Status:
COMPLETED
A Structured Protocol to Evaluate Efficacy and Safety of a Popular Electronic Nicotine Delivery Device (E-Cigarette) Efficacy and Safety of a Popular Electronic Nicotine Delivery Device (E-Cigarette)
Lead Sponsor:
Universita degli Studi di Catania
Collaborating Sponsors:
Lega Italiana Anti Fumo
Arbi Group Srl
Conditions:
Healthy Smokers
Smoking Cessation
Eligibility:
All Genders
18-60 years
Brief Summary
The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (E-Cigarette) loaded with low dose nicotine to induce long-term smoking reduction/abstinence in ...
Detailed Description
The electronic cigarette (E-Cigarette) is an electronic nicotine delivery systems designed for the purpose of nicotine delivery to the respiratory system where nor tobacco nor combustion are necessary...
Eligibility Criteria
Inclusion
- healthy smokers unwilling to quit
- 18 and 60 years of age
- cigarette intake of ≥ 15 cig/day for at least 5 years
- CO level of ≥ 15 ppm
- FTND ≥ 5
Exclusion
- alcohol and illicit drug use
- breastfeeding, or pregnancy
- current attempts to quit smoking
- previous experience with electronic cigarettes
Key Trial Info
Start Date :
April 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01188239
Start Date
April 1 2010
End Date
April 1 2012
Last Update
January 8 2013
Active Locations (1)
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1
Dipartimento di Medicina Interna e Specialistica; Centro per la Prevenzione e Cura del Tabagismo (CPCT)
Catania, Italy, 95124