Updated information can be found at BMJ's Tobacco Control Info page.
Abstract
Objectives: To measure the short-term effects of an electronic nicotine delivery device (e cigarette) on desire to smoke, withdrawal symptoms, acceptability, pharmacokinetic properties and adverse effects.Design: Single blind randomised repeated measures cross-over trial of Ruyan V8 ENDD.
Setting: University research centre in Auckland, New Zealand.
Participants: 40 adult dependent smokes of 10 or more cigarettes per day.
Interventions: Participants were randomised to use ENDDs containing 16 mg nicotine or 0mg 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 curbe" on an 11-point visual analogue scale before and at intervals over 1 hour of use. Secondary outcomes included withdrawal sypmtoms, acceptability and adverse events. In nine participants, serum nicotine levels were also measured.
Results: Over 60 minutes, participants using 16 mg ENDD recorded 0.82 units less desire to smoke than the placebo ENDD (P=0.006). No difference in deisre to smoke was found between 16 mg ENDD and inhalator. ENDDs (E-Cig's) 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 incresed serum nicotine to a peak of 1.3 mg/ml in 19.6 minutes, the inhalator to 2.1 ng/ml in 32 minutes and cifarettes to 13.4 ng/ml in 14.3 minutes.
Conclusions: The 16 mg Tuyan V* 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.
To read the study article, (Click Here).
