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

NCT01733706 | Completed

• 1 other identifier: IEO S617/211
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer; Myocardial Infarction

Keywords

No Nicotine Electronic Cigarette; Antismoke intervention

Outcome Measures

Primary Outcomes (2)

• Number of cigarettes smoked

  two months after event (cancer or myocardial infarction)

• psychological conditions

  psychological conditions will be assessed by questionnaire

  two months after event (cancer or myocardial infarction)

Study Arms (2)

Standard counseling

ACTIVE COMPARATOR

a psychologist will provide standard counseling

Other: Standard counseling

No nicotine electronic cigarette

EXPERIMENTAL

patients will receive standard counseling as well as an electronic cigarette

Device: No nicotine electronic cigarette; Other: Standard counseling

Interventions

No nicotine electronic cigarette 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.

Also known as: e-cigarette "T-FUMOTM"

No nicotine electronic cigarette

Standard counseling OTHER

standard counseling

No nicotine electronic cigarette; Standard counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (2)

European Institute of Oncology

Milan, Italy

Location

Istituto Scientifico San Raffaele del Monte Tabor IRCCS

Milan, Italy

Location

MeSH Terms

Conditions

Neoplasms; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Carlo Cipolla, MD

  European Institute of Oncology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: November 27, 2012
• Study Start: June 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 9, 2017

Record last verified: 2015-12

Locations

IT (2)