Tracy T Smith1, Joseph S Koopmeiners2, Katelyn M Tessier3, Esa M Davis4, Cynthia A Conklin5, Rachel L Denlinger-Apte6, Tonya Lane3, Sharon E Murphy7, Jennifer W Tidey6, Dorothy K Hatsukami8, Eric C Donny9. 1. 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. 2. Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota; Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota. 3. Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota. 4. Department of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania. 5. Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania. 6. Department of Behavioral and Social Sciences, Brown School of Public Health, Brown University, Providence, Rhode Island. 7. Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota; Department of Biochemistry Molecular Biology and BioPhysics, University of Minnesota, Minneapolis, Minnesota. 8. Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota; Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota. 9. Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, North Carolina.
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.
RCT Entities:
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.
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