Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial
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
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Nicotine delivery varies across electronic cigarette devices and users.
“While there is evidence of variability in nicotine delivery across devices and users,(311, 312)”
From Developmental toxicity of nicotine: A transdisciplinary synthesis and implications for emerging tobacco products (2017) · cites this paper as [312]
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“and there is a lack of internationally certified manufacturing sites. Regulators also lack data on the ability of ENDDs to relieve the desire to smoke cigarettes and to suppress other tobacco withdrawal symptoms. Study designs that assess change in subjective withdrawal symptoms have been used to evaluate the utility…”
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- Authors
- Bullen, C., McRobbie, H., Thornley, S., Glover, M., Lin, R., & Laugesen, M.
- Affiliations
- University of Auckland (NZ)
- University of London (GB)
- Covance (Australia) (AU)
- Health New Zealand (NZ)
- Corresponding author
- Bullen, C
- Venue
- Tobacco Control
- Publisher
- BMJ
- Published
- 2010-04
- Volume
- 19
- Issue
- 2
- Pages
- 98-103
- ISSN
- 0964-4563 (ISSN-L)
- 1468-3318
- OpenAlex
- W2096533285
- Cited by
- 515
- References
- 4
- Citations by year
- 2026: 5 · 2025: 14 · 2024: 12 · 2023: 9 · 2022: 16 · 2021: 23 · 2020: 23 · 2019: 36 · 2018: 37 · 2017: 33 · 2016: 55 · 2015: 61 · 2014: 88 · 2013: 45 · 2012: 25
- FWCI
- 22.32
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Tobacco Control (publishedVersion)
- PubMed (publishedVersion)
- ResearchSpace (University of Auckland) (submittedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Inhalation and Respiratory Drug Delivery
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Keywords
- electronic cigarettes, nicotine withdrawal symptoms, nicotine pharmacokinetics, smoking cessation aids, nicotine dose, product acceptance, adverse effects, nicotine dependence
- MeSH terms
- Administration, Inhalation, Adult, Consumer Behavior, Data Interpretation, Statistical, Electrons, Female, Humans, Irritants, Male, Middle Aged, Nicotine, Smoking, Substance Withdrawal Syndrome, Multivariate Analysis, Drug Delivery Systems, Smoking Cessation, Treatment Outcome, Cross-Over Studies, Nicotinic Agonists
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