1. The Impact of Exclusive Use of Very Low Nicotine Cigarettes on Compensatory Smoking: An Inpatient Crossover Clinical Trial
- Author
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Smith, Tracy T, Koopmeiners, Joseph S, White, Cassidy M, Denlinger-Apte, Rachel L, Pacek, Lauren R, De Jesús, Víctor R, Wang, Lanqing, Watson, Clifford, Blount, Benjamin C, Hatsukami, Dorothy K, Benowitz, Neal L, Donny, Eric C, and Carpenter, Matthew J
- Subjects
Substance Misuse ,Brain Disorders ,Tobacco ,Drug Abuse (NIDA only) ,Clinical Trials and Supportive Activities ,Clinical Research ,Prevention ,Tobacco Smoke and Health ,Cancer ,Respiratory ,Good Health and Well Being ,Adult ,Cigarette Smoking ,Cross-Over Studies ,Female ,Humans ,Male ,Middle Aged ,Nicotine ,Smokers ,Smoking Cessation ,Tobacco Products ,Medical and Health Sciences ,Epidemiology - Abstract
BackgroundThe FDA is considering a mandated reduction in the nicotine content of cigarettes. Clinical trials have been limited by non-study cigarette use (noncompliance), which could mask compensation. The goal of this study was to assess whether compensation occurs when smokers provided with very low nicotine cigarettes cannot access normal nicotine cigarettes.MethodsIn a within-subjects, crossover design, current smokers (n = 16) were confined to a hotel for two 4-night hotel stays during which they were only able to access the research cigarettes provided. The hotel stays offered normal nicotine cigarettes or very low nicotine content (VLNC) cigarettes, in an unblinded design, available for "purchase" via a study bank.ResultsIn the context of complete compliance with the study cigarettes (n = 16), there was not a significant increase during the VLNC condition for cigarettes smoked per day, expired carbon monoxide, or N-acetyl-S-(cyanoethyl)-l-cysteine (cyanoethyl-MA, metabolite of acrylonitrile). There was a significant nicotine × time interaction on urine N-acetyl-S-(3-hydroxypropyl)-l-cysteine (hydroxypropyl-MA, metabolite of acrolein), driven by an increase in the VLNC condition during the first 24 hours. By the end of the VLNC condition, there was no evidence of compensation across any measure of smoking or smoke exposure.ConclusionsAmong current smokers who exclusively used VLNC cigarettes for 4 days, there was no significant compensatory smoking behavior.ImpactThese data, combined with the larger body of work, suggest that a mandated reduction in nicotine content is unlikely to result in an increase in smoking behavior to obtain more nicotine.
- Published
- 2020