Historique
Article de Périodique
EffiCiency and safety of an eLectronic cigAreTte (ECLAT) as tobacco cigarettes substitute: A prospective 12-month randomized control design study (2013)
Auteur(s) :
CAPONNETTO, P. ;
CAMPAGNA, D. ;
CIBELLA, F. ;
MORJARIA, J. B. ;
CARUSO, M. ;
RUSSO, C. ;
POLOSA, R.
Année
2013
Page(s) :
e66317
Langue(s) :
Anglais
Refs biblio. :
39
Domaine :
Tabac / Tobacco / e-cigarette
Discipline :
EPI (Epidémiologie / Epidemiology)
Thésaurus géographique
ITALIE
Thésaurus mots-clés
E-CIGARETTE
;
ETUDE PROSPECTIVE
;
ETUDE RANDOMISEE
;
EFFICACITE
;
SECURITE
;
SUBSTITUTS NICOTINIQUES
;
SEVRAGE
;
TABAC
;
REDUCTION DE CONSOMMATION
Résumé :
Background: Electronic cigarettes (e-cigarettes) are becoming increasingly popular with smokers worldwide. Users report buying them to help quit smoking, to reduce cigarette consumption, to relieve tobacco withdrawal symptoms, and to continue having a ‘smoking’ experience, but with reduced health risks. Research on e-cigarettes is urgently needed in order to ensure that the decisions of regulators, healthcare providers and consumers are based on science.
Methods: ECLAT is a prospective 12-month randomized, controlled trial that evaluates smoking reduction/abstinence in 300 smokers not intending to quit experimenting two different nicotine strengths of a popular e-cigarette model (‘Categoria’; Arbi Group Srl, Italy) compared to its non-nicotine choice. GroupA (n = 100) received 7.2 mg nicotine cartridges for 12 weeks; GroupB (n = 100), a 6-week 7.2 mg nicotine cartridges followed by a further 6-week 5.4 mg nicotine cartridges; GroupC (n = 100) received no-nicotine cartridges for 12 weeks. The study consisted of nine visits during which cig/day use and exhaled carbon monoxide (eCO) levels were measured. Smoking reduction and abstinence rates were calculated. Adverse events and product preferences were also reviewed.
Results: Declines in cig/day use and eCO levels were observed at each study visits in all three study groups (p<0.001 vs baseline), with no consistent differences among study groups. Smoking reduction was documented in 22.3% and 10.3% at week-12 and week-52 respectively. Complete abstinence from tobacco smoking was documented in 10.7% and 8.7% at week-12 and week-52 respectively. A substantial decrease in adverse events from baseline was observed and withdrawal symptoms were infrequently reported during the study. Participants’ perception and acceptance of the product under investigation was satisfactory.
Conclusion: In smokers not intending to quit, the use of e-cigarettes, with or without nicotine, decreased cigarette consumption and elicited enduring tobacco abstinence without causing significant side effects.
Trial Registration: ClinicalTrials.gov NCT01164072 NCT01164072
Methods: ECLAT is a prospective 12-month randomized, controlled trial that evaluates smoking reduction/abstinence in 300 smokers not intending to quit experimenting two different nicotine strengths of a popular e-cigarette model (‘Categoria’; Arbi Group Srl, Italy) compared to its non-nicotine choice. GroupA (n = 100) received 7.2 mg nicotine cartridges for 12 weeks; GroupB (n = 100), a 6-week 7.2 mg nicotine cartridges followed by a further 6-week 5.4 mg nicotine cartridges; GroupC (n = 100) received no-nicotine cartridges for 12 weeks. The study consisted of nine visits during which cig/day use and exhaled carbon monoxide (eCO) levels were measured. Smoking reduction and abstinence rates were calculated. Adverse events and product preferences were also reviewed.
Results: Declines in cig/day use and eCO levels were observed at each study visits in all three study groups (p<0.001 vs baseline), with no consistent differences among study groups. Smoking reduction was documented in 22.3% and 10.3% at week-12 and week-52 respectively. Complete abstinence from tobacco smoking was documented in 10.7% and 8.7% at week-12 and week-52 respectively. A substantial decrease in adverse events from baseline was observed and withdrawal symptoms were infrequently reported during the study. Participants’ perception and acceptance of the product under investigation was satisfactory.
Conclusion: In smokers not intending to quit, the use of e-cigarettes, with or without nicotine, decreased cigarette consumption and elicited enduring tobacco abstinence without causing significant side effects.
Trial Registration: ClinicalTrials.gov NCT01164072 NCT01164072
Affiliation :
Centro per la Prevenzione e Cura del Tabagismo, Azienda Ospedaliero-Universitaria "Policlinico-V. Emanuele", Universita di Catania, Catania, Italy