Effect of an Electronic Nicotine Delivery Device (ENDD) on Smoking Cessation and Reduction: a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers)
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •healthy smokers
- •unwilling to quit
- •age 18-60 years
- •smoking ≥ 15 cig/day for at least 5 years
- •exhaled CO level of ≥ 15 ppm
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: E-Cigarette 7.2 mg nicotine (Device)
Outcomes
Primary Outcomes
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
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).
Secondary Outcomes
- 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)
Investigators
Riccardo Polosa
Professor of Internal Medicine
Universita degli Studi di Catania