Smoking Cessation and Reduction With an Electronic Nicotine Delivery Device (ENDD)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of an Electronic Nicotine Delivery Device (ENDD) on Smoking Cessation and Reduction: a Pilot Study|
- Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers) [ Time Frame: number of cigarettes/day as assessed at week 24 ] [ Designated as safety issue: No ]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).
- Sustained 80% Reduction in the Number of Cig/Day at Week- 24 From Baseline (Heavy Reducers) [ Time Frame: number of cigarettes/day as assessed at week 24 ] [ Designated as safety issue: No ]Participants were monitored for up to 24 weeks. This is the number of partecipants who sustained 80% reduction at week 24
|Study Start Date:||February 2010|
|Study Completion Date:||July 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Experimental: E-Cigarette 7.2 mg nicotine
Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges.
Device: E-Cigarette 7.2 mg nicotine
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
Other Name: E-Cigarette with nicotine cartridges
Cigarette smoking continues to be a very difficult addiction to break. Therefore, improved approaches to smoking cessation are necessary. The electronic-cigarette (e-Cigarette), a battery-powered electronic nicotine delivery device (ENDD) resembling a cigarette, may help smokers to remain abstinent during their quit attempt or to reduce cigarette consumption. The efficacy of these devices in smoking cessation and/or smoking reduction studies has never been investigated.
In this prospective proof-of-concept study we monitored possible modifications in smoking habits of 40 smokers (unwilling to quit) experimenting the 'Categoria' e-Cigarette focusing on smoking reduction and smoking abstinence. Study participants were invited to attend four study visits: at baseline, week-4, week-8, and week-12. Product use, number of cigarettes smoked, and exhaled carbon monoxide (eCO) levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and product preferences were also reviewed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195597
|Dipartimento di Medicina Interna e Specialistica; Centro per la Prevenzione e Cura del Tabagismo (CPCT)|
|Catania, Italy, 95124|
|Principal Investigator:||Riccardo Polosa, MD, PhD||Università di Catania|