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Tob Control. 2017 Mar;26(e1):e43-e48. doi: 10.1136/tobaccocontrol-2016-053301. Epub 2016 Nov 17.

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

Author information

1
Center for Neuroscience at the University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
2
Division of Biostatistics, School of Public Health at the University of Minnesota, Minneapolis, Minnesota, USA.
3
Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.
4
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina, USA.
5
Department of Family Medicine, University of Minnesota Medical School, Duluth, Minnesota, USA.
6
Division of Clinical Pharmacology and Experimental Therapeutics, Department of Medicine, University of California, San Francisco, California, USA.
7
Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, California, USA.
8
Center for Alcohol and Addiction Studies, Brown University, Providence, Rhode Island, USA.
9
Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida, USA.
10
Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.
11
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, USA.
12
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
13
Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.

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.

KEYWORDS:

Harm Reduction; Nicotine; Public policy

[Indexed for MEDLINE]
Free PMC Article

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