Healthy Smokers, Smoking Cessation
Conditions
Keywords
electronic cigarette, nicotine, smoking cessation, smoking reduction
Brief summary
The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (E-Cigarette) loaded with low dose nicotine to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to investigate changes in withdrawal symptoms and cravings and to examine whether concomitant use of the E-Cigarette and smoking is safe. The study will monitor smoking reduction/abstinence effects, changes in withdrawal symptoms, and adverse events of a currently marketed device in Italy (Categoria electronic cigarette) using initially for 6 weeks ORIGINAL 7.4 mg nicotine cartridges followed by a further 6 weeks of CATEGORIA 5.2 mg nicotine cartridges. The primary hypothesis is that the E-Cigarette used in a structured protocol is a safe device that allows smoking reduction or abstinence in smokers possibly by suppressing withdrawal symptoms and cravings.
Detailed description
The electronic cigarette (E-Cigarette) is an electronic nicotine delivery systems designed for the purpose of nicotine delivery to the respiratory system where nor tobacco nor combustion are necessary for its operation. For these reasons, it is possible that this product may be safer than cigarettes. Marketing claims also include that they can be useful smoking cessation aids. Although E-Cigarette may produce lung delivery of nicotine similar to that of tobacco cigarettes and reproduces the gesture component associated with tobacco smoking, very little is known about the effect of E-Cigarette on the smoking habits of regular tobacco smokers. Therefore, we designed a prospective observational study consisting of 8 office-based visits (a baseline visit and a 2, 4, 6, 8, 10, and 12-weeks and a final visit at 24-weeks) to monitor possible modifications in the smoking habits of a group of well characterized regular smokers experimenting the e-cigarette focusing on long-term smoking reduction/abstinence, changes in withdrawal symptoms/cravings and adverse events. Specifically, 100 smokers will be given Categoria electronic cigarette initially loaded with ORIGINAL 7.4 mg nicotine cartridges for 6 weeks followed by CATEGORIA 5.2 mg nicotine cartridges for a further 6 weeks. A final follow up visit will be carried out at 24 weeks.
Interventions
None listed
Sponsors
Lega Italiana Anti Fumo
Arbi Group Srl
Universita degli Studi di Catania
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy smokers unwilling to quit * 18 and 60 years of age * cigarette intake of ≥ 15 cig/day for at least 5 years * CO level of ≥ 15 ppm * FTND ≥ 5
Exclusion criteria
* alcohol and illicit drug use * breastfeeding, or pregnancy * current attempts to quit smoking * previous experience with electronic cigarettes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline | week-12 | 50% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, and -12) |
| Sustained smoking abstinence at week-12 | week 12 | Sustained smoking abstinence at week-12, defined as complete abstinence from tobacco smoking (not even a puff) for the 14 days period prior to week-12 study visit; exhaled CO levels will be measured to objectively verify smoking status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained 50% reduction in the number of cigarettes smoked per day at week-24 from baseline | week-24 | 50% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, -12 and -24). |
| Sustained 80% reduction in the number of cigarettes smoked per day at week-24 from baseline | week-24 | 80% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, -12 and -24). |
| Sustained 80% reduction in the number of cigarettes smoked per day at week-12 from baseline | week-12 | 80% reduction in the number of cigarettes smoked per day documented at each study visit (week-2, -4, -6, -8, -10, and -12). |
| Cravings reduction (by VAS) | 24 wks | — |
| Reported adverse events rate from baseline | 24 wks | — |
| Withdrawal suppression (by MNWS) | 24 weeks | — |
| Sustained smoking abstinence at week-24 | week 24 | Sustained smoking abstinence at week-24, defined as complete abstinence from tobacco smoking (not even a puff) for the 30 days period prior to week-24 study visit; exhaled CO levels will be measured to objectively verify smoking status. |
Countries
Italy
Outcome results
None listed