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- Title
Effect of Immediate vs Gradual Reduction in Nicotine Content of Cigarettes on Biomarkers of Smoke Exposure: A Randomized Clinical Trial.
- Authors
Hatsukami, Dorothy K.; Luo, Xianghua; Jensen, Joni A.; al’Absi, Mustafa; Allen, Sharon S.; Carmella, Steven G.; Chen, Menglan; Cinciripini, Paul M.; Denlinger-Apte, Rachel; Drobes, David J.; Koopmeiners, Joseph S.; Lane, Tonya; Le, Chap T.; Leischow, Scott; Luo, Kai; McClernon, F. Joseph; Murphy, Sharon E.; Paiano, Viviana; Robinson, Jason D.; Severson, Herbert
- Abstract
<bold>Importance: </bold>The optimal temporal approach for reducing nicotine to minimally or nonaddictive levels in all cigarettes sold in the United States has not been determined.<bold>Objectives: </bold>To determine the effects of immediate vs gradual reduction in nicotine content to very low levels and as compared with usual nicotine level cigarettes on biomarkers of toxicant exposure.<bold>Design, Setting, and Participants: </bold>A double-blind, randomized, parallel-design study with 2 weeks of baseline smoking and 20 weeks of intervention was conducted at 10 US sites. A volunteer sample of daily smokers with no intention to quit within 30 days was recruited between July 2014 and September 2016, with the last follow-up completed in March 2017.<bold>Interventions: </bold>(1) Immediate reduction to 0.4 mg of nicotine per gram of tobacco cigarettes; (2) gradual reduction from 15.5 mg to 0.4 mg of nicotine per gram of tobacco cigarettes with 5 monthly dose changes; or (3) maintenance on 15.5 mg of nicotine per gram of tobacco cigarettes.<bold>Main Outcomes and Measures: </bold>Between-group differences in 3 co-primary biomarkers of smoke toxicant exposure: breath carbon monoxide (CO), urine 3-hydroxypropylmercapturic acid (3-HPMA, metabolite of acrolein), and urine phenanthrene tetraol (PheT, indicator of polycyclic aromatic hydrocarbons) calculated as area under the concentration-time curve over the 20 weeks of intervention.<bold>Results: </bold>Among 1250 randomized participants (mean age, 45 years; 549 women [44%]; 958 [77%] completed the trial), significantly lower levels of exposure were observed in the immediate vs gradual reduction group for CO (mean difference, -4.06 parts per million [ppm] [95% CI, -4.89 to -3.23]; P < .0055), 3-HPMA (ratio of geometric means, 0.83 [95% CI, 0.77 to 0.88]; P < .0055), and PheT (ratio of geometric means, 0.88 [95% CI, 0.83 to 0.93]; P < .0055). Significantly lower levels of exposure were observed in the immediate reduction vs control group for CO (mean difference, -3.38 [95% CI, -4.40 to -2.36]; P < .0055), 3-HPMA (ratio of geometric means, 0.81 [95% CI, 0.75 to 0.88]; P < .0055), and PheT (ratio of geometric means, 0.86 [95% CI, 0.81 to 0.92]; P < .0055). No significant differences were observed between the gradual reduction vs control groups for CO (mean difference, 0.68 [95% CI, -0.31 to 1.67]; P = .18), 3-HPMA (ratio of geometric means, 0.98 [95% CI, 0.91 to 1.06]; P = .64), and PheT (ratio of geometric means, 0.98 [95% CI, 0.92 to 1.04]; P = .52).<bold>Conclusions and Relevance: </bold>Among smokers, immediate reduction of nicotine in cigarettes led to significantly greater decreases in biomarkers of smoke exposure across time compared with gradual reduction or a control group, with no significant differences between gradual reduction and control.<bold>Trial Registration: </bold>clinicaltrials.gov Identifier: NCT02139930.
- Subjects
CIGARETTES; TOBACCO composition; NICOTINE addiction; PROPAFENONE; NICOTINE addiction treatment; SMOKING cessation; BIOLOGICAL tags; POLYCYCLIC aromatic hydrocarbons; CARBON monoxide analysis; BREATH tests; COMPARATIVE studies; CREATININE; DRUG withdrawal symptoms; HYDROCARBONS; RESEARCH methodology; MEDICAL cooperation; NICOTINE; PHARMACOKINETICS; RESEARCH; RESEARCH funding; SMOKE; SUBSTANCE abuse; TOBACCO; EVALUATION research; TOBACCO products; RANDOMIZED controlled trials; BLIND experiment; ACETYLCYSTEINE
- Publication
JAMA: Journal of the American Medical Association, 2018, Vol 320, Issue 9, p880
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.2018.11473