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Original research
Effects of liquid nicotine concentration and flavour on the acceptability of electronic nicotine delivery systems (ENDS) among people who smoke participating in a randomised controlled trial to reduce cigarette consumption
  1. Jessica Yingst1,
  2. Vishal Midya2,
  3. Augustus White3,
  4. Jonathan Foulds1,
  5. Caroline O Cobb4,
  6. Susan Veldheer5,
  7. Miao-Shan Yen6,
  8. Thomas Eissenberg4
  1. 1Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania, USA
  2. 2Department of Environmental Medicine and Public Health, Icahn School of Medicine, New York, New York, USA
  3. 3Department of Health Behavior and Policy, Virginia Commonwealth University, Richmond, Virginia, USA
  4. 4Department of Psychology, Virginia Commonwealth University, Richmond, Virginia, USA
  5. 5Departmanrt of Family and Community Medicine, Penn State College of Medicine, Hershey, Pennsylvania, USA
  6. 6Department of Biostatistics, Virginia Commonwealth University, Richmond, Virginia, USA
  1. Correspondence to Dr. Jessica Yingst, Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania, USA; jyingst{at}pennstatehealth.psu.edu

Abstract

Background Research is needed to understand the acceptability of electronic nicotine delivery systems (ENDS) as a smoking reduction aid. This study examines the acceptability of ENDS by liquid nicotine concentration and flavour among people who smoke using ENDS to reduce their smoking.

Methods People who smoke cigarettes but were naïve to ENDS participated in a double-blind randomised controlled trial to reduce conventional cigarette smoking. Participants were randomised to either a control cigarette substitute (CS) or one of three ENDS groups; 0 mg/mL, 8 mg/mL or 36 mg/mL nicotine concentration. ENDS flavour was chosen by the participant (tobacco or menthol). Participants reported their CS, ENDS and cigarettes per day (CPD) from the past 7 days at 1-month, 3-month and 6-month follow-up visits. Participants also reported side effects and measures of satisfaction, psychological reward, aversion and craving relief. Outcome variables were modelled using linear mixed effects by the following groups: liquid nicotine concentration, flavour and a flavour-nicotine concentration interaction.

Results Participants (n=520) were 41.2% male, 67.3% white, had a mean age of 46.2 years and smoked a mean of 18.6 CPD (SD=7.74) at baseline. All flavour and concentration groups decreased CPD from baseline to all follow-up visits with the 36 mg/mL experiencing the greatest reduction, compared with the 0 mg/mL and 8 mg/mL groups. All groups except the 36 mg/mL group decreased their product use over time. The use of menthol flavour was associated with fewer side effects at 3 months (p=0.02) and lesser aversion at 1 month (p=0.03) compared with tobacco-flavoured ENDS. The 36 mg/mL group experienced the greatest craving relief and greatest aversion compared with other groups.

Conclusions Both nicotine concentration and flavour appear to have independent, as well as interactive, effects that influence ENDS acceptability among people who use cigarettes.

  • Nicotine
  • Electronic nicotine delivery devices
  • Harm Reduction

Data availability statement

Data are available on reasonable request. On publication, requests for deidentified individual participant data or study documents (eg, data dictionary; protocol; statistical analysis plan; measures, manuals or informed consent documentation) will be considered. The requestor must submit a one-page abstract of their proposed research, including the purpose, analytical plan and dissemination plans. The Executive Leadership Committee (Virginia Commonwealth University and Penn State University) will review the abstract and decide on the basis of the individual merits. Review criteria and prioritisation of projects include potential of the proposed work to advance public health, qualifications of the applicant, the potential for publication, the potential for future funding, and enhancing the scientific, geographic and demographic diversity of the research portfolio. Following abstract approval, requestors must receive institutional ethics approval or confirmation of exempt status for the proposed research. An executed data use agreement must be completed before data distribution. Requests should be made to the corresponding author.

https://doi.org/10.1136/tc-2023-058282

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    Data availability statement

    Data are available on reasonable request. On publication, requests for deidentified individual participant data or study documents (eg, data dictionary; protocol; statistical analysis plan; measures, manuals or informed consent documentation) will be considered. The requestor must submit a one-page abstract of their proposed research, including the purpose, analytical plan and dissemination plans. The Executive Leadership Committee (Virginia Commonwealth University and Penn State University) will review the abstract and decide on the basis of the individual merits. Review criteria and prioritisation of projects include potential of the proposed work to advance public health, qualifications of the applicant, the potential for publication, the potential for future funding, and enhancing the scientific, geographic and demographic diversity of the research portfolio. Following abstract approval, requestors must receive institutional ethics approval or confirmation of exempt status for the proposed research. An executed data use agreement must be completed before data distribution. Requests should be made to the corresponding author.

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    Footnotes

    • Contributors JY: conceptualisation, methodology, investigation, data curation, writing-original draft, writing-review and editing, guarantor. VM: formal analysis, writing-review and editing. AW: writing-review and editing. JF: conceptualisation, methodology, writing-review and editing, funding acquisition, supervision. COC: investigation, data curation, writing-review and editing. SV: investigation, data curation, writing-review and editing. M-SY: formal analysis, writing-review and editing. TE: conceptualisation, methodology, writing-review and editing, funding acquisition, supervision.

    • Funding This study was supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number P50DA036105 and U54DA36105 and the Center for Tobacco Products of the US Food and Drug Administration. JY, JF and SV were also supported by the National Institutes of Health (NIH) and the National Institute of Drug Abuse under Award Number P50DA036107. AW is primarily supported by the National Institutes of Health (NIH) and National Institute of Drug Abuse (NIDA) the under award number F30DA057047.

    • Disclaimer The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the Food and Drug Administration.

    • Competing interests JF has done paid consulting for pharmaceutical companies involved in producing smoking cessation medications, including GSK, Pfizer, Novartis, J&J and Cypress Bioscience. TE is a paid consultant in litigation against the tobacco industry and also the electronic cigarette industry and is named on one patent for a device that measures the puffing behaviour of electronic cigarette users, on another patent application for a smartphone app that determines electronic cigarette device and liquid characteristics, and a third patent application for a smoking cessation intervention. There are no other competing interests to report for other authors.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.