Abstract
Rationale
The Food and Drug Administration is considering severely restricting the nicotine in cigarettes, to reduce smoking. A study showed that non-daily, intermittent smokers (ITS) randomized to very-low-nicotine-content cigarettes (VLNCCs) reduced their cigarette consumption.
Objectives
To assess whether increased smoking intensity of VLNCCs compensated for some of the reduced cigarette consumption.
Methods
After a 2-week baseline smoking their own-brand cigarettes, 118 ITS were randomized to VLNCCs (~ 1 mg nicotine/g tobacco), and 120 to normal-nicotine-content cigarettes (NNCCs; ~ 16 mg/g) for 10 weeks. Laboratory measures of smoking intensity—total puff volume and carbon monoxide (CO) boost—assessed single cigarettes smoked in up to three laboratory topography sessions. Field measures assessed returned cigarette butts, averaged over up to five 2-week intervals: the mass of tobacco burned (computed from residual mass of butts) and the intensity of smoking (by scanning of returned filters). Analysis was by mixed model random effects models using baseline values as covariates.
Results
ITS in the VLNCC group puffed less smoke in topography sessions (−38.50 mL [−75.21, −1.78]; p < 0.04), but showed no difference in CO boost. Participants in the VLNCC group burned 0.02 [0.04, 0.002] grams less tobacco per cigarette (p < 0.03). Analysis of filters showed their smoking intensity declined over time, compared to NNCC participants (p < 0.04). “Cheating” by smoking normal cigarettes did not moderate these effects.
Conclusions
ITS did not increase their smoking intensity when switched to VLNCCs; indeed, their smoking intensity decreased. Reductions in cigarette consumption seen when ITS are switched to VLNCCs were not compensated by increased smoking intensity.
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Acknowledgements
The authors are grateful to Allison Brown for the assistance overseeing the study, to David Colarusso, Corinne Hogge, and Ian Jutsum, research assistants who conducted research sessions, to James Moorehead for the data management and preparation, to Alexsys Hoesch for the administrative assistance, to Dr. Esa Davis for the medical oversight, and to Dr. Clifford Watson for providing the filter-scanning software and training and consultation on the scanning. We also appreciate the contributions of members of the study Data and Safety Monitoring Board, Peter Callas (University of Vermont), Matthew Carpenter (Medical University of South Carolina), Jonathan Foulds (Pennsylvania State University), and John Hughes (University of Vermont).
Funding
This work was supported by a grant (S. Shiffman) from the National Cancer Institute (NCI) at the National Institutes of Health (NIH) and the Center for Tobacco Products (CTP) at the Food and Drug Administration (FDA), awarded as a supplement to grant number P30CA047904. The grant supported use of the UPMC Hillman Cancer Center Biostatistics Shared Resource Facility.
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The study was approved by the University of Pittsburgh Institutional Review Board and participants provided written informed consent.
Conflict of interest
SS, through Pinney Associates, consults on tobacco cessation and harm reduction (including nicotine replacement therapy and digital vapor products; by contract, combusted cigarettes are excluded) to Niconovum USA, RJ Reynolds Vapor Company, and RAI Services Company, all subsidiaries of Reynolds American, Inc. and British American Tobacco. Previously, SS consulted to NJOY on e-cigarettes, and to GlaxoSmithKline Consumer Healthcare on smoking cessation medications and treatments. SS holds patents for a novel nicotine smoking cessation medication that is not under commercial development. Other authors report no competing interests.
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NCI and FDA, had no role in design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the FDA.
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Shiffman, S., Mao, J.M., Kurland, B.F. et al. Do non-daily smokers compensate for reduced cigarette consumption when smoking very-low-nicotine-content cigarettes?. Psychopharmacology 235, 3435–3441 (2018). https://doi.org/10.1007/s00213-018-5056-8
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DOI: https://doi.org/10.1007/s00213-018-5056-8