The effects of reduced nicotine content cigarettes on biomarkers of nicotine and toxicant exposure, smoking behavior and psychiatric symptoms in smokers with mood or anxiety disorders: A double-blind randomized trial.

Autor: Foulds J; Penn State Center for Research on Tobacco and Health, Department of Public Health Sciences, Pennsylvania State University-College of Medicine, University Drive, Hershey, PA, United States of America., Veldheer S; Penn State Center for Research on Tobacco and Health, Department of Public Health Sciences, Pennsylvania State University-College of Medicine, University Drive, Hershey, PA, United States of America.; Department of Family and Community Medicine, Penn State College of Medicine, Hershey, PA, United States of America., Pachas G; Center for Addiction Medicine, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States of America.; Harvard Medical School, Boston, MA, United States of America., Hrabovsky S; Penn State Center for Research on Tobacco and Health, Department of Public Health Sciences, Pennsylvania State University-College of Medicine, University Drive, Hershey, PA, United States of America.; Ross and Carol Nese College of Nursing, Penn State University, State College, PA, United States of America., Hameed A; Department of Psychiatry, Pennsylvania State University-College of Medicine, Hershey, PA, United States of America., Allen SI; Penn State Center for Research on Tobacco and Health, Department of Public Health Sciences, Pennsylvania State University-College of Medicine, University Drive, Hershey, PA, United States of America., Cather C; Center for Addiction Medicine, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States of America.; Harvard Medical School, Boston, MA, United States of America., Azzouz N; Center for Addiction Medicine, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States of America.; Harvard Medical School, Boston, MA, United States of America., Yingst J; Penn State Center for Research on Tobacco and Health, Department of Public Health Sciences, Pennsylvania State University-College of Medicine, University Drive, Hershey, PA, United States of America., Hammett E; Penn State Center for Research on Tobacco and Health, Department of Public Health Sciences, Pennsylvania State University-College of Medicine, University Drive, Hershey, PA, United States of America., Modesto J; Penn State Center for Research on Tobacco and Health, Department of Public Health Sciences, Pennsylvania State University-College of Medicine, University Drive, Hershey, PA, United States of America., Krebs NM; Penn State Center for Research on Tobacco and Health, Department of Public Health Sciences, Pennsylvania State University-College of Medicine, University Drive, Hershey, PA, United States of America., Lester C; Penn State Center for Research on Tobacco and Health, Department of Public Health Sciences, Pennsylvania State University-College of Medicine, University Drive, Hershey, PA, United States of America., Trushin N; Penn State Center for Research on Tobacco and Health, Department of Public Health Sciences, Pennsylvania State University-College of Medicine, University Drive, Hershey, PA, United States of America., Reinhart L; Penn State Center for Research on Tobacco and Health, Department of Public Health Sciences, Pennsylvania State University-College of Medicine, University Drive, Hershey, PA, United States of America., Wasserman E; Penn State Center for Research on Tobacco and Health, Department of Public Health Sciences, Pennsylvania State University-College of Medicine, University Drive, Hershey, PA, United States of America., Zhu J; Penn State Center for Research on Tobacco and Health, Department of Public Health Sciences, Pennsylvania State University-College of Medicine, University Drive, Hershey, PA, United States of America., Liao J; Penn State Center for Research on Tobacco and Health, Department of Public Health Sciences, Pennsylvania State University-College of Medicine, University Drive, Hershey, PA, United States of America., Muscat JE; Penn State Center for Research on Tobacco and Health, Department of Public Health Sciences, Pennsylvania State University-College of Medicine, University Drive, Hershey, PA, United States of America., Richie JP Jr; Penn State Center for Research on Tobacco and Health, Department of Public Health Sciences, Pennsylvania State University-College of Medicine, University Drive, Hershey, PA, United States of America., Evins AE; Center for Addiction Medicine, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States of America.; Harvard Medical School, Boston, MA, United States of America.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2022 Nov 02; Vol. 17 (11), pp. e0275522. Date of Electronic Publication: 2022 Nov 02 (Print Publication: 2022).
DOI: 10.1371/journal.pone.0275522
Abstrakt: Background: The U.S. Food and Drug Administration and the government of New Zealand have proposed a reduction of the nicotine content in cigarettes to very low levels. This study examined the potential effects of this regulation in smokers with affective disorders.
Methods: In a randomized controlled parallel group trial conducted at two sites in the USA (Penn State University, Hershey, PA and Massachusetts General Hospital, Boston, MA) 188 adult smokers with a current (n = 118) or lifetime (n = 70) anxiety or unipolar mood disorder, not planning to quit in the next 6 months, were randomly assigned (1:1) to smoke either Usual Nicotine Content (UNC) (11.6 mg nicotine/cigarette) research cigarettes, or Reduced Nicotine Content (RNC) research cigarettes where the nicotine content per cigarette was progressively reduced to 0.2 mg in five steps over 18 weeks. Participants were then offered the choice to either receive assistance to quit smoking, receive free research cigarettes, or resume using their own cigarette brand during a 12-week follow-up period. Main outcomes were biomarkers of nicotine and toxicant exposure, smoking behavior and dependence and severity of psychiatric symptoms. The pre-registered primary outcome was plasma cotinine.
Results: A total of 143 (76.1%) randomized participants completed the randomized phase of the trial, 69 (73.4%) in the RNC group and 74 (78.8%) in the UNC group. After switching to the lowest nicotine content cigarettes, compared to smokers in the UNC group, at the last randomized visit the RNC group had significantly lower plasma cotinine (metabolite of nicotine): difference between groups, -175.7, 95% CI [-218.3, -133.1] ng/ml. Urine NNAL (metabolite of NNK, a lung carcinogen), exhaled carbon-monoxide, cigarette consumption, and cigarette dependence were also significantly lower in the RNC group than the UNC group. No between-group differences were found on a range of other biomarkers (e.g. 8-isoprostanes) or health indicators (e.g. blood pressure), or on 5 different psychiatric questionnaires, including the Kessler K6 measure of psychological distress. At the end of the subsequent 12-week treatment choice phase, those randomized to the RNC group were more likely to have quit smoking, based on initial intent-to-treat sample, n = 188 (18.1% RNC v 4.3% UNC, p = 0.004).
Conclusion: Reducing nicotine content in cigarettes to very low levels reduces some toxicant exposures and cigarette addiction and increases smoking cessation in smokers with mood and/or anxiety disorders, without worsening mental health.
Trial Registration: TRN: NCT01928758, registered August 21, 2013.
Competing Interests: JF has done paid consulting for pharmaceutical companies involved in producing smoking cessation medications, including GSK, Pfizer, Novartis, J&J, and Cypress Bioscience, and received a research grant from Pfizer Inc (not related to reduced nicotine cigarettes). AEE reports grant support to her institution from subcontracts from NIDA grants to Charles River Analytics and Brain Solutions LLC and consulting fees from Karuna Pharmaceuticals and Alkermes and editorial support from Pfizer for papers arising from the EAGLES trial. There are no competing interests to declare for other authors. This does not alter our adherence to PLOS ONE policies on sharing data and materials.
Databáze: MEDLINE
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