Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT02752022
Study type Observational
Source St George's, University of London
Contact
Status Active, not recruiting
Phase
Start date September 2016
Completion date April 1, 2019

See also
  Status Clinical Trial Phase
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Adherence to Anti- Retroviral Therapy (ART) Among People Living With Human Immunodeficiency Virus (HIV) Phase 4
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT02649556 - A 26-week Extension of the ZRHR-ERS-09-US Study Evaluating Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2 N/A
Completed NCT03901066 - Smoking Dependence and Periodontitis
Completed NCT03170752 - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP) N/A
Completed NCT03305978 - Pulmonary Nodule Detection: Comparison of an Ultra Low Dose vs Standard Scan. N/A
Completed NCT00000437 - Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone) Phase 4
Completed NCT06105424 - BRP1602: Evaluation of Technical and Logistical Feasibility to Measure Lung Permeability N/A
Completed NCT04340830 - The Effect of Smoking on Dimensional Changes of Free Gingival Graft Around Dental Implants N/A
Completed NCT02901171 - The Contribution of a Smartphone Application to Acceptance and Commitment Therapy Group Treatment for Smoking Cessation N/A
Completed NCT02912000 - TEACH: Technology Evaluation to Address Child Health N/A
Completed NCT03206619 - A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
Completed NCT02949648 - Electronic Cigarette Use and Quitting in Youth N/A
Completed NCT02945371 - Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life N/A
Completed NCT02246114 - Self-Monitoring of Carbon Monoxide to Enhance Reproductive Outcomes in Women N/A
Completed NCT01954407 - Young Adults' Responses to Anti-smoking Messages N/A
Completed NCT01898507 - Nicotine Metabolism and Low Nicotine Cigarettes N/A
Completed NCT03448900 - Intervention Study for Smoking Cessation in Spanish College Students N/A
Completed NCT02008292 - Acetylcholine, Tobacco Smoking, Genes and Nicotinic Receptors N/A
Active, not recruiting NCT01585610 - Motivating Smokers With Mobility Impairments to Quit Smoking Phase 3