Effect of Immediate vs Gradual Reduction in Nicotine Content of Cigarettes on Biomarkers of Smoke Exposure

Hatsukami, Dorothy K.; Luo, Xianghua; Jensen, Joni; Al’Absi, Mustafa; Allen, Sharon; Carmella, Steven G.; Chen, Menglan; Cinciripini, Paul M.; Denlinger-Apte, Rachel L.; Drobes, David J.; Koopmeiners, Joseph S.; Lane, Tonya; Le, Chap T.; Leischow, Scott J.; Luo, Kai; McClernon, F. Joseph; Murphy, Sharon E.; Paiano, Viviana; Robinson, Jason D.; Severson, Herbert H.; Sipe, Christopher J.; Strasser, Andrew A.; Strayer, Lori G.; Tang, Man‐Lai; Vandrey, Ryan G.; Hecht, Stephen S.; Benowitz, Neal L.; Donny, Eric C.

doi:10.1001/jama.2018.11473

Cited by 142 publications

(219 citation statements)

References 37 publications

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“…No significant differences were observed for smoking history or demographics across groups. Significantly more dropouts were observed in the immediate reduction condition compared to the other two conditions . When completers ( n = 958) were compared to non‐completers ( n = 292), completers were significantly older [mean (SD) = 46.1 (13.3) versus 41.7 (13.2), P < 0.001]; had more females [ n (%) = 441 (46) versus 108 (37), P = 0.006]; had fewer Hispanics [ n (%) = 38 (4) versus 28 (10), P < 0.001]; had longer duration of smoking [mean (SD) = 28.0 (13.5) versus 23.8 (13.5) years, P < 0.001]; and had fewer who used other tobacco products [number (%) = 168 (21) versus 67 (28), P = 0.018].…”

Section: Resultsmentioning

confidence: 99%

“…When completers ( n = 958) were compared to non‐completers ( n = 292), completers were significantly older [mean (SD) = 46.1 (13.3) versus 41.7 (13.2), P < 0.001]; had more females [ n (%) = 441 (46) versus 108 (37), P = 0.006]; had fewer Hispanics [ n (%) = 38 (4) versus 28 (10), P < 0.001]; had longer duration of smoking [mean (SD) = 28.0 (13.5) versus 23.8 (13.5) years, P < 0.001]; and had fewer who used other tobacco products [number (%) = 168 (21) versus 67 (28), P = 0.018]. See Hatsukami et al ., eTable 11 .…”

Section: Resultsmentioning

confidence: 99%

“…Overall, the results from this study demonstrate that although significant reductions occur in cigarettes per day and biomarkers of exposure with reduced nicotine content cigarettes , these cigarettes might still be associated with significant health risks related to harmful chemical exposure. Reductions in biomarkers of exposure (e.g.…”

Section: Discussionmentioning

confidence: 99%

“…In prior studies, significant reductions in biomarkers of exposure to harmful tobacco and smoke constituents (e.g. tobacco‐specific nitrosamines, volatile organic compounds) were observed when smokers who were assigned to immediate reduction to very low nicotine content (VLNC) cigarettes were compared to smokers assigned to gradual nicotine reduction or normal nicotine content cigarettes . This reduction in biomarkers of exposure was due largely to the reduction in cigarettes per day observed in the immediate reduction condition.…”

Section: Introductionmentioning

confidence: 98%

“…The goal of this study was to examine biomarkers of inflammation, oxidative stress and hematological parameters that were analyzed from a large clinical trial , comparing smokers who underwent immediate versus gradual nicotine reduction in cigarettes; both of these conditions were compared to the control group who smoked normal nicotine content cigarettes. Prostaglandin E 2 metabolite (PGEM) and ( Z )‐7‐[1 R , 2 R, 3R , 5 S ]‐3,5‐dihydroxy‐2‐[( E ,3 S )‐3‐hydroxyoct‐1‐enyl]cyclopentyl]hept‐5‐enoic acid) (8‐ iso‐ PGF 2α ) are established biomarkers of oxidative damage and inflammation, respectively.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2019

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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.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 98%

Section: Introductionmentioning

confidence: 99%

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

et al. 2019

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Changes in Cigarette Consumption With Reduced Nicotine Content Cigarettes Among Smokers With Psychiatric Conditions or Socioeconomic Disadvantage

et al. 2020

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Clinical Pharmacology of Electronic Nicotine Delivery Systems (ENDS): Implications for Benefits and Risks in the Promotion of the Combusted Tobacco Endgame

Benowitz

Helen

Liakoni

2021

The Journal of Clinical Pharma

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Electronic nicotine delivery systems (ENDS) such as e‐cigarettes and heated tobacco products are novel battery‐operated devices that deliver nicotine without combustion of tobacco. Because cigarette smoking is sustained by nicotine addiction and the toxic combustion products are mainly responsible for the harmful effects of smoking, ENDS could be used to promote smoking cessation while exposing users to lower levels of toxicants compared with conventional cigarettes. The currently available evidence from clinical and observational studies indicates a potential role of e‐cigarettes as smoking cessation aids, although many continue to use e‐cigarettes long after quitting smoking. Nicotine and toxicant delivery vary considerably by device and depend on the characteristics of the e‐liquid formulation. Because smokers tend to titrate their nicotine intake to maintain their desired pharmacologic effects, device and liquid characteristics need to be considered when using ENDS as an aid to quit smoking. Factors potentially limiting their use are the currently still unknown long‐term safety of these products and concerns regarding widespread use among youth. Implications of clinical pharmacology data on ENDS for the cigarette endgame and regulation by the U.S. Food and Drug administration are discussed.

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Effect of Immediate vs Gradual Reduction in Nicotine Content of Cigarettes on Biomarkers of Smoke Exposure

Abstract: clinicaltrials.gov Identifier: NCT02139930.

Cited by 142 publications

References 37 publications

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

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

Changes in Cigarette Consumption With Reduced Nicotine Content Cigarettes Among Smokers With Psychiatric Conditions or Socioeconomic Disadvantage

Clinical Pharmacology of Electronic Nicotine Delivery Systems (ENDS): Implications for Benefits and Risks in the Promotion of the Combusted Tobacco Endgame

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