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

TLDR

Evaluation of the ENDD for longer‑term safety, potential for long‑term use and efficacy as a cessation aid is needed. The study measured the short‑term effects of an electronic nicotine delivery device on desire to smoke, withdrawal symptoms, acceptability, pharmacokinetics, and adverse effects. The single‑blind, randomised, cross‑over trial involved 40 adult smokers who used a 16 mg ENDD, a 0 mg placebo ENDD, a Nicorette inhalator, or their usual cigarette on four study days, with overnight abstinence before each product, and measured serum nicotine levels in a subset of participants. The 16 mg ENDD lowered desire to smoke relative to placebo, was more pleasant and less irritating than the inhalator, and achieved a nicotine peak of 1.3 mg/ml in 19.6 min, comparable to the inhalator but far lower than a cigarette’s 13.4 ng/ml peak. Trial registration No.12607000587404, Australia and New Zealand Clinical Trials Register.

Abstract

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.Single blind randomised repeated measures cross-over trial of the Ruyan V8 ENDD.University research centre in Auckland, New Zealand.40 adult dependent smokers of 10 or more cigarettes per day.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.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.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.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.