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

Overview

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.

Full Title of Study: “Evaluation of Early Smoking Reduction or Cessation by Means of no Nicotine Electronic Cigarette Added to Standard Counselling.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

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.

Interventions

  • Device: 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.
  • Other: Standard counseling
    • standard counseling

Arms, Groups and Cohorts

  • Active Comparator: Standard counseling
    • a psychologist will provide standard counseling
  • Experimental: No nicotine electronic cigarette
    • patients will receive standard counseling as well as an electronic cigarette

Clinical Trial Outcome Measures

Primary Measures

  • Number of cigarettes smoked
    • Time Frame: two months after event (cancer or myocardial infarction)
  • psychological conditions
    • Time Frame: two months after event (cancer or myocardial infarction)
    • psychological conditions will be assessed by questionnaire

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • European Institute of Oncology
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Carlo Cipolla, MD, Study Chair, European Institute of Oncology

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