Status:
COMPLETED
Efficacy and Safety of an Electronic Nicotine Delivery Device (E-Cigarette) Without Nicotine Cartridges
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) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Sec...
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, between 18 and 60 years of age. They should report a cigarette intake of ≥ 15 cig/day for at least 5 years. At screening they must provide a CO level of ≥ 15 ppm and an FTND ≥ 5.
Exclusion
- alcohol and illicit drug use, breastfeeding, or pregnancy. Individuals who report current attempts to quit smoking and previous experience with electronic cigarettes will be also excluded.
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
NCT01194583
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