Abstract
Cigars are available in a variety of flavors that may impact uptake and use, but little is known about how different flavors affect abuse liability. This study used three behavioral economic tasks to examine abuse liability of Black & Mild cigars differing in flavor among young adult cigarette smokers. Participants were 25 cigar-naïve young adults (ages 18–25) who smoked ≥5 cigarettes/day. In five Latin square-ordered laboratory visits, participants completed three abuse liability tasks (drug purchase task, cross-price purchase task, and multiple choice procedure) for each of four cigar flavors (original, cream, wine, or apple) and own brand cigarettes. In the drug purchase task, relative to own brand cigarettes, all cigar flavors were associated with lower abuse liability using most measures (intensity, breakpoint, Omax (ps<0.05)), although only wine-flavored cigars scored significantly lower using one measure (Pmax). When cigars and cigarettes were available concurrently in the cross-price purchase task, all cigar flavors functioned as substitutes for cigarettes. Using the multiple choice procedure, crossover points for wine- (mean $0.61) and apple-flavored cigars (mean $0.71) were significantly lower than own brand cigarettes (mean $0.86) and original-flavored cigars (mean $1.00); no significant differences existed between own brand cigarettes and original-flavored cigars. Thus, while abuse liability may be highest for participants’ own brand cigarette, young adult smokers may be willing to use flavored cigars. Further, abuse liability varies by cigar flavor, with original- and cream-flavored cigars appearing to have the highest abuse liability. Characterizing flavors and flavor additives in cigars represent an important tobacco regulatory target.
Keywords: cigars, young adults, flavors, abuse liability, tobacco
Introduction
As of 2018, over 9.5 million United States (US) adults smoked tobacco cigars, including large cigars, little cigars, and cigarillos (Creamer et al., 2019). Cigar use is linked to considerable morbidity and mortality (Nonnemaker, Rostron, Hall, MacMonegle, & Apelberg, 2014; Rostron, Corey, & Gindi, 2019), making policies, regulations, and programs that prevent initiation and promote cessation of cigar use critical for public health. One important regulatory target is the availability of flavors in cigars. Characterizing flavors (e.g., strawberry, vanilla) can increase cigars’ appeal (Sterling, Fryer, Nix, & Fagan, 2015) and are associated with higher likelihood of cigar initiation and use (Villanti et al., 2019) and lower intentions to quit (King, Tynan, Dube, & Arrazola, 2014). Such flavors appear particularly appealing to youth and young adults (Delnevo, Giovenco, Ambrose, Corey, & Conway, 2015). While federal regulations banned non-menthol characterizing flavors in cigarettes as of 2009 (Family Smoking and Tobacco Control Act, 2009) and in cartridge or pod-type electronic nicotine delivery devices as of 2020 (Food & Drug Administration, 2020), these regulations currently do not apply to other tobacco products, despite interest in similar regulations for cigars (Food & Drug Administration, 2018).
Understanding which product characteristics are associated with greater abuse liability for cigars is essential for developing policies, regulations and product standards that promote public health. Abuse liability refers to the likelihood of a drug to be used non-medically and for its use to lead to dependence (Carter et al., 2009) and may be influenced by characteristics of the drug or drug delivery system, the individual user, and the social and policy environment. Several indices of abuse liability can be measured in the clinical laboratory, a setting that allows for efficient and controlled examination of subjective, physiological, and behavioral responses to the drug (Wall et al., 2018). However, few studies have examined abuse liability for cigars in the clinical laboratory (Blank, Cobb, Eissenberg, & Nasim, 2016; Blank, Nasim, Hart, & Eissenberg, 2011; Fabian, Canlas, Potts, & Pickworth, 2012), and none to our knowledge have examined the role of cigar flavors. Different cigar flavors may have different toxicity profiles (Lawyer et al., 2019) and abuse liability profiles, as flavors can enhance subjective experiences including taste and throat hit and influence smoke inhalation and nicotine yield (Goel et al., 2018; Kostygina, Glantz, & Ling, 2014).
In this study, we examine behavioral indices of abuse liability for different flavors of cigars among young adult cigarette smokers. We focus on Black & Mild, a brand which as of 2015 represented the largest market share among cigars sold in US convenience stores and which offers cigars in the four leading flavor categories: unflavored, fruit, sweet/candy and wine (Delnevo, Giovenco, & Miller Lo, 2017).
Methods
Participants
Participants were 25 combustible tobacco cigarette smokers aged 18–25 years who were not planning to quit smoking in the next 30 days. We recruited participants who were cigar-naïve, defined as smoking ≤50 cigars/cigarillos/little cigars in their lifetime and ≤10 in the past month. Inclusion criteria specified that participants must smoke a minimum of five cigarettes/day for the past three months and provide a semi-quantitative urine cotinine result of ≥3 at screening (NicAlert, Encino, CA, USA). Participants must have been in good health, defined by self-reported absence of chronic and psychiatric conditions and by heart rate and blood pressure readings measured at screening. We excluded participants who reported using cannabis or alcohol on more than 20 of the past 30 days or using any other illicit substances in the past month. Pregnant or breastfeeding women were excluded. Recruitment occurred in person, via print advertisements (flyers, handbills), on websites and online message boards, and through tobacco study registries between March 2017 and April 2019. Fifty-two participants consented to the full study, 34 were enrolled, and 25 completed all study activities. Among those who enrolled but did not complete the study, the most common reason for discontinuation or withdrawal was failure to attend sessions or contact the study team.
Procedures
Potentially eligible individuals attended an in-person screening during which they provided informed consent followed by assessment of urine cotinine and pregnancy status, demographics and tobacco use history, and baseline health. Included in the tobacco use history assessment were the Fagerström Test for Nicotine Dependence (FTND; Heatherton, Kozlowski, Frecker, & Fagerström, 1991) and items assessing cigar use history and frequency. Eligible participants were scheduled to attend five laboratory sessions, each a minimum of 48 hours apart. Abstinence from nicotine/tobacco for 12 hours was required before each session and was confirmed if an exhaled breath sample was ≤10 ppm carbon monoxide (Vitalograph, Lenexa, Kansas, USA). In each session, participants took two directed 10-puff bouts (separated by 60 minutes) of a different tobacco product: own brand (OB) cigarettes or one of four flavored cigars (“apple”, “cream”, “wine”, and “original”). All cigars were plastic-tipped Black & Mild brand (Altria Group, n.d.), one of the most popular brands in the US (Corey et al., 2018; Delnevo et al., 2015). Assessments of abuse liability for the session-specific product were completed at the end of each session (approximately 45 minutes since bout 2). Conditions were ordered by Latin square. Further detail is available in Wall et al. (2018). The study received ethics committee approval from the Virginia Commonwealth University Institutional Review Board and is registered at ClinicalTrials.gov (NCT02937051).
Measures
Abuse liability was measured using indices from three computerized behavioral economic choice tasks: the drug purchase task (DPT; i.e., an own-price purchase task), the cross-price purchase task, and the multiple choice procedure (MCP). For all three tasks, participants made a series of choices between 10 puffs of the session-specific tobacco product (i.e., OB cigarettes or a flavored cigar) and amounts of money ranging from $0 to $10.24 USD for the DPT and cross-price purchase task and from $0.01 to $10.24 for the MCP.
Drug purchase task
In the DPT, participants reported how many 10-puff bouts of the tobacco product they would purchase at a series of escalating prices (Carter et al., 2009; MacKillop, Goldenson, Kirkpatrick, & Leventhal, 2019; MacKillop et al., 2008). Participants were to assume they had no access to other tobacco products and all products would be consumed in one day. At each price, the total hypothetical expenditure was calculated (i.e., number of 10-puff bouts multiplied by price per 10 puffs) and displayed; participants were prompted to confirm their choice and could change their choices twice. The task ended after participants reported zero consumption at two consecutive prices. The DPT produces five indices of abuse liability: intensity, consumption when the product is hypothetically free; breakpoint, the first price at which consumption is suppressed to zero; Omax, maximum total tobacco expenditure for one day; Pmax, price at Omax; and elasticity, an index of price responsiveness (Few, Acker, Murphy, & MacKillop, 2012).
Cross-price purchase task
In the cross-price purchase task, participants made a series of choices about two concurrently available products (Stein, Koffarnus, Stepanov, Hatsukami, & Bickel, 2018). Participants reported how many 10-puff bouts of OB cigarettes and of the session-specific flavored cigar they would purchase when the cigar is available at a consistent price of $1 while OB cigarettes are available at a series of escalating prices. The outcome from this task is cross-price elasticity, which indicates how demand for an alternative product (here, flavored cigars) changes in response to changes in price for a separate product (here, OB cigarettes).
Multiple choice procedure
In the MCP (Barnes, Bono, Lester, Eissenberg, & Cobb, 2017; Griffiths, Troisi, Silverman, & Mumford, 1993), participants chose between receiving 10 puffs of the session-specific tobacco product or various amounts of money. To incentivize honest responding, one choice was randomly chosen to be reinforced after the task. Because reinforcement involved immediate receipt of either money or the tobacco product, the MCP was administered last in each session. The outcome of the MCP is the crossover point, or the price at which participants switch from choosing the tobacco product to choosing to receive money.
Data preparation and analysis
Data quality in the DPT was assessed using criteria adapted from Stein et al. (2015). For all DPT outcomes, one session was excluded due to reporting increasing consumption with increasing price and another was excluded due to missing data. Additionally, for elasticity analyses only, eight sessions were excluded because participants reported null demand across all prices. Individual demand curves were created per the following equation from Koffarnus and colleagues (2015):
In this equation, Q is the number of 10-puff bouts demanded at each price P, Q0 is the number of 10-puff bouts demanded at $0, the α parameter measures elasticity of demand (or rate of decline in consumption with increases in price), and k is a scaling factor set to 4. The equation provided good fit for the data, with R2 values ranging from 0.86 to >0.99. Demand curves provided estimates of elasticity; all other DPT outcomes were derived directly from the data.
For all DPT and MCP outcomes, mixed effects linear regressions with robust standard errors assessed differences between OB cigarettes and each cigar flavor. Follow-up Wald tests assessed significant pairwise differences between each cigar flavor. For the crossover point, intensity, breakpoint, Omax and Pmax, higher values indicate greater abuse liability. For elasticity, smaller values indicate greater abuse liability. Following these baseline analyses, we conducted sensitivity analyses for DPT and MCP outcomes. In separate models, we controlled for own brand cigarette menthol preference, previous use of cigars (i.e., ever use), and nicotine dependence. We examined whether menthol preference moderated the effects of cigar flavors on abuse liability using an interaction term. Finally, we examined the sensitivity of elasticity analyses to the exclusion of sessions with null demand across prices by imputing the eight missing elasticity values as the highest elasticity value observed in the sample plus 0.001 (Stein et al., 2018).
The cross-price purchase task was analyzed using a linear mixed effects model in which log-price of OB cigarettes was regressed on log-consumption of cigars. The cross-price elasticity of a flavored cigar was indicated by the regression coefficient (i.e., slope). A positive and significant slope indicated that the cigar functioned as a substitute for OB cigarettes, meaning that demand for the flavored cigar increased as OB cigarette prices increased. Follow-up Wald tests assessed differences in the cross-price elasticity values between each cigar flavor. We also described the percentage of participants who reported any consumption of cigars when OB cigarettes were free, and compared conditions using a chi-squared test. We examined these cases in further detail as they could either indicate propensity for dual use of cigars and cigarettes, or misunderstanding of or low-effort responding to the task.
Own-price demand curves were fit in GraphPad Prism 8 (San Diego, CA, USA); all other statistical analyses were conducted in Stata 15 (College Station, TX, USA). Statistical significance was assessed with p<0.05.
Results
Demographics
Of 25 participants, 64% were men and over half were non-Hispanic White (52%). The average age was 21.9 years (standard deviation [SD]=2.3). On average, participants smoked 9.2 (SD=3.8) cigarettes per day, and over half of participants reported that their OB cigarette contained menthol (52%). Mean nicotine dependence level assessed using the FTND was 2.84 (SD=1.81) of a possible 10, corresponding to a low level of dependence. The average number of lifetime cigars smoked was 9.5 (SD=12.3) and 88% of participants had ever used a cigar at baseline.
Behavioral economic choice tasks
Drug purchase task
Compared to OB cigarettes, all cigar flavors were associated with significantly lower intensity, breakpoint, and Omax values in the DPT (ps<0.05, see predicted means in Table 1). Wine flavor cigars had significantly lower Pmax values compared to OB cigarettes (p<0.05), while Pmax values for original, cream, and apple flavor cigars were not significantly different from OB cigarettes. No significant differences in elasticity values were observed between OB cigarettes and any cigar flavor, nor were pairwise differences observed between cigar flavors for any DPT outcome.
Table 1.
Abuse liability for own brand cigarettes and flavored Black & Mild cigars in the drug purchase task and multiple choice procedure among young adult smokers (N=25) (predicted mean (standard error)).
| Task | Multiple choice procedure | Drug purchase task | ||||
|---|---|---|---|---|---|---|
|
| ||||||
| Session product | Crossover point ($) | Intensity (number of products) | Breakpoint ($) | Omax ($) | Pmax ($) | Elasticity (α) |
| Own brand cigarettes | 0.86 (0.21) | 12.37 (2.01) | 4.57 (0.74) | 9.97 (2.46) | 2.67 (0.44) | 0.02 (0.01) |
| Original cigars | 1.00 (0.24) †‡ | 8.16 (1.05)* | 3.60 (0.70)* | 6.30 (1.64)* | 2.42 (0.39) | 0.07 (0.04) |
| Cream cigars | 0.86 (0.24) | 7.60 (1.14)* | 3.46 (0.69)* | 6.19 (1.49)* | 2.18 (0.35) | 0.06 (0.03) |
| Wine cigars | 0.61 (0.21)* † | 8.24 (1.54)* | 3.21 (0.71)* | 7.08 (2.10)* | 2.04 (0.38)* | 0.09 (0.06) |
| Apple cigars | 0.71 (0.20)* ‡ | 8.04 (1.30)* | 3.19 (0.66)* | 6.20 (1.75)* | 2.06 (0.40) | 0.13 (0.07) |
Asterisks (*) indicate significant differences between the cigar flavor and own brand cigarettes as assessed with mixed effects linear regressions, p<0.05. The paired symbols † and ‡ indicate significant pairwise differences between those two cigar flavors as assessed with follow-up Wald tests, p<0.05.
Cross-price purchase task
When cigars cost $1.00 but OB cigarettes were free, 12% of participants opted to purchase the condition-specific cigar in the wine condition compared to 16% in the cream condition and 20% each in the original and apple conditions; this distribution did not vary by cigar flavor (X2=0.78, p=0.85). All cigar flavors functioned as substitutes for OB cigarettes, as evidenced by positive and significant regression coefficients (ps<0.001, Table 2). No differences in cross-price elasticity between cigar flavors were observed.
Table 2.
Changes in log-cigar consumption associated with changes in log-price of own brand cigarettes from the cross-price purchase task among young adult smokers (N=25).
| Cigar flavor | Coefficient | p | 95% confidence interval |
|---|---|---|---|
|
| |||
| Original | 0.64 | <0.001 | (0.41, 0.86) |
| Cream | 0.58 | <0.001 | (0.34, 0.81) |
| Wine | 0.58 | <0.001 | (0.38, 0.79) |
| Apple | 0.57 | <0.001 | (0.34, 0.80) |
Note: Regression coefficients from the linear mixed effects model indicate the change in log-cigar consumption as log-prices for cigarettes increase. A significant, positive coefficient suggests that the cigar functions as a substitute for own brand cigarettes.
Multiple choice procedure
Across conditions, the mean price at which participants switched from choosing to receive the tobacco product to choosing to receive money was $0.81 (SD=1.10). On average, participants first preferred to receive money at a price point approximately $0.25 lower for wine flavor cigars and $0.15 lower for apple flavor cigars, relative to OB cigarettes (ps<0.05, Table 1). However, no significant differences were found between OB cigarettes and either cream or original flavor cigars. Among cigar flavors, crossover points for apple and wine cigars were significantly lower than crossover points for original (ps<0.05).
Sensitivity Analysis
Findings were not sensitive to controlling for menthol preference, previous cigar use, or nicotine dependence, although previous cigar use and nicotine dependence were independently associated with higher abuse liability in some analyses. Menthol preference moderated the effects of cigar flavors for two outcomes: relative to OB cigarettes, cream cigars were associated with lower crossover points among non-menthol smokers but higher crossover points among menthol smokers, and the effects of apple cigars on the crossover point and of wine and cream cigars on intensity of demand compared to OB cigarettes appeared strongest for non-menthol smokers. Finally, our findings regarding elasticity were sensitive to the exclusion of sessions with null demand. When imputing elasticity estimates for those with null demand, OB cigarettes were associated with significantly higher elasticity than cream, wine, and apple cigars. Sensitivity analysis results are provided in the Supplementary Material.
Discussion
This study examined abuse liability for Black & Mild cigar flavors among cigar-naïve young adult cigarette smokers using behavioral economic choice tasks. Using intensity, breakpoint, and Omax from the drug purchase task, abuse liability for flavored cigars was uniformly lower than abuse liability for OB cigarettes. However, for other outcomes, abuse liability did not differ between flavored cigars and OB cigarettes; moreover, all cigar flavors functioned as substitutes for OB cigarettes. Thus, while abuse liability was highest for participants’ usual tobacco product, these young adult smokers may be willing to use flavored cigars instead of or in addition to cigarettes.
Our results also suggest that among cigar flavors, original and cream may have the greatest appeal. Specifically, original scored higher than apple or wine using the MCP crossover point. Further, on multiple indices of abuse liability, both original and cream cigars were not significantly different from OB cigarettes, a product presumed to have high abuse liability among smokers. Our findings regarding the appeal of original-flavored cigars align with national sales data showing that in 2015, unflavored cigars (i.e., those without a flavor descriptor) made up nearly half of convenience store cigar sales (Delnevo et al., 2017). Additionally, among flavored brands, sweet/candy-flavored cigars (e.g., cream) generated greater sales than wine cigars—although unlike our findings on apple cigars, the cigar flavor category with the largest market share was fruit (Delnevo et al., 2017). Regulating flavors in cigar products could begin with policies that address those flavors associated with the highest abuse liability. However, cigar flavors such as “original” may evade regulations that focus solely on characterizing flavors other than tobacco or menthol (Viola, Giovenco, Miller Lo, & Delnevo, 2015). As cigars and cigarillos with and without characterizing flavors contain high-intensity sweeteners (Erythropel et al., 2018) that may contribute to taste and appeal, regulations that also account for specific product constituents such as sweeteners may be needed for a comprehensive public health response to flavor availability in cigars.
Limitations
In a small number of cases, participants would purchase cigars while OB cigarettes were free, which could represent either high valuation of cigars and propensity to dual use, or misunderstanding and inattentiveness to the task. However, as the distribution of these cases did not differ by experimental condition, we do not expect that their inclusion affects our findings. While our study design allowed us to control for many relevant characteristics, our findings may not generalize to other cigar flavors, populations, or regions, particularly as cigar preferences may differ between jurisdictions with and without legal cannabis markets (Giovenco, Spillane, Mauro, & Martins, 2018). Our sample included adults aged 18–25, although the federal minimum purchase age for tobacco products increased to 21 years since the time of our study. The definition of “cigar-naïve” in our exclusion criteria allowed up to 50 cigars over the lifetime and did not distinguish between tobacco-only cigars and cannabis-containing cigars (i.e., blunts), so our sample varied in baseline cigar familiarity (range: 0–50 lifetime cigar products). Though results were not sensitive to previous cigar use nor nicotine dependence levels, findings were at times sensitive to OB cigarette menthol preference and to excluding participants with null demand across prices in the drug purchase task. Further studies powered to detect differences by menthol smoking status may be warranted to untangle these relationships. Finally, though our hypothetical assessment of abuse liability provides evidence regarding flavors, this study is not designed to examine individual characteristics, other product features (e.g., packaging, price, marketing), use preferences and behaviors (e.g., co-use of cannabis) or social and policy environment factors that may influence flavored cigars’ abuse liability at the population level.
Conclusions
Among young adult smokers, abuse liability for Black & Mild cigars varies by cigar flavor. In some instances, abuse liability did not differ between flavored cigars and own brand cigarettes, and flavored cigars served as substitutes for cigarettes. Future analyses will triangulate findings from these behavioral assessments of abuse liability with evidence on the subjective and physiological effects and puff topography of flavored cigars (Wall et al., 2018). Cigar use is associated with multiple negative health outcomes and flavored cigars may be particularly attractive to young adults, making policies and regulations that address cigar flavors and flavoring additives essential to public health.
Supplementary Material
Public Health Significance.
In the United States, restrictions on characterizing flavors in tobacco products currently do not apply to cigars, despite evidence that flavors are attractive to youth and young adults. This study provides evidence that, for young adult smokers, some flavored cigars may have lower abuse liability than smokers’ own brand of cigarettes; however, flavored cigars may serve as substitutes for cigarettes. Further, some cigar flavors have higher abuse liability than others.
Disclosures and Acknowledgements
Funding was provided by the National Institute on Drug Abuse of the National Institutes of Health (award number R03DA043005). This research is supported by grant number U54DA036105 from the National Institute on Drug Abuse of the National Institutes of Health and the Center for Tobacco Products of the U.S. Food and Drug Administration. The content is solely the responsibility of the authors and does not necessarily represent the views of the NIH or the FDA. The funding source had no other role than financial support.
Footnotes
All authors have contributed to the manuscript in a significant way, and all have read and approved the manuscript.
TE is a paid consultant in litigation against the tobacco industry and also the electronic cigarette industry and is named on a patent for a device that measures the puffing behavior of electronic cigarette users. Although the following activities/relationships do not create a conflict of interest pertaining to this manuscript, in the interest of full disclosure, WKB would like to report the following: W. K. Bickel is a principal of HealthSim, LLC; BEAM Diagnostics, Inc.; and Red 5 Group, LLC. In addition, he serves on the scientific advisory board for Sober Grid, Inc. and is a consultant for Alkermes, Inc. and Sandoz, Inc. All other authors have no conflicts of interest to disclose.
Preliminary results for this project were presented at the 2019 Virginia Commonwealth University Massey Cancer Center Research Retreat (June 8, 2019, Richmond VA), the 2018 and 2019 National Institutes of Health Tobacco Regulatory Science Meeting (June 18–20, 2018 and October 21–23, 2019; Bethesda MD), and the 2020 Society for Research on Nicotine and Tobacco Annual Meeting (March 11–14, 2020; New Orleans LA). The study was preregistered at ClinicalTrials.gov (number NCT02937051).
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