Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lega Italiana Anti Fumo | OTHER |
| Arbi Group Srl | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-Cigarette 7.2 mg nicotine | Experimental | Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-Cigarette 7.2 mg nicotine | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | number of cigarettes/day as assessed at week 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Riccardo Polosa, MD, PhD | Università di Catania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dipartimento di Medicina Interna e Specialistica; Centro per la Prevenzione e Cura del Tabagismo (CPCT) | Catania | 95124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23873169 | Derived | 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. | |
| 21989407 | Derived |
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ENDD Group | Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ENDD Group | Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Intention to treat (ITT) | Posted | Number | number of participants | number of cigarettes/day as assessed at week 24 |
|
|
6 months
daily questionnaire
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ENDD Group | Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| troat irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Riccardo Polosa | University of Catania | 0957436413 | 0039 | polosa@unict.it, p.caponnetto@unict.it |
Not provided
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| D000072137 | Vaping |
| D000074264 | Smoking Reduction |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Polosa 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. |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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 | Intention to treat (ITT) | Posted | Number | number of participants | number of cigarettes/day as assessed at week 24 |
|
|
|
| 0 |
| 40 |
| 22 |
| 40 |
| mouth irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D001519 | Behavior |
| D012907 | Smoking |