patients with a diagnosis of hematology cancer treated at Foundation "San Raffaele del Monte Tabor" at Milan;
• patient with a recent occurrence of acute myocardial infarction from Monzino Cardiology Centre at Milan;
• age greater than 18 years;
• smokers stable for at least 10 cigarettes per day for at least 10 years.

Exclusion Criteria

• patients with life expectancy less than 6 months;
• patients who have undertaken structured attempts to stop smoking over the past 3 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlo Cipolla, MD

Role: STUDY_CHAIR

European Institute of Oncology

Locations

European Institute of Oncology

Milan, , Italy

Istituto Scientifico San Raffaele del Monte Tabor IRCCS

Milan, , Italy

Countries

Italy

Other Identifiers

IEO S617/211

Identifier Type: -

Identifier Source: org_study_id