Early Smoking Reduction or Cessation by Means of no Nicotine Electronic Cigarette Added to Standard Counselling.
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cancer Myocardial Infarction. |
Device: No nicotine electronic cigarette Other: Standard counseling |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of Early Smoking Reduction or Cessation by Means of no Nicotine Electronic Cigarette Added to Standard Counselling. |
- Number of cigarettes smoked [ Time Frame: two months after event (cancer or myocardial infarction) ] [ Designated as safety issue: No ]
- psychological conditions [ Time Frame: two months after event (cancer or myocardial infarction) ] [ Designated as safety issue: No ]psychological conditions will be assessed by questionnaire
| Estimated Enrollment: | 126 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Standard counseling
a psychologist will provide standard counseling
|
Other: Standard counseling
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
standard counseling
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Italy | |
| European Institute of Oncology | Recruiting |
| Milan, Italy | |
| Contact: Carlo Cipolla, MD +39 02 57 489 706 carlo.cipolla@ieo.it | |
| Principal Investigator: Carlo Cipolla, MD | |
| Istituto Scientifico San Raffaele del Monte Tabor IRCCS | Recruiting |
| Milan, Italy | |
| Contact: Fabio Ciceri, MD +39 0226437703 fabio.ciceri@hsr.it | |
| Study Chair: | Carlo Cipolla, MD | European Institute of Oncology |
More Information
No publications provided
| Responsible Party: | European Institute of Oncology |
| ClinicalTrials.gov Identifier: | NCT01733706 History of Changes |
| Other Study ID Numbers: | IEO S617/211 |
| Study First Received: | November 21, 2012 |
| Last Updated: | November 26, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by European Institute of Oncology:
|
No Nicotine Electronic Cigarette Antismoke intervention |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Nicotine Nicotine polacrilex Ganglionic Stimulants |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013