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.
- Harm Reduction
- Public policy
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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.