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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by European Institute of Oncology
Sponsor:
Information provided by (Responsible Party):
European Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01733706
First received: November 21, 2012
Last updated: June 17, 2014
Last verified: June 2014
  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.

Resource links provided by NLM:


Further study details as provided by European Institute of Oncology:

Primary Outcome Measures:
  • 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 2015
Estimated Primary Completion Date: December 2014 (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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733706

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   
Sponsors and Collaborators
European Institute of Oncology
Investigators
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: June 17, 2014
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
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

ClinicalTrials.gov processed this record on October 01, 2014