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Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial.

Randomized controlled trial
Bullen C, et al. Tob Control. 2010.

Abstract

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.

PMID

20378585 [PubMed - indexed for MEDLINE]

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