Nicotine Dependence, Smoking Cessation
Conditions
Keywords
electronic cigarette, ENDD, nicotine, smoking cessation, smoking reduction
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.
Interventions
DEVICEE-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
Sponsors
Lega Italiana Anti Fumo
Arbi Group Srl
Universita degli Studi di Catania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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 * FTND ≥ 5
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Participants were monitored for up to 24 weeks. This is the number of partecipants who sustained 80% reduction at week 24 |
Countries
Italy
Participant flow
Recruitment details
Healthy smokers 18-60 years old, smoking ≥ 15 factorymade cigarettes per day (cig/day) for at least the past 10 years and not currently attempting to quit smoking or wishing to do so in the next 30 days were recruited, Italy. None of the participants reported a history of alcohol and drug use, major depression or other psychiatric conditions.
Participants by arm
| Arm | Count |
|---|---|
| ENDD Group Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | ENDD Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Age Continuous | 42.9 years STANDARD_DEVIATION 8.8 |
| Region of Enrollment Italy | 40 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 22 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
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).
Time frame: number of cigarettes/day as assessed at week 24
Population: Intention to treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Smokers Not Willing to Quit | Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers) | 13 number of participants |
Secondary
Sustained 80% Reduction in the Number of Cig/Day at Week- 24 From Baseline (Heavy Reducers)
Participants were monitored for up to 24 weeks. This is the number of partecipants who sustained 80% reduction at week 24
Time frame: number of cigarettes/day as assessed at week 24
Population: Intention to treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Smokers Not Willing to Quit | Sustained 80% Reduction in the Number of Cig/Day at Week- 24 From Baseline (Heavy Reducers) | 5 number of participants |