Effects of immediate versus gradual nicotine reduction in cigarettes on biomarkers of biological effects.

Dorothy K Hatsukami, Xianghua Luo, Alisa K Heskin, Mei Kuen Tang, Steven G Carmella, Joni Jensen, Jason D Robinson, Ryan Vandrey, David J Drobes, Andrew A Strasser, Mustafa al'Absi, Scott Leischow, Paul M Cinciripini, Joseph Koopmeiners, Joshua Ikuemonisan, Neal L Benowitz, Eric C Donny, Stephen S Hecht

Journal: Addiction (Abingdon, England) 2020;114(10):1824-1833

PMID: 31140663

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Abstract

AIM

A previous study showed significantly greater reductions in number of cigarettes smoked and biomarkers of toxicant and carcinogen exposure in smokers assigned to immediate reduction of nicotine in cigarettes to very low levels versus gradually over time or continued smoking of normal nicotine content cigarettes. This study examines the effects of these approaches on selected biomarkers associated with harmful biological effects.

DESIGN

Three-arm, randomized controlled trial.

SETTING

Ten United States academic institutional sites.

PARTICIPANTS

Daily smokers uninterested in quitting smoking with a mean age of 45.1 [standard deviation (SD) = 13.4)] years and smoking 17.1 (SD = 8.5) cigarettes/day; 43.9% (549 of 1250) female; 60.6% (758 of 1250) white ethnicity.

INTERVENTIONS

(1) Smoking cigarettes where nicotine content was immediately reduced to very low levels (n = 503); (2) smoking cigarettes where nicotine content was gradually reduced, with dose changes occurring monthly (n = 498); and (3) continued smoking with normal nicotine content cigarettes (n = 249).

MEASUREMENTS

Smokers were assessed at baseline while smoking their usual brand cigarettes, and again at 4, 8, 12, 16 and 20 weeks. Outcomes were areas under the concentration time curve (AUC) for the period of study of biomarkers of inflammation, oxidative stress and hematological parameters.

FINDINGS

No consistent significant differences were observed across groups (Bayes factors showing data to be insensitive), with the only exception being red blood cell size variability, which was observed to be lower in the immediate versus gradual nicotine reduction [mean difference = -0.11; 95% confidence interval (CI) = -0.18, -0.04, P = 0.004] and normal nicotine control groups (mean difference = - 0.15, 95% CI = -0.23, -0.06, P = 0.001).

CONCLUSION

It remains unclear whether switching to very low nicotine cigarettes leads to a short-term reduction in biomarkers of tobacco-related harm.

Address: Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.; Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.; Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.; Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.; Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.; Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX, USA.; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA.; Moffitt Cancer Center, Department of Health Outcomes and Behavior, Tampa, FL, USA.; Department of Psychiatry, Philadelphia, University of Pennsylvania, PA, USA.; Behavioral Medicine Laboratories, University of Minnesota Medical School, Duluth, MN, USA.; Mayo Clinic, Health Sciences Research, Scottsdale, AZ, USA.; Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.; Department of Medicine, University of California, San Francisco, CA, USA.; Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC, USA.

DOI: 10.1111/add.14695

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MeSH Terms: Adult, Bayes Theorem, Biomarkers, C-Reactive Protein, Cigarette Smoking, Dinoprost, Dinoprostone, Erythrocyte Count, Erythrocyte Indices, Female, Humans, Inflammation, Leukocyte Count, Male, Middle Aged, Nicotine, Nicotinic Agonists, Oxidative Stress, Platelet Count, Smoking Reduction, Tobacco Products