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Reducing nicotine exposure results in weight gain in smokers randomised to very low nicotine content cigarettes
  1. Laura E Rupprecht1,
  2. Joseph S Koopmeiners2,
  3. Sarah S Dermody3,
  4. Jason A Oliver4,
  5. Mustafa al'Absi5,
  6. Neal L Benowitz6,7,
  7. Rachel Denlinger-Apte8,
  8. David J Drobes9,
  9. Dorothy Hatsukami10,
  10. F Joseph McClernon4,
  11. Lauren R Pacek4,
  12. Tracy T Smith11,
  13. Alan F Sved1,
  14. Jennifer Tidey8,
  15. Ryan Vandrey12,
  16. Eric C Donny13
  1. 1Center for Neuroscience at the University of Pittsburgh, Pittsburgh, Pennsylvania, USA
  2. 2Division of Biostatistics, School of Public Health at the University of Minnesota, Minneapolis, Minnesota, USA
  3. 3Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada
  4. 4Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina, USA
  5. 5Department of Family Medicine, University of Minnesota Medical School, Duluth, Minnesota, USA
  6. 6Division of Clinical Pharmacology and Experimental Therapeutics, Department of Medicine, University of California, San Francisco, California, USA
  7. 7Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, California, USA
  8. 8Center for Alcohol and Addiction Studies, Brown University, Providence, Rhode Island, USA
  9. 9Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida, USA
  10. 10Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA
  11. 11University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, USA
  12. 12Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
  13. 13Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
  1. Correspondence to Dr Eric C Donny, Department of Psychology, University of Pittsburgh, 4119 Sennott Square 210 S. Bouquet St., Pittsburgh, PA 15260, USA; edonny{at}pitt.edu

Abstract

Background The Food and Drug Administration can reduce the nicotine content in cigarettes to very low levels. This potential regulatory action is hypothesised to improve public health by reducing smoking, but may have unintended consequences related to weight gain.

Methods Weight gain was evaluated from a double-blind, parallel, randomised clinical trial of 839 participants assigned to smoke 1 of 6 investigational cigarettes with nicotine content ranging from 0.4 to 15.8 mg/g or their own usual brand for 6 weeks. Additional analyses evaluated weight gain in the lowest nicotine content cigarette groups (0.4 and 0.4 mg/g, high tar) to examine the effect of study product in compliant participants as assessed by urinary biomarkers. Differences in outcomes due to gender were also explored.

Findings There were no significant differences in weight gain when comparing the reduced nicotine conditions with the 15.8 mg/g control group across all treatment groups and weeks. However, weight gain at week 6 was negatively correlated with nicotine exposure in the 2 lowest nicotine content cigarette conditions. Within the 2 lowest nicotine content cigarette conditions, male and female smokers biochemically verified to be compliant on study product gained significantly more weight than non-compliant smokers and control groups.

Conclusions The effect of random assignment to investigational cigarettes with reduced nicotine on weight gain was likely obscured by non-compliance with study product. Men and women who were compliant in the lowest nicotine content cigarette conditions gained 1.2 kg over 6 weeks, indicating weight gain is a likely consequence of reduced exposure to nicotine.

Trial registration number NCT01681875, Post-results.

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Footnotes

  • Contributors LER and ECD conceptualised the questions and wrote the manuscript. JSK performed final data analyses. JSK, SSD, JAO, MA, NLB, RD-A, DJD, DH, FJM, LRP, TTS, AFS, JTD, RV and ECD designed the study. All authors reviewed and provided feedback on the manuscript.

  • Funding The research reported in this paper was supported by the National Institute on Drug Abuse and the Food and Drug Administration Center for Tobacco Products (U54DA031659). US Department of Health and Human Services, National Institutes of Health.

  • 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 Food and Drug Administration.

  • Competing interests NLB serves as a consultant to several pharmaceutical companies that market smoking cessation medications and has served as a paid expert witness in litigation against tobacco companies.

  • Patient consent Obtained.

  • Ethics approval The study was approved by the Institutional Review Board (IRB) of the respective study sites and monitored by a Data and Safety Monitoring Board. The patient consent is not relevant for this study.

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

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