Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial
- 1Clinical Trials Research Unit, The University of Auckland, Auckland, New Zealand
- 2Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK
- 3Section of Epidemiology and Biostatistics, The University of Auckland, Auckland, New Zealand
- 4Centre for Tobacco Control Research, The University of Auckland, Auckland, New Zealand
- 5Biometric, Covance Pty Ltd, Sydney, Australia
- 6Health New Zealand Ltd, Christchurch, New Zealand
- Correspondence to Dr Christopher Bullen, Clinical Trials Research Unit, The University of Auckland, Private Bag 92019, Auckland, New Zealand;
Contributors CB, HM, ST, MG, RL and ML designed and conducted the study, interpreted the data, and wrote the manuscript. CB, HM and ST are guarantors.
- Received 15 May 2009
- Accepted 2 December 2009
Objectives To measure the short-term effects of an electronic nicotine delivery device (“e cigarette”, ENDD) on desire to smoke, withdrawal symptoms, acceptability, pharmacokinetic properties and adverse effects.
Design Single blind randomised repeated measures cross-over trial of the Ruyan V8 ENDD.
Setting University research centre in Auckland, New Zealand.
Participants 40 adult dependent smokers of 10 or more cigarettes per day.
Interventions Participants were randomised to use ENDDs containing 16 mg nicotine or 0 mg capsules, Nicorette nicotine inhalator or their usual cigarette on each of four study days 3 days apart, with overnight smoking abstinence before use of each product.
Main outcome measures The primary outcome was change in desire to smoke, measured as “area under the curve” on an 11-point visual analogue scale before and at intervals over 1 h of use. Secondary outcomes included withdrawal symptoms, acceptability and adverse events. In nine participants, serum nicotine levels were also measured.
Results Over 60 min, participants using 16 mg ENDD recorded 0.82 units less desire to smoke than the placebo ENDD (p=0.006). No difference in desire to smoke was found between 16 mg ENDD and inhalator. ENDDs were more pleasant to use than inhalator (p=0.016) and produced less irritation of mouth and throat (p<0.001). On average, the ENDD increased serum nicotine to a peak of 1.3 mg/ml in 19.6 min, the inhalator to 2.1 ng/ml in 32 min and cigarettes to 13.4 ng/ml in 14.3 min.
Conclusions The 16 mg Ruyan V8 ENDD alleviated desire to smoke after overnight abstinence, was well tolerated and had a pharmacokinetic profile more like the Nicorette inhalator than a tobacco cigarette. Evaluation of the ENDD for longer-term safety, potential for long-term use and efficacy as a cessation aid is needed.
Trial registration No.12607000587404, Australia and New Zealand Clinical Trials Register
- electronic nicotine delivery device
- nicotine products
Funding This project was funded by Ruyan Group (Holdings) Limited, Beijing and Hong Kong, via Health New Zealand Ltd. The study sponsors supplied the ENDDs used in the trial and funded the trial. The Clinical Trials Research Unit contracted with Health New Zealand Ltd to conduct the trial, independently of Ruyan Group (Holdings) Ltd. The trial design conduct, analysis and interpretation of results were conducted independently of the sponsors.
Competing interests CB, ST and RL have no competing interests to declare. HM has received honoraria for speaking at research symposia and received benefits in kind and travel support from, and has provided consultancy to the manufacturers of smoking cessation medications. ML acted as contract manager with the sponsor, Ruyan Group (Holdings) Limited, via his company Health New Zealand Ltd. ML and Health New Zealand Ltd have no patent, stock or other financial interest in Ruyan Group (Holdings) Limited or any nicotine or tobacco company. MG has provided consultancy to the manufacturers of smoking cessation medications.
Ethics approval Ethical approval for the trial was obtained from the New Zealand Ministry of Health's Northern Y Ethics Committee (approval number NTY/07/10/109).
Provenance and peer review Not commissioned; externally peer reviewed.