Centering racial justice for Black/African American and Indigenous American people in commercial tobacco product regulation.

Although overall health in the United States (US) has improved dramatically during the past century, long-standing health inequities, particularly the unequal and unjust burden of tobacco-related disease and death among racialized populations, persist. A considerable gap exists in our understanding of how commercial tobacco product regulations and policies cause and/or exacerbate race-based health inequities among Black/African American (B/AA) and Indigenous American people. The purpose of this paper is to 1) describe how existing US commercial tobacco regulatory policies may contribute to structural racism and undermine the full benefits of tobacco prevention and control efforts among B/AA and Indigenous American groups; and 2) initiate a call to action for researchers and regulators of tobacco products to examine policies using an equity lens. These actions are imperative if empirically-informed regulation of commercial tobacco products is to address health equity.

The Influence of a Mouthpiece-Based Topography Measurement Device on Electronic Cigarette User's Plasma Nicotine Concentration, Heart Rate, and Subjective Effects Under Directed and Ad Libitum Use Conditions.

INTRODUCTION: Electronic cigarettes e-cigarettes aerosolize a liquid solution often containing nicotine. e-cigarette nicotine delivery may be influenced by user puffing behaviors ("puff topography"). E-cigarette puff topography can be recorded using mouthpiece-based computerized systems. The present study sought to examine the extent to which these systems influence e-cigarette nicotine delivery and other e-cigarette associated acute effects under ad libitum use conditions. METHODS: Plasma nicotine concentration, heart rate, and subjective effects were assessed in 29 experienced e-cigarette users using their preferred e-cigarette battery and liquid (≥12mg/mL nicotine) in two sessions differing only by the presence of a mouthpiece-based device. In both sessions, participants completed a directed e-cigarette use bout (10 puffs, 30-s interpuff interval) and a 90-min ad libitum bout. Puff topography was recorded in the session with the topography mouthpiece. RESULTS: Plasma nicotine, heart rate, and subjective effects, aside from "Did the e-cigarette Taste Good?" were independent of topography measurement (higher mean taste ratings were observed in the no topography condition). Mean (SEM) plasma nicotine concentration following the ad libitum bout was 34.3ng/mL (4.9) in the no topography condition and 35.7ng/mL (4.3) in the topography condition. Longer puff durations, longer interpuff intervals, and larger puff volumes were observed in the ad libitum relative to the directed bout. CONCLUSIONS: E-cigarette use significantly increased plasma nicotine concentration and heart rate while suppressing abstinence symptoms. These effects did not differ when a topography mouthpiece was present. Future studies using ad libitum e-cigarette use bouts would facilitate understanding of e-cigarette toxicant yield. IMPLICATIONS: No prior study has examined whether mouthpiece-based topography recording devices influence e-cigarette associated nicotine delivery, heart rate, or subjective effects under ad libitum conditions or assessed ad libitum puff topography in experienced individuals using their preferred e-cigarette battery and liquid with a mouthpiece-based computerized device. E-cigarette use significantly increased plasma nicotine concentration and heart rate while suppressing abstinence symptoms. These effects did not differ when a topography mouthpiece was present. Ad libitum puff topography differed from puff topography recorded during directed puffing. These findings suggest that future studies using ad libitum use bouts would facilitate better understanding of e-cigarette toxicant yield.

Effects of Electronic Cigarette Liquid Nicotine Concentration on Plasma Nicotine and Puff Topography in Tobacco Cigarette Smokers: A Preliminary Report.

INTRODUCTION: Electronic cigarettes (ECIGs) aerosolize a liquid that usually contains propylene glycol and/or vegetable glycerin, flavorants, and the dependence-producing drug nicotine in various concentrations. This study examined the extent to which ECIG liquid nicotine concentration is related to user plasma nicotine concentration in ECIG-naïve tobacco cigarette smokers. METHODS: Sixteen ECIG-naïve cigarette smokers completed four laboratory sessions that differed by the nicotine concentration of the liquid (0, 8, 18, or 36 mg/ml) that was placed into a 1.5 Ohm, dual coil "cartomizer" powered by a 3.3V battery. In each session, participants completed two, 10-puff ECIG use bouts with a 30-second inter-puff interval; bouts were separated by 60 minutes. Venous blood was sampled before and after bouts for later analysis of plasma nicotine concentration; puff duration, volume, and average flow rate were measured during each bout. RESULTS: In bout 1, relative to the 0mg/ml nicotine condition (mean = 3.8 ng/ml, SD = 3.3), plasma nicotine concentration increased significantly immediately after the bout for the 8 (mean = 8.8 ng/ml, SD = 6.3), 18 (mean = 13.2 ng/ml, SD = 13.2), and 36 mg/ml (mean = 17.0 ng/ml, SD = 17.9) liquid concentration. A similar pattern was observed after bout 2. Average puff duration in the 36 mg/ml condition was significantly shorter compared to the 0mg/ml nicotine condition. Puff volume increased during the second bout for 8 and 18 mg/ml conditions. CONCLUSIONS: For a given ECIG device, nicotine delivery may be directly related to liquid concentration. ECIG-naïve cigarette smokers can, from their first use bout, attain cigarette-like nicotine delivery profiles with some currently available ECIG products. IMPLICATIONS: Liquid nicotine concentration can influence plasma nicotine concentration in ECIG-naïve cigarette smokers, and, at some concentrations, the nicotine delivery profile of a 3.3V ECIG with a dual coil, 1.5-Ohm cartomizer approaches that of a combustible tobacco cigarette in this population. Finding a product that delivers nicotine as effectively as a tobacco cigarette, as we report here, may be essential for smokers who want to replace completely their combustible tobacco cigarettes with ECIGs.

Electronic cigarette nicotine delivery can exceed that of combustible cigarettes: a preliminary report.

INTRODUCTION: Electronic cigarettes (ECIGs) aerosolise a liquid that usually contains propylene glycol and/or vegetable glycerine, flavourants and the dependence-producing drug, nicotine, in various concentrations. This laboratory study examined the relationship between liquid nicotine concentration and plasma nicotine concentration and puffing behaviour in experienced ECIG users. METHODS: Sixteen ECIG-experienced participants used a 3.3-Volt ECIG battery attached to a 1.5-Ohm dual-coil 'cartomiser' loaded with 1 mL of a flavoured propylene glycol/vegetable glycerine liquid to complete four sessions, at least 2 days apart, that differed by nicotine concentration (0, 8, 18 or 36 mg/mL). In each session, participants completed two 10-puff ECIG-use bouts (30 s puff interval) separated by 60 min. Venous blood was sampled to determine plasma nicotine concentration. Puff duration, volume and average flow rate were measured. RESULTS: Immediately after bout 1, mean plasma nicotine concentration was 5.5 ng/mL (SD=7.7) for 0 mg/mL liquid, with significantly (p<0.05) higher mean concentrations observed for the 8 (mean=17.8 ng/mL, SD=14.6), 18 (mean=25.9 ng/mL, SD=17.5) and 36 mg/mL (mean=30.2 ng/mL; SD=20.0) concentrations; a similar pattern was observed for bout 2. For bout 1, at 36 mg/mL, the mean post- minus pre-bout difference was 24.1 ng/mL (SD=18.3). Puff topography data were consistent with previous results and revealed few reliable differences across conditions. DISCUSSION: This study demonstrates a relationship between ECIG liquid nicotine concentration and user plasma nicotine concentration in experienced ECIG users. Nicotine delivery from some ECIGs may exceed that of a combustible cigarette. The rationale for this higher level of nicotine delivery is uncertain.

Preliminary results of an examination of electronic cigarette user puff topography: the effect of a mouthpiece-based topography measurement device on plasma nicotine and subjective effects.

INTRODUCTION: Electronic cigarettes (ECIGs) heat a nicotine-containing solution; the resulting aerosol is inhaled by the user. Nicotine delivery may be affected by users' puffing behavior (puff topography), and little is known about the puff topography of ECIG users. Puff topography can be measured using mouthpiece-based computerized systems. However, the extent to which a mouthpiece influences nicotine delivery and subjective effects in ECIG users is unknown. METHODS: Plasma nicotine concentration, heart rate, and subjective effects were measured in 13 experienced ECIG users who used their preferred ECIG and liquid (≥ 12 mg/ml nicotine) during 2 sessions (with or without a mouthpiece). In both sessions, participants completed an ECIG use session in which they were instructed to take 10 puffs with 30-second inter-puff intervals. Puff topography was recorded in the mouthpiece condition. RESULTS: Almost all measures of the effects of ECIG use were independent of topography measurement. Collapsed across session, mean plasma nicotine concentration increased by 16.8 ng/ml, and mean heart rate increased by 8.5 bpm (ps < .05). Withdrawal symptoms decreased significantly after ECIG use. Participants reported that the mouthpiece affected awareness and made ECIG use more difficult. Relative to previously reported data for tobacco cigarette smokers using similar topography measurement equipment, ECIG-using participants took larger and longer puffs with lower flow rates. CONCLUSIONS: In experienced ECIG users, measuring ECIG topography did not influence ECIG-associated nicotine delivery or most measures of withdrawal suppression. Topography measurement systems will need to account for the low flow rates observed for ECIG users.

Interactive effects of protonated nicotine concentration and device power on ENDS nicotine delivery, puff topography, and subjective effects.

Electronic nicotine delivery systems (ENDSs) produce an aerosol by heating a liquid that often contains nicotine. The nicotine can be protonated that may make the aerosol easier to inhale than freebase nicotine. This study's purpose is to determine, in cigarette smokers and ENDS users, the effects of three concentrations of protonated nicotine aerosolized at two different power settings. Forty-five participants (22 cigarette smokers and 23 ENDS users) completed some or all of six sessions that varied by liquid nicotine concentration (10, 15, or 30 mg/ml protonated nicotine) and device power (15 or 30 W). Participants took 10 puffs from each product and then used each product for 90 min ad libitum. Plasma nicotine concentration, subjective effects, and puff topography were measured. Results showed increases in plasma nicotine concentration in all conditions, with greater plasma nicotine increases in higher watt, higher nicotine concentration conditions, as well as greater nicotine delivery for ENDS users compared to cigarette smokers. For puff topography, puff duration and volume decreased as nicotine concentration and power increased, and ENDS users took longer and larger puffs than cigarette smokers. Participants rated the higher watt, higher nicotine concentration conditions as harsher and with more throat hit. Overall, these results suggest that device characteristics and liquid constituents interact to influence users' plasma nicotine delivery and should be considered together when regulating ENDS. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Electronic Nicotine Delivery System flavor use over time by age group in the US: A longitudinal analysis.

INTRODUCTION: The prevalence of flavor use in Electronic Nicotine Delivery Systems (ENDS) has been assessed in numerous studies, but limited research has focused on flavor use trends and maintenance of flavor preference over time. This study investigated the general trends and maintenance of ENDS flavor use for youth (aged 12-17 years), young adults (aged 18-24 years), and older adults (aged ≥25 years) between 2014 and 2019. METHODS: Population Assessment of Tobacco and Health (PATH) Study Wave 2 (2014-2015), Wave 3 (2015-2016), Wave 4 (2016-2017), and Wave 5 (2018-2019) youth and adult data were used. Cross-sectional flavor use prevalence (trends) and flavor maintenance (using the same flavor category in at least three consecutive waves) were assessed. RESULTS: The most reported primary flavor category was fruit among all age groups in all waves. Candy/desserts in waves two, three, four, and menthol/mint in wave five were the second most reported flavor in all age groups. The highest increase was observed for menthol/mint use among youth between wave two (21.9%) and five (58.1%) (OR=5.33; 95% CI: 3.58-7.96). Overall, 37.6% of fruit flavor users, 25.3% of candy/desserts users, 32.0% of menthol/mint users, and 33.4% of tobacco flavor users, maintained use of the same flavor in at least three consecutive waves. CONCLUSIONS: Fruit flavor had the highest percentages of use and maintenance between 2014 and 2019. While the maintenance of fruit and candy/desserts flavors were higher among youth, adults had substantially higher maintenance percentages for menthol/mint and tobacco flavor. There was a substantial increase in menthol/mint use in wave five among youth, which may affect ENDS flavor maintenance patterns in the future. Understanding maintenance of flavors over time can inform regulation of ENDS flavors.

The Vaping and Patterns of e-Cigarette Use Research Study: Protocol for a Web-Based Cohort Study.

BACKGROUND: In total, 3.2% of American adults report using e-cigarettes every day or some days. The Vaping and Patterns of E-cigarette Use Research (VAPER) Study is a web-based longitudinal survey designed to observe patterns in device and liquid use that suggest the benefits and unintended consequences of potential e-cigarette regulations. The heterogeneity of the e-cigarette devices and liquids on the market, the customizability of the devices and liquids, and the lack of standardized reporting requirements result in unique measurement challenges. Furthermore, bots and survey takers who submit falsified responses are threats to data integrity that require mitigation strategies. OBJECTIVE: This paper aims to describe the protocols for 3 waves of the VAPER Study and discuss recruitment and data processing experiences and lessons learned, including the benefits and limitations of bot- and fraudulent survey taker-related strategies. METHODS: American adults (aged ≥21 years) who use e-cigarettes ≥5 days per week are recruited from up to 404 Craigslist catchment areas covering all 50 states. The questionnaire measures and skip logic are designed to accommodate marketplace heterogeneity and user customization (eg, different skip logic pathways for different device types and customizations). To reduce reliance on self-report data, we also require participants to submit a photo of their device. All data are collected using REDCap (Research Electronic Data Capture; Vanderbilt University). Incentives are US $10 Amazon gift codes delivered by mail to new participants and electronically to returning participants. Those lost to follow-up are replaced. Several strategies are applied to maximize the odds that participants who receive incentives are not bots and are likely to possess an e-cigarette (eg, required identity check and photo of a device). RESULTS: In total, 3 waves of data were collected between 2020 and 2021 (wave 1: n=1209; wave 2: n=1218; wave 3: n=1254). Retention from waves 1 to 2 was 51.94% (628/1209), and 37.55% (454/1209) of the wave 1 sample completed all 3 waves. These data were mostly generalizable to daily e-cigarette users in the United States, and poststratification weights were generated for future analyses. Our data offer a detailed examination of users' device features and specifications, liquid characteristics, and key behaviors, which can provide more insights into the benefits and unintended consequences of potential regulations. CONCLUSIONS: Relative to existing e-cigarette cohort studies, this study methodology has some advantages, including efficient recruitment of a lower-prevalence population and collection of detailed data relevant to tobacco regulatory science (eg, device wattage). The web-based nature of the study requires several bot- and fraudulent survey taker-related risk-mitigation strategies, which can be time-intensive. When these risks are addressed, web-based cohort studies can be successful. We will continue to explore methods for maximizing recruitment efficiency, data quality, and participant retention in subsequent waves. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38732.

Reactions to a Hypothetical Menthol Cigarette Ban among Sexual- and Gender-Minoritized Communities: A Concept Mapping Study.

Menthol cigarette use is disproportionately higher among sexual- and gender-minoritized (SGM; 36%) individuals compared to cisgender, heterosexual (29%), individuals. The FDA has announced intentions to ban menthol in cigarettes, citing these use and health disparities as partial motivation. This study identified potential outcomes of a menthol cigarette ban among SGM individuals who smoke menthol cigarettes (N = 72). Potential outcomes were identified via concept mapping using the prompt: "If menthol in cigarettes was banned, a specific action I would take related to my tobacco use is…" Participants generated 82 response statements, sorted them, and rated them on personal relevance. Eight thematic clusters were identified: (1) Thoughtful Consideration of the Ban, (2) Negative Reactions to the Ban, (3) Positive Aspects of the Ban, (4) Strategies to Reduce Cravings, (5) Intent to Quit and Cessation Strategies, (6) Support-Seeking and Engagement in Positive Behaviors, (7) Strategies to Maintain Menthol-Flavored Product Use, and (8) Substance Use Alternatives to Menthol Cigarettes. Cluster differences based on sociodemographic factors, smoking behavior, and quitting interest were identified. Results provide insight into potential responses to a menthol cigarette ban and can contribute to public health prevention and intervention efforts, messaging campaigns, and support services for SGM people who smoke menthol cigarettes, specifically.

Survey of U.S. Residents and Their Usage of Electronic Cigarettes with Drugs Other Than Nicotine.

Electronic cigarettes (e-cigs), originally intended to be used as cigarette substitutes, have evolved into discreet devices for consuming drugs other than nicotine (DOTNs). Presented are the results of an exploratory survey in which information regarding demographics, e-cig device type, DOTN use, frequency and context of use was collected. The average reported age of respondents was 27.4 years of age (SD = 12.0), and respondents predominantly identified as male (73%). Vape pens (disposable or refillable) were the most reported device across all DOTN classes. Cannabinoids were the most reported class of DOTN used, for both lifetime and past 30-day use. Other DOTNs reported included herbal supplements, amphetamines, caffeine, kratom, vitamins, opiates, DMT, fentanyl, and ketamine. Combinations of DOTNs used in e-cigs and trends in poly-substance use were reported. The most commonly reported context was vaping alone, followed by with friends, at home, and at social events; less commonly reported contexts included when driving, at work, and at school. Results from this study are useful for developing future national surveys to consider a comprehensive substance use-focused strategy that includes vaping, building awareness of DOTN e-cig use, and highlighting public safety issues in driving impairment, crime scene investigations, and death investigations.

The impact of vaping ethanol-containing electronic cigarette liquids on roadside impairment investigations.

Legal professionals and others have suggested that vaping electronic cigarettes (e-cigs) prior to or during ethanol breath testing may produce false positives. Preliminary breath tests (PBTs) and evidentiary breath tests (EBTs) measure ethanol in exhaled breath and standardized field sobriety tests (SFSTs) are used to assess impairment. Ethanol has been identified in e-cig liquids (e-liquids). Presented are a series of experiments designed to determine the mechanics of vaping ethanol using an e-cig and the effects of vaping ethanol on the SFSTs and breath tests used by law enforcement officers (LEO). Twelve participants (five females, age: 21-32 and seven males, age: 21-55), vaped either one or ten puffs of an e-liquid (0% or 20% ethanol). LEOs assessed impairment using SFSTs (12 and 42 min), PBTs (<1, 27, 32, 37 and 57 min) and EBTs (2, 29, 34, 39 and 59 min) post-vaping. A self-assessment test was administered post-vaping (22 and 52 min). Baseline responses for all measures were collected prior to vaping. Results demonstrated that ethanol in the e-liquids was aerosolized by e-cigs and produced particles that could reach the deep lung tissue based on mean-mass diameter. Ethanol was detected by PBT <3 min after participants vaped one (0.007-0.030 g/210 L) or ten puffs (013-0.074 g/210 L) of a 20% ethanol e-liquid. Ethanol was not detected by PBT at any subsequent time point. Ethanol was not detected by the EBT under any condition. Impairment was not indicated by the SFST. Some subjective effects were reported, but few statistically significant differences between conditions were indicated. A wait period prior to ethanol breath testing is not always mandated, depending on jurisdiction, or observed in all applications, such as workplace testing. The results demonstrate that a wait period must be employed to prevent vaping-related false-positive breath ethanol results.

Nicotine/tobacco use disparities among transgender and gender diverse adults: Findings from wave 4 PATH data.

BACKGROUND: Transgender and Gender Diverse (TGD) populations have current cigarette/e-cigarette/cigar use rates ranging from 32.6% to 39.7%. Importantly, while some studies have reported tobacco use as significantly higher among TGD versus cisgender individuals in multivariate analyses, others have reported no significant differences. The present study used data from wave 4 of the Population Assessment of Tobacco and Health (PATH) study, a large, nationally representative U.S. study, to examine relationships among sociodemographic characteristics, internal and external factors, and tobacco use behaviors, with a focus on TGD individuals. METHODS: Data were from 33,628 adults from the PATH study's wave 4 (collected December 2016-January 2018). Multivariable logistic regression models examined differences in current tobacco use (cigarettes, electronic nicotine products, and cigars) between TGD and cisgender individuals through the replication of previous work using PATH data, as well as evaluating the role of other internal and external factors. RESULTS: TGD individuals were 2-3 times more likely than cisgender individuals to report current nicotine/tobacco use, even after adjustment for potential confounders. TGD individuals tended to have lower income and education and be more likely to endorse a sexual minority identity than their cisgender counterparts; meanwhile, lower income, less education, and lesbian/gay and bisexual identities were significant predictors of nicotine/tobacco use, independent of TGD identity. CONCLUSIONS: Present findings underscore the high rates of nicotine/tobacco use in the TGNC community and emphasize the necessity of TGD-focused research methods and measures, access to quality medical care, and policy aimed at minimizing marginalization and nicotine/tobacco use disparities experienced by TGD communities.

Combinations of electronic nicotine delivery system device and liquid characteristics among U.S. adults.

INTRODUCTION: The combination of electronic nicotine delivery systems (ENDS) device and liquid characteristics affect user nicotine and toxicant exposure, however population-level national survey studies have not reported device and liquid features jointly nor in detail. We examined combinations of characteristics of devices and liquids used by adult ENDS users. METHODS: U.S. adults (21+) using ENDS at least five days/week (n = 1,179) completed an online survey in 2020 and uploaded photos of their most used device and liquid. Device/liquid combinations were analyzed to determine and describe the most common pairings. Data were weighted to the U.S. population of adult daily ENDS users. RESULTS: Five device/liquid combinations accounted for 87 % of those reported. The most prevalent combination, reported by 36.2 %, was re-useable devices with adjustable settings and a tank refilled with a free-base nicotine liquid with a median nicotine concentration of 5.2 mg/mL. The second most frequent combination - re-usable devices with no adjustable settings and a nicotine salt liquid in a disposable pod or cartridge - was reported by 22.8 % and the median nicotine concentration was 49.4 mg/mL. Wattage, voltage and resistance varied across device/liquid combination. Overall, 66.5 % refilled their device's tank or pod and 64.2 % had the ability to manipulate device characteristics (power, airflow, and/or coil). CONCLUSIONS: Analyzing ENDS device/liquid combinations rather than each separately can allow researchers to better evaluate relationships between use and key outcomes, such as quitting cigarettes and abuse liability. Additional research may reveal whether certain combinations are more effective at helping smokers quit and which device/liquid combinations should remain on the market.

Impacts of COVID-19 on cigarette use, smoking behaviors, and tobacco purchasing behaviors.

BACKGROUND: The COVID-19 pandemic has had a significant global impact. As a respiratory illness, COVID-19 may pose unique risks to cigarette smokers. This study used concept mapping, a mixed-method participatory approach, to identify impacts of COVID-19 on cigarette smokers. METHODS: Cigarette smokers across the United States (U.S.) were recruited to complete this online, multi-step study. Of the 126 participants who were invited to participate in this study, 91 participants (mean age = 40.9; SD = 11.3) completed at least one of the three study tasks (i.e., brainstorming, sorting, and rating). Participants completed a brief demographic survey and brainstormed statements that completed a focus prompt: "A specific way that Coronavirus/COVID-19 has impacted/affected my cigarette use, smoking behaviors, tobacco purchasing behaviors, and/or other tobacco-related behaviors is." After duplicate statements were removed, participants sorted the final list of 87 statements by similarity of content and rated how true statements were from them (1-Definitely NOT true to 7-Definitely true). RESULTS: Nine thematic clusters were identified: Smoking More, Smoking to Cope/Reduce Stress, Change in Smoking Behaviors Due to COVID-19, Concerns about Smoking and COVID-19 Risk, Social Impacts, Maintaining and Rationing Cigarette Supply, Impacts on Obtaining Cigarettes, Use of Other Tobacco Products/Drugs, and Minimal/No Impacts/Concerns of COVID-19. The highest rated cluster (i.e., most true) was the Smoking More cluster followed by the Concerns about Smoking and COVID-19 Risk cluster. The highest rated statement in the study was the statement "Smoking keeps me calm". CONCLUSIONS: Cigarette smokers may endure additional impacts of COVID-19, such as increased COVID-19 health burdens, stressors related to risk of exposure, social stigma and isolation, financial burdens, and increased toxicant exposure from increased smoking frequency.

An Ultra-High-Pressure Liquid Chromatographic Tandem Mass Spectrometry Method for the Analysis of Benzoyl Ester Derivatized Glycols and Glycerol.

Presented is an ultra-high-pressure liquid chromatographic tandem mass spectrometry (UPLC-MS/MS) method developed for the detection of propylene glycol, glycerol, ethylene glycol and diethylene glycol using isotopically labeled standards in urine as part of ongoing studies to evaluate whether urinary propylene glycol and/or vegetable glycerin concentration are indicators of recent use. Propylene glycol and vegetable glycerol are found in many products that are consumed and used including electronic cigarettes (e-cigarettes). E-cigarettes are battery-powered devices used as an alternative to traditional cigarettes. The liquid formulations aerosolized in these devices largely consist of propylene glycol and/or vegetable glycerol. Published reports regarding the ratio of propylene glycol to glycerol content in these formulations ranged from 50:50 to 100 percent of either. For the analysis of urine specimens from both users and non-users of e-cigarettes, calibrators, controls and specimens were derivatized using benzoyl chloride prior to analysis. They were analyzed using a Waters AcQuity Xevo TQ-S Micro UPLC-MS/MS. Chromatographic separation was performed on an AcQuity UPLC BEH C18 1.7 um, 2.1 × 50 mm, column using a 20 mM ammonium formate in water and 20 mM ammonium formate in methanol as the mobile phase. The method was validated using SWGTOX guidelines for linearity, precision and accuracy, stability, carryover and limit of detection. The linear range was determined using a seven-point calibration curve ranging between 0.5 and 100 mcg/mL. The bias for all validation controls was determined to be ±20% of the expected concentrations with CVs of <15%. A total of 124 urine specimens analyzed collected with 50 specimens collected from self-reported non-smokers (cigarettes/e-cigarettes) confirmed cotinine free using the DRI® Cotinine Assay (Thermo Scientific, Waltham, MA) and 74 specimens collected before and after 12 hours self-reported e-cigarettes abstinence e-cigarette users. Propylene glycol and glycerol were determined to have concentration ranges of "none detected" to 1470 and "none detected" to 2950 mcg/mL, respectively.

Measuring perceptions related to e-cigarettes: Important principles and next steps to enhance study validity.

Measuring perceptions associated with e-cigarette use can provide valuable information to help explain why youth and adults initiate and continue to use e-cigarettes. However, given the complexity of e-cigarette devices and their continuing evolution, measures of perceptions of this product have varied greatly. Our goal, as members of the working group on e-cigarette measurement within the Tobacco Centers of Regulatory Science (TCORS) network, is to provide guidance to researchers developing surveys concerning e-cigarette perceptions. We surveyed the 14 TCORS sites and received and reviewed 371 e-cigarette perception items from seven sites. We categorized the items based on types of perceptions asked, and identified measurement approaches that could enhance data validity and approaches that researchers may consider avoiding. The committee provides suggestions in four areas: (1) perceptions of benefits, (2) harm perceptions, (3) addiction perceptions, and (4) perceptions of social norms. Across these 4 areas, the most appropriate way to assess e-cigarette perceptions depends largely on study aims. The type and number of items used to examine e-cigarette perceptions will also vary depending on respondents' e-cigarette experience (i.e., user vs. non-user), level of experience (e.g., experimental vs. established), type of e-cigarette device (e.g., cig-a-like, mod), and age. Continuous formative work is critical to adequately capture perceptions in response to the rapidly changing e-cigarette landscape. Most important, it is imperative to consider the unique perceptual aspects of e-cigarettes, building on the conventional cigarette literature as appropriate, but not relying on existing conventional cigarette perception items without adjustment.

Effects of electronic cigarette liquid solvents propylene glycol and vegetable glycerin on user nicotine delivery, heart rate, subjective effects, and puff topography.

BACKGROUND: Electronic cigarettes (ECIGs) are a class of tobacco products that produce different effects (e.g., nicotine delivery), depending on the device, liquid, and behavioral factors. However, the influence of the two primary ECIG liquid solvents, propylene glycol (PG) and vegetable glycerin (VG), on ECIG acute effects is unknown. METHODS: Thirty ECIG-experienced, ≥12-h nicotine- abstinent participants completed four conditions consisting of two ECIG-use bouts (10 puffs, 30 s interpuff-interval) differing only by liquid PG:VG ratio (2PG:98VG, 20PG:80VG, 55PG:45VG, 100PG). Device power (7.3 W) and liquid nicotine concentration (18 mg/ml) remained constant. Nicotine delivery, subjective effects, heart rate (HR), and puff topography were assessed. RESULTS: In the 100PG condition, participants took shorter and smaller puffs but obtained significantly more nicotine relative to the two VG-based conditions. Total nicotine exposure (i.e., area under the curve) was also significantly higher during use of the two PG-based liquids. However, participants reported that the 100 PG liquid was significantly less "pleasant" and "satisfying" relative to the other liquids (all ps < .05). Increases in HR and decreases in abstinence symptoms (e.g., "craving") did not differ across conditions. CONCLUSIONS: PG:VG ratio influenced nicotine delivery, some subjective effects, and puff topography. Lower overall product satisfaction associated with the 100PG liquid suggests factors other than nicotine delivery (e.g., aerosol visibility) may play a role in maintaining ECIG use. Regulating ECIG acute effects such as nicotine delivery and subjective effects may require simultaneous attention to liquid PG:VG ratio as well as device, liquid, and behavioral factors known to influence these outcomes.

Expanding clinical laboratory tobacco product evaluation methods to loose-leaf tobacco vaporizers.

BACKGROUND: Novel tobacco products entering the US market include electronic cigarettes (ECIGs) and products advertised to "heat, not burn" tobacco. There is a growing literature regarding the acute effects of ECIGs. Less is known about "heat, not burn" products. This study's purpose was to expand existing clinical laboratory methods to examine, in cigarette smokers, the acute effects of a "heat, not burn" "loose-leaf tobacco vaporizer" (LLTV). METHODS: Plasma nicotine and breath carbon monoxide (CO) concentration and tobacco abstinence symptom severity were measured before and after two 10-puff (30-s interpuff interval) product use bouts separated by 60min. LLTV effects were compared to participants' own brand (OB) cigarettes and an ECIG (3.3V; 1.5ohm; 18mg/ml nicotine). RESULTS: Relative to OB, LLTV increased plasma nicotine concentration to a lesser degree, did not increase CO, and did not appear to reduce abstinence symptoms as effectively. Relative to ECIG, LLTV nicotine and CO delivery and abstinence symptom suppression did not differ. Participants reported that both the LLTV and ECIG were significantly less satisfying than OB. CONCLUSIONS: Results demonstrate that LLTVs are capable of delivering nicotine and suppressing tobacco abstinence symptoms partially; acute effects of these products can be evaluated using existing clinical laboratory methods. Results can inform tobacco product regulation and may be predictive of the extent that these products have the potential to benefit or harm overall public health.

Measurement of smoking behavior: Comparison of self-reports, returned cigarette butts, and toxicant levels.

A basic tenet of empirical research on cigarette smoking behavior is the systematic assessment of patterns of use. However, the large majority of extant research relies on smokers' retrospective reports of their average number of cigarettes per day (CPD), a measure that may be variable in terms of reliability and validity. Using data from 3 previously published studies of non-treatment-seeking daily smokers (combined N = 89), this analysis examined the reliability of self-reported CPD, the consistency of returned cigarette butts each day over 4 consecutive 24-hr periods, the validity of self-reported CPD compared with returned cigarette butts, and the relationship of CPD and returned cigarette butts to toxicant exposure. Results showed that self-reported CPD was reliable across telephone and in-person screening interviews (r = .87, p < .01). Although average self-reported CPD and returned cigarette butt counts did not differ significantly, t(87) = -1.5 to 0.3, all ns, butt counts revealed a wider range of variability in daily smoking behavior. In addition, self-reported cigarette use exhibited substantial digit bias (Whipple's index = 413.8), meaning that participants tended to round their estimates to values ending in 0 or 5. Cigarette butt counts, but not self-reported CPD, were significantly associated with exposure to smoke toxicants. However, this former relationship was revealed to be linear, but not curvilinear, in nature. These findings have implications for both research and treatment efforts, as researchers often rely on accurate assessment of CPD to predict a variety of smoking-related outcomes. (PsycINFO Database Record