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

Abstract

Background The Food and Drug Administration can reduce the nicotine content in cigarettes to very low levels. This potential regulatory action is hypothesized 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, randomized clinical trial of 839 participants assigned to smoke one of six investigational cigarettes with nicotine content ranging from 0.4 mg/g to 15.8 mg/g or their own usual brand for six weeks. Additional analyses evaluated weight gain in the lowest nicotine content cigarette groups (0.4 mg/g and 0.4 mg/g, high tar) to examine effect of study product in compliant subjects 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 two lowest nicotine content cigarette conditions. Within the two lowest nicotine content cigarette conditions, both 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 six weeks, indicating weight gain is a likely consequence of reduced exposure to nicotine.

Nicotine Reduction in Cigarettes: Literature Review and Gap Analysis

“…Despite the reduction in smoking-related biomarkers of harm, other studies noted that moving current smokers to VLNCs could negatively impact cognitive function and memory 17–19 and could potentially prompt weight gain. 29 These studies suggest the possibility of harmful unintended effects if current smokers do not have access to other, less harmful sources of nicotine when a nicotine reduction product standard takes effect.…”

Conflicts and controversies in contemporary tobacco control

“…Donny et al ,10 arguing that reduced nicotine cigarettes should be tried in New Zealand, respond to common questions about this approach. However, as Rupprecht et al report,11 weight gain may be a likely consequence of reduced nicotine exposure, similar to that associated with quitting smoking. No government has yet undertaken mandatory nicotine reduction, and the regulatory and enforcement costs associated with such a step will likely limit its chances to high-income countries in the near term.…”

Animal Research on Nicotine Reduction: Current Evidence and Research Gaps

“…68 In a recent clinical trial, individuals with low biomarkers of nicotine exposure (indicating compliance with the study product) gained weight over the course of the trial, but individuals with higher biomarkers of nicotine exposure did not, suggesting that nicotine reduction produces weight gain in individuals who are compliant with the study product. 99 Indeed, in rats, a reduction in nicotine dose below the threshold for maintaining self-administration behavior produces significant increases in weight gain compared to those maintained on a high standard dose of nicotine. 100 However, VLNC cigarettes may still suppress weight gain compared to abstaining from smoking in individuals who try smoking for the first time following implementation of a nicotine reduction policy.…”