Electronic cigarettes (e-cigarettes) have proved very popular and a meteoric rise in their usage is currently under way. People purchase them as an aid to giving up smoking, to reduce cigarette consumption, to minimise withdrawal symptoms in occupational environments that ban smoking, and in order to continue smoking with decreased health risks. Although the safety and impact on health of electronic cigarettes, especially after long-term use, has not been evaluated, they are generally considered to be far safer alternatives to cigarette smoke. Electronic cigarettes do not generate polycyclic aromatic hydrocarbons, a potent class of carcinogenic chemicals generated during the combustion of tobacco and making important contribution to the cigarette-induced cancer. However, carcinogenic tobacco-specific nitrosamines have been encountered in e-cigarettes being detected in some nicotine cartridges as contaminants, albeit at very low concentrations in comparison with tobacco smoke. Consequently, it is imperative to ascertain the toxicity risk (if any) of consuming nicotine intake through electronic cigarettes. This European Commission funded study will monitor levels of carcinogenic tobacco-specific nitrosamines in urine of heavy smokers who give up smoking and completely transition to e-cigarette use for a period of 4 weeks. Levels of other compounds which are known to be associated with smoking toxicity, such as DNA adducts and DNA methylation, will also be monitored in biological fluids of these subjects. Finally, cigarette craving, mood, anxiety, social anxiety, well-being status and stress hormones will be measured in smokers transitioning to e-cigarettes for 4 weeks to assess the psychological effect of the transition. The results from the study will provide important information on the safety and effectiveness of e-cigarettes for smoking cessation which investigators anticipate to drive policy.
Established smokers will completely stop smoking for 4 weeks and instead transition to nicotine use through an electronic cigarette as required. They will be free to purchase the e-cigarette and e-liquid/cartridges of their own choice. Eligible subjects will be asked to visit St George's Clinical Research Facility to provide the following samples. Blood, saliva and buccal cells to be collected on screening day. 24hr urine, blood, saliva and buccal cells will be collected at baseline and on days 3, 7, 21 and 28 after the first transition to e-cigarette use. Moreover, subjects will be breathalysed with carbon monoxide (CO) oximeter and their urine analysed for anatabine to assess compliance to the study protocol (complete refrain of use of tobacco cigarettes for 4 weeks while they use e-cigarettes). Subjects will be monitored for craving, mood, social anxiety, sleep profile and quality of life on every visit to St George's Clinical Research Facility (quality of life will be assessed only at baseline and day 28 of e-cigarette use). The subjects will be followed up with a telephone call 6 and 12 months after the end of the e-cigarette intervention to monitor their smoking/e-cigarette use behaviour and participants craving, mood, social anxiety, sleep profile and quality of life.
Study Type
OBSERVATIONAL
Enrollment
50
St George's Hospital
London, United Kingdom
Change of levels of DNA adducts analysed by high resolution liquid chromatography
Time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Change of levels of tobacco specific nitrosamines analysed by high resolution liquid chromatography
Time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Change of levels of stress hormones analysed by ELISA
Time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Change of levels of DNA methylation analysed by high pressure liquid chromatography-UV
Time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Change of measures of withdrawal symptoms severity measured by the Fagerstrom test
Time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Change of measures of craving analysed by Minnesota Nicotine Withdrawal Scale
Time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Change of measures of mood analysed by Mood and Physical Symptoms Scale (MPSS)
Time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Change of measures of anxiety analysed by State-Trait Anxiety Inventory
Time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Change of measures of social anxiety analysed by Liebovitz Social Anxiety Test
Time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Changes of measures of depression analysed by Beck Depression Inventory
Time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Changes of measures of sleep analysed by Pittsburg Sleep Index or Karolinska sleep questionaire
Time frame: Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes
Changes of measure of quality of life analysed by the European Quality of Life Questionnaire (EuroQL-5D)
Time frame: baseline and 28 days following transition to e-cigarettes
Changes in brain electrical activity measured by EEG
Time frame: baseline and 21 days following transition to e-cigarettes
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