Smoking Cessation and Reduction With an Electronic Nicotine Delivery Device (ENDD)
Effect of an Electronic Nicotine Delivery Device (ENDD) on Smoking Cessation and Reduction: a Pilot Study
1 other identifier
interventional
40
1 country
1
Brief Summary
The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (ENDD) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to monitor adverse events and measure participants' perception and acceptance of the product. This pilot study will evaluate smoking reduction/abstinence effects, product preferences, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges). The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 3, 2010
CompletedFirst Posted
Study publicly available on registry
September 6, 2010
CompletedResults Posted
Study results publicly available
September 11, 2012
CompletedJanuary 9, 2013
January 1, 2013
4 months
September 3, 2010
May 22, 2012
January 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers)
Participants were monitored for up to 24 weeks. This is the number of smokers who sustained 50% reduction in the number of cig/day at week-24 from baseline (reducers).
number of cigarettes/day as assessed at week 24
Secondary Outcomes (1)
Sustained 80% Reduction in the Number of Cig/Day at Week- 24 From Baseline (Heavy Reducers)
number of cigarettes/day as assessed at week 24
Study Arms (1)
E-Cigarette 7.2 mg nicotine
EXPERIMENTALWell characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges.
Interventions
Participants were given a free e-Cigarette kit containing two rechargeable batteries, a charger, and two atomizers and instructed on how to charge, activate and use the e-Cigarette. Key troubleshooting were addressed and phone numbers were supplied for both technical and medical assistance. A full 4-weeks supply of 7.2 mg nicotine cartridges ("Original" cartridges; Arbi Group Srl, Milano, Italy) was also provided and participants were trained on how to load them onto the e-Cigarette's atomizer
Eligibility Criteria
You may qualify if:
- healthy smokers
- unwilling to quit
- age 18-60 years
- smoking ≥ 15 cig/day for at least 5 years
- exhaled CO level of ≥ 15 ppm
- FTND ≥ 5
You may not qualify if:
- alcohol and illicit drug use
- breastfeeding or pregnancy
- major depression or other psychiatric conditions
- previous experience with ENDD
- recent myocardial infarction
- angina pectoris
- high blood pressure (BP\>140mm Hg systolic and/or 90mmHg diastolic)
- diabetes mellitus
- severe allergies
- poorly controlled asthma or other airways diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universita degli Studi di Catanialead
- Lega Italiana Anti Fumocollaborator
- Arbi Group Srlcollaborator
Study Sites (1)
Dipartimento di Medicina Interna e Specialistica; Centro per la Prevenzione e Cura del Tabagismo (CPCT)
Catania, 95124, Italy
Related Publications (2)
Polosa R, Morjaria JB, Caponnetto P, Campagna D, Russo C, Alamo A, Amaradio M, Fisichella A. Effectiveness and tolerability of electronic cigarette in real-life: a 24-month prospective observational study. Intern Emerg Med. 2014 Aug;9(5):537-46. doi: 10.1007/s11739-013-0977-z. Epub 2013 Jul 20.
PMID: 23873169DERIVEDPolosa R, Caponnetto P, Morjaria JB, Papale G, Campagna D, Russo C. Effect of an electronic nicotine delivery device (e-Cigarette) on smoking reduction and cessation: a prospective 6-month pilot study. BMC Public Health. 2011 Oct 11;11:786. doi: 10.1186/1471-2458-11-786.
PMID: 21989407DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof Riccardo Polosa
- Organization
- University of Catania
Study Officials
- PRINCIPAL INVESTIGATOR
Riccardo Polosa, MD, PhD
Università di Catania
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Internal Medicine
Study Record Dates
First Submitted
September 3, 2010
First Posted
September 6, 2010
Study Start
February 1, 2010
Primary Completion
June 1, 2010
Study Completion
July 1, 2010
Last Updated
January 9, 2013
Results First Posted
September 11, 2012
Record last verified: 2013-01