Short communicationEvaluation of a reduced nicotine product standard: Moderating effects of and impact on cannabis use
Introduction
The Family Smoking Prevention and Tobacco Control Act (FSPTCA; US Congress, 2009) granted the Food and Drug Administration (FDA) the authority to enact product standards that reduce the nicotine content in cigarettes. This reduction is congruent with the hypothesis that reducing the nicotine in cigarettes to a level below an addiction threshold should no longer support dependence, and reduce the public health burden of tobacco (Benowitz and Henningfield, 1994, Benowitz and Henningfield, 2013).
In a 6-week randomized multisite trial (Donny et al., 2015), participants assigned to smoke cigarettes with a nicotine content of 2.4 mg per g of tobacco or lower reported smoking fewer cigarettes per day (CPD) and had decreased biomarkers of nicotine exposure relative to participants who smoked cigarettes with normal nicotine content (NNC; i.e., 15.8 mg/g). Though these findings indicate that VLNC cigarettes may have a positive impact on smokers generally, it remains unknown how reduced nicotine standards would impact smokers who also use cannabis.
Cannabis is the most widely used illicit drug globally; as of 2012, 10.2% and 2.1% of the U.S. population were non-daily and daily users, respectively (Pacek et al., 2015). Cannabis and tobacco are commonly used concurrently: most cannabis users smoke tobacco, and up to half of tobacco smokers use cannabis (Peters et al., 2012). In addition to concurrent use, there is evidence for these substances substituting for one another. Some co-users report increasing tobacco use to cope with withdrawal during cannabis abstinence (Allsop et al., 2014, Levin et al., 2010). Preclinical evidence indicates that THC may reduce nicotine withdrawal (Balerio et al., 2004), suggesting a negative reinforcement pathway that would promote cannabis use during tobacco abstinence. Thus, cannabis users may be differentially impacted by the effects of nicotine reduction on smoking, and reducing nicotine in cigarettes may impact cannabis use.
The present study examines how: (1) baseline cannabis use impacts responses to VLNC cigarettes; and (2) use of VLNC cigarettes impacts cannabis use. We hypothesized that cannabis users would smoke more CPD and experience more withdrawal and craving as a consequence of nicotine reduction. We hypothesized that participants assigned to VLNC cigarettes would be more likely to report cannabis use, and to report using cannabis on a greater proportion of days, as compared to participants assigned to NNC cigarettes, to compensate for the lower nicotine content and manage withdrawal symptoms.
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Participants
Eligible participants (N = 839) were adult, daily smokers who: smoked ≥5 CPD, had expired carbon monoxide (CO) >8 ppm or urine cotinine >100 ng/ml; did not intend to quit smoking in next 30 days, regularly use other tobacco products or binge drink (i.e., >9 of past 30 days), have unstable medical/psychiatric conditions, positive illicit drug toxicology screen other than cannabis, exclusively use “roll your own” cigarettes, and were not pregnant/breastfeeding.
Procedure
Methods for the 7-arm, double-blind, 10-site,
Baseline characteristics of cannabis users versus non-users
At baseline, 28.9% participants were current cannabis users. Of these, 71.5% reported cannabis use and tested positive for THC; 16.4% reported use but tested negative for THC; 12.1% tested positive for THC but did not report use. Current cannabis users self-reported using cannabis on an average of 11.3 days/past month (SD = 11.7). Relative to non- users, cannabis users were more likely to be male χ2 (1, N = 717) = 8.8, p = 0.003; Caucasian χ2 (2, N = 717) = 8.0, p = 0.018; younger t(715) = 10.2, p < 0.001; had
Discussion
Findings indicate that effects of smoking VLNC cigarettes in cannabis users are largely similar to those in non-cannabis users. Cannabis users and non-users experienced reductions in CPD, nicotine dependence, craving, and TNEs. Though differences between cannabis and non-cannabis users were observed on the WISDM, PANAS, and smoking topography during the experimental cigarette period, the lack of significant interactions indicate that baseline cannabis use did not moderate the effect of VLNC
Role of the funding source
Research reported in this publication was supported by the National Institute on Drug Abuse and FDA Center for Tobacco Products (U54 DA031659). Salary support for LRP during the preparation of this paper was provided by T32DA0079209 and T32AI007329. 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. Portions of these data were presented at the College on Problems of Drug Dependence 2015
Conflict of interest
Dr. Drobes reports other support from law firms (on behalf of individual plaintiffs) outside the submitted work, while Dr. McClernon reports previous grant support from Pfizer, Inc., outside the submitted work. Dr. Vandrey reports being a consultant for Zynerba Pharmaceutials outside the submitted work. The authors have no other conflicts of interest to declare.
Contributors
Authors Pacek and Vandrey conceptualized the research question Authors Pacek, Bangdiwala, and Koopmeiners conducted the statistical analyses. Author Pacek wrote the first draft of the manuscript. All authors contributed to, have critically reviewed and revised, and have approved of the final manuscript.
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2022, Preventive MedicineCitation Excerpt :The secondary analysis in 207 cannabis users and 510 non-users found that, at the end of the 6-week intervention, participants in the VLNC condition smoked fewer cigarettes and had lower nicotine exposure and dependence than those in the NNC condition, notwithstanding their cannabis use status (Pacek et al., 2016). Cigarette condition did not affect the prevalence of cannabis use or the proportion of days on which cannabis was used (Pacek et al., 2016). A secondary analysis of the laboratory study by Higgins et al. (2017) found that cannabis use did not moderate the effects of nicotine dose on cigarette reinforcement, although cannabis users rated cigarette satisfaction and craving reduction higher than non-users across doses (Parker et al., 2018).
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2020, Preventive MedicineCitation Excerpt :Reductions in the reinforcing effects of cigarettes has been observed in laboratory studies among youth (Cassidy et al., 2018) and in populations likely to experience health disparities such as persons of lower socioeconomic status, with a diagnosis of substance use disorder, and who experience mental health disorders (Higgins et al., 2017). Regarding potential unintended outcomes of such an approach, reducing nicotine in cigarettes was not associated with changes in depressed mood (Tidey et al., 2017), alcohol (Dermody et al., 2016) or cannabis (Pacek et al., 2016) intake. Weight gain, however, may be experienced in some smokers (Rupprecht et al., 2017), as typically observed when smokers quit smoking.
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