Dorothy K Hatsukami1,2, Xianghua Luo1,3, Alisa K Heskin1, Mei Kuen Tang1, Steven G Carmella1, Joni Jensen1, Jason D Robinson4, Ryan Vandrey5, David J Drobes6, Andrew A Strasser7, Mustafa al'Absi8, Scott Leischow9, Paul M Cinciripini4, Joseph Koopmeiners3, Joshua Ikuemonisan1, Neal L Benowitz10, Eric C Donny11, Stephen S Hecht1. 1. Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA. 2. Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA. 3. Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA. 4. Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX, USA. 5. Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA. 6. Moffitt Cancer Center, Department of Health Outcomes and Behavior, Tampa, FL, USA. 7. Department of Psychiatry, Philadelphia, University of Pennsylvania, PA, USA. 8. Behavioral Medicine Laboratories, University of Minnesota Medical School, Duluth, MN, USA. 9. Mayo Clinic, Health Sciences Research, Scottsdale, AZ, USA. 10. Department of Medicine, University of California, San Francisco, CA, USA. 11. Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC, USA.
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.
RCT Entities:
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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