Randomized Trial of Low-Nicotine Cigarettes and Transdermal Nicotine

Tracy T. Smith, Joseph S. Koopmeiners, Katelyn M. Tessier, Esa M. Davis, Cynthia A. Conklin, Rachel L. Denlinger-Apte, Tonya Lane, Sharon E. Murphy, Jennifer W. Tidey, Dorothy K. Hatsukami, Eric C. Donny

Research output: Contribution to journalArticlepeer-review

8 Scopus citations

Abstract

Introduction: A mandated reduction in the nicotine content of cigarettes may decrease smoking, but also increase demand for other nicotine products. The present study tested the impact of smoking cigarettes with very low nicotine content and concurrent use of a transdermal nicotine patch. Study design: A balanced 2 × 2 factorial randomized clinical trial investigating the impact of cigarette nicotine content (double-blind, very low nicotine content versus normal nicotine content) and use of a transdermal nicotine patch (open label, patch versus no patch). Setting/participants: Adult daily smokers (n=240) in the Pittsburgh, PA area. Intervention: Participants were provided with research cigarettes and transdermal nicotine patches (if assigned to patch condition) for 7 weeks. Cigarettes were Spectrum brand (National Institute on Drug Abuse) and either 15.8 mg nicotine/g tobacco (normal nicotine content) or 0.4 mg nicotine/g tobacco (very low nicotine content). In the 7th week, participants were monetarily incentivized to abstain from smoking. Main outcome measures: Participants reported daily cigarette use throughout the trial and the primary outcome was average number of cigarettes smoked per day (study + nonstudy) during Week 6. Participants were recruited from 2015 to 2017 and data were analyzed between 2017 and 2018. Results: Assignment to very low nicotine content cigarettes and assignment to wear a nicotine patch both reduced the number of cigarettes smoked per day during Week 6 (p=0.001 and 0.04, respectively). However, assignment to the patch along with very low nicotine content cigarettes did not significantly reduce cigarette smoking compared with assignment to very low nicotine content cigarettes alone. Conclusions: A mandated reduction in the nicotine content of cigarettes is likely to reduce the number of cigarettes smoked per day, but the added benefit of concurrent transdermal nicotine is unclear. Future studies should investigate whether alternative sources of noncombusted tobacco, such as e-cigarettes, enhance the effects of very low nicotine content cigarettes on smoking. Trial registration: This study is registered at www.clinicaltrials.gov NCT02301325.

Original languageEnglish (US)
Pages (from-to)515-524
Number of pages10
JournalAmerican journal of preventive medicine
Volume57
Issue number4
DOIs
StatePublished - Oct 2019

Bibliographical note

Funding Information:
Research reported in this publication was supported by the National Institute on Drug Abuse and U.S. Food and Drug Administration Center for Tobacco Products ( U54 DA031659 awarded to ECD and DKH). Research reported in this publication was also supported by NIH grant P30 CA77598 utilizing the Biostatistics and Bioinformatics Core shared resource of the Masonic Cancer Center, University of Minnesota; and by the National Center for Advancing Translational Sciences of the NIH, award number UL1TR000114.

Funding Information:
We thank Dr. Brian Primack who served as a licensed medical professional on the trial and provided partial review of eligibility and adverse events, and Dr. Michelle Levine who served as a licensed clinical psychologist on the trial. We thank all the staff involved with data collection, including Cathy Scott, Erin Goldstein, Guy Agostinelli, Lee Bennett, Ravi Choudhuri, Samantha Cwalina, Vanessa Fishel, John Mahalchak, Maura Matvey, Jamie Pearson, Patricia Schademan, Michael Tommarello, and Kristin Yahner. We thank Nicole Thompson for carrying out the anatabine and total nicotine equivalent analyses. Research reported in this publication was supported by the National Institute on Drug Abuse and U.S. Food and Drug Administration Center for Tobacco Products (U54 DA031659 awarded to ECD and DKH). Research reported in this publication was also supported by NIH grant P30 CA77598 utilizing the Biostatistics and Bioinformatics Core shared resource of the Masonic Cancer Center, University of Minnesota; and by the National Center for Advancing Translational Sciences of the NIH, award number UL1TR000114. The funding source had no role other than financial support. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the Food and Drug Administration. The authors declare no other conflicts of interest. All authors contributed to study design and study protocol. TTS wrote the initial draft of the manuscript. JSK was the lead statistician and analyzed the data with KT. SEM analyzed the urinary biomarkers. All authors contributed to the final submitted manuscript. No financial disclosures were reported by the authors of this paper.

Publisher Copyright:
© 2019 American Journal of Preventive Medicine

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