Reducing nicotine exposure results in weight gain in smokers randomised to very low nicotine content cigarettes

Laura E. Rupprecht, Joe Koopmeiners, Sarah S. Dermody, Jason A. Oliver, Mustafa N al'Absi, Neal L. Benowitz, Rachel Denlinger-Apte, David J. Drobes, Dorothy K Hatsukami, F. Joseph McClernon, Lauren R. Pacek, Tracy T. Smith, Alan F. Sved, Jennifer Tidey, Ryan Vandrey, Eric C. Donny

Research output: Contribution to journalArticle

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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 doubleblind, 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.

Original languageEnglish (US)
Pages (from-to)e43-e48
JournalTobacco control
Volume26
Issue numbere1
DOIs
StatePublished - Jan 1 2017

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Nicotine
Tobacco Products
Weight Gain
nicotine
Group
Tars
Control Groups
United States Food and Drug Administration
Smoke
Action Potentials
smoking
Randomized Controlled Trials
Public Health
public health
Biomarkers
Smoking
Weights and Measures
gender

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Reducing nicotine exposure results in weight gain in smokers randomised to very low nicotine content cigarettes. / Rupprecht, Laura E.; Koopmeiners, Joe; Dermody, Sarah S.; Oliver, Jason A.; al'Absi, Mustafa N; Benowitz, Neal L.; Denlinger-Apte, Rachel; Drobes, David J.; Hatsukami, Dorothy K; McClernon, F. Joseph; Pacek, Lauren R.; Smith, Tracy T.; Sved, Alan F.; Tidey, Jennifer; Vandrey, Ryan; Donny, Eric C.

In: Tobacco control, Vol. 26, No. e1, 01.01.2017, p. e43-e48.

Research output: Contribution to journalArticle

Rupprecht, LE, Koopmeiners, J, Dermody, SS, Oliver, JA, al'Absi, MN, Benowitz, NL, Denlinger-Apte, R, Drobes, DJ, Hatsukami, DK, McClernon, FJ, Pacek, LR, Smith, TT, Sved, AF, Tidey, J, Vandrey, R & Donny, EC 2017, 'Reducing nicotine exposure results in weight gain in smokers randomised to very low nicotine content cigarettes', Tobacco control, vol. 26, no. e1, pp. e43-e48. https://doi.org/10.1136/tobaccocontrol-2016-053301
Rupprecht, Laura E. ; Koopmeiners, Joe ; Dermody, Sarah S. ; Oliver, Jason A. ; al'Absi, Mustafa N ; Benowitz, Neal L. ; Denlinger-Apte, Rachel ; Drobes, David J. ; Hatsukami, Dorothy K ; McClernon, F. Joseph ; Pacek, Lauren R. ; Smith, Tracy T. ; Sved, Alan F. ; Tidey, Jennifer ; Vandrey, Ryan ; Donny, Eric C. / Reducing nicotine exposure results in weight gain in smokers randomised to very low nicotine content cigarettes. In: Tobacco control. 2017 ; Vol. 26, No. e1. pp. e43-e48.
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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 doubleblind, 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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AU - Koopmeiners, Joe

AU - Dermody, Sarah S.

AU - Oliver, Jason A.

AU - al'Absi, Mustafa N

AU - Benowitz, Neal L.

AU - Denlinger-Apte, Rachel

AU - Drobes, David J.

AU - Hatsukami, Dorothy K

AU - McClernon, F. Joseph

AU - Pacek, Lauren R.

AU - Smith, Tracy T.

AU - Sved, Alan F.

AU - Tidey, Jennifer

AU - Vandrey, Ryan

AU - Donny, Eric C.

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N2 - 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 doubleblind, 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.

AB - 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 doubleblind, 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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