Early Smoking Reduction or Cessation by Means of no Nicotine Electronic Cigarette Added to Standard Counselling.
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|ClinicalTrials.gov Identifier: NCT01733706|
Recruitment Status : Completed
First Posted : November 27, 2012
Last Update Posted : February 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer Myocardial Infarction||Device: No nicotine electronic cigarette Other: Standard counseling||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Early Smoking Reduction or Cessation by Means of no Nicotine Electronic Cigarette Added to Standard Counselling.|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Active Comparator: Standard counseling
a psychologist will provide standard counseling
Other: Standard counseling
Experimental: No nicotine electronic cigarette
patients will receive standard counseling as well as an electronic cigarette
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 Name: e-cigarette "T-FUMOTM"
Other: Standard counseling
- 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
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): NCT01733706
|European Institute of Oncology|
|Istituto Scientifico San Raffaele del Monte Tabor IRCCS|
|Study Chair:||Carlo Cipolla, MD||European Institute of Oncology|