• 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, and Eric C Donny.
• Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina; Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina. Electronic address: smithtra@musc.edu.
• Am J Prev Med. 2019 Oct 1; 57 (4): 515524515-524.

IntroductionA 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 DesignA 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/ParticipantsAdult daily smokers (n=240) in the Pittsburgh, PA area.InterventionParticipants 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 MeasuresParticipants 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.ResultsAssignment 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.ConclusionsA 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 RegistrationThis study is registered at www.clinicaltrials.gov NCT02301325.Copyright © 2019 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

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