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Introduction Electronic cigarettes (ECIGs) heat a nicotine-containing liquid to produce an inhalable aerosol. ECIG power (wattage) and liquid nicotine concentration are two factors that predict nicotine emission rate ("flux"). These factors can vary greatly across devices and users. Aims and Methods The purpose of this study was to examine ECIG device and liquid heterogeneity in "real world" settings and the association with predicted nicotine flux, nicotine yield, and total particulate matter (TPM) emissions. Past 30-day ECIG users (n = 84; mean age = 23.8 years [SD = 9.6]) reported device and liquid characteristics. Device power was measured via multimeter, device display screens, or obtained via labeling. Liquid nicotine concentration was obtained via labeling or through chemical analysis. Predicted nicotine flux, nicotine yield, and TPM associated with 10 4-second puffs were calculated for participants' primary devices. Results Participants' primary devices were box mods (42.9%), disposable vapes (20.2%), and pod mods (36.9%). Most participants (65.5%) reported not knowing their primary device wattage. Rebuildable/box mods had the greatest power range (11.1–120.0 W); pod mod power also varied considerably (4.1–21.7 W). Unlike device wattage, most participants (95.2%) reported knowing their liquid nicotine concentration, which ranged from 3.0 to 86.9 mg/ml (M = 36.0, SD = 29.3). Predicted nicotine flux varied greatly across products (range =12.0–160.1 μg/s, M = 85.6 μg/s, SD = 34.3). Box mods had the greatest variability in wattage and predicted nicotine flux, nicotine yield, and TPM yield. Conclusions ECIG device and liquid heterogeneity influence nicotine and other toxicant emissions. Better measurement of ECIG device and liquid characteristics is needed to understand nicotine and toxicant emissions and to inform regulatory policy. Implications ECIG device and liquid heterogeneity cause great variability in nicotine flux and toxicants emitted. These data demonstrate the need to examine device and liquid characteristics to develop empirically informed, health-promoting regulatory policies. Policies may include setting product standards such that ECIG products cannot (1) have nicotine fluxes much greater than that of a cigarette to decrease the risk of dependence, (2) have nicotine fluxes that are very low and thus would have minimal appeal to cigarette smokers and may serve as starter products for youth or nontobacco users, and (3) emit large amounts of particulate matter and other toxicants. [ABSTRACT FROM AUTHOR]

Introduction: E-cigarette liquid nicotine concentrations typically are labeled as mg/mL or percent, which poorly convey nicotine strength to users. We evaluated whether four novel nicotine concentration labels better convey information about nicotine strength and addictiveness.Methods: Adolescents and young adults (N = 826) completed an online survey in 2020. Participants rated nicotine concentrations (3, 6, 18, 30, 40, and 50 mg/mL) from "no nicotine" to "very high nicotine" communicated using current market labels (mg/mL, percent) and four new labels (text-based, caution sign-shaped, horizonal stoplight, vertical thermometer) which used color, symbols, and verbal strength descriptors. Participants reported on perceived addictiveness for all labels viewed and rank-ordered labels on perceived ability to convey information accurately.Results: Participants ranked the vertical (77%) and horizontal (70%) labels in first or second place and mg/mL (59.1%) and percent (47.2%) in last or second-to-last place. All new labels conveyed nicotine strength more accurately than did market labels (M[SD] correct of 6: percent = 1.50[1.08]; mg/mL = 2.14[1.52]; caution = 5.23[1.37]; vertical thermometer = 5.28[1.51]; text = 5.33[1.36]; horizontal stoplight = 5.47[1.14]), with the horizontal label also outperforming the thermometer and caution labels. Underestimating nicotine strength was uncommon among all new labels (4.7-6.8%). The new labels also were associated with increased perceived addictiveness at higher concentrations (30, 40, and 50 mg/mL), although the thermometer label underperformed the others. When considering perceived nicotine strength, rates of strength underestimates, perceived addictiveness, and rank ordering, the horizontal stoplight label performed best.Conclusions: Novel labeling could improve understanding of nicotine strength and e-cigarette-related risk.Implications: Extending prior research showing that adolescents and young adults who use Electronic Nicotine Delivery Systems (ENDS) have difficulty understanding nicotine concentrations labeled using mg/mL and percent nicotine, the current study demonstrates that novel nicotine concentration labels can improve understanding of nicotine strength and influence perceptions of addictiveness among young ENDS users. While four novel labels were tested, each outperforming current market labeling, the novel label that resembles a horizontal stoplight performed best. The study provides proof-of-concept that creating an easy-to-understand nicotine concentration label is possible and that new labeling better conveys information about nicotine strength and addictiveness. [ABSTRACT FROM AUTHOR]

Introduction: Adolescence represents a critical period in which nicotine dependence (ND) symptoms are developing. Little is known about waterpipe (WP) smoking and developmental trajectories of ND criteria across adolescence.Aims and Methods: Here, we aimed to identify ND trajectories from early- to late-adolescence in current (past 30 days) WP smokers and examine baseline correlates of each identified trajectory, using the International Classification of Diseases, 10th Revision (ICD-10). The analytical sample consisted of 278 current WP smokers from eight waves of an ongoing longitudinal cohort of eighth to ninth graders in Lebanon. Group-based trajectory modeling was estimated to identify trajectory classes for ICD-10-ND criteria over ages 11-18.Results: A group-based modeling approach yielded a four-class solution that best fit the data and reflected differences in the timing of ND onset during adolescence: no-onset of ND (43.9%), early-onset (16.2%), mid-onset (26.6%), and late-onset (13.3%) of ND criteria. Having a less-educated mother (adjusted odds ratio [aOR] = 4.08, 95% confidence interval [95% CI] = 1.01% to 16.53%) and siblings who smoke WP (aOR = 3.95, 95% CI = 1.08% to 14.42%), exposure to favorite WP-specific advertisements (aOR = 3.33, 95% CI = 1.03% to 10.85%), and being a novelty seeker (aOR = 1.12, 95% CI = 1.02% to 1.23%) were associated with early-onset of ND. Daily (aOR = 3.48, 95% CI = 1.08% to 11.23%) or weekly (aOR = 2.20, 95% CI = 1.05% to 4.62%) WP smokers (vs. monthly) and having higher stress level (aOR = 1.07, 95% CI = 1.00% to 1.14%) were associated with mid-onset trajectory. Believing that WP smoking is not harmful to health (aOR = 0.11, 95% CI = 0.02% to 0.82%) and spending less than 60 minutes on a WP smoking session (aOR = 5.62, 95% CI = 1.20% to 26.44%) were associated with late-onset ND trajectory class.Conclusions: Monitoring the development of ND trajectories among WP smokers may identify an individual as belonging to one of these four groups with distinct individual and socioenvironmental factors and allow the individual and health care providers opportunities to inform initiate on-time WP-specific tailored prevention and cessation interventions.Implications: The results from this study showed a four-class trajectory of ICD-10-ND criteria and suggested that every ND trajectory class during adolescence could have distinctive characteristics and therefore provides new insights into the process of ND in terms of when and what specific interventions are needed to curb the development of ND and long-term WP smoking among youth. [ABSTRACT FROM AUTHOR]

Background and Aims: The province of Ontario, Canada, banned the use of menthol-flavored tobacco products as of January 1, 2017. This study aims to assess the longer-term impact of a menthol ban on smoking behavior at 2 years, which is unknown.Methods: Population cohort study with baseline survey (n = 1821) conducted September-December 2016 and follow-up survey January-August 2019 among current smokers in Ontario (16+) prior to the menthol ban. Poisson regression was used to assess the probability of quitting smoking by pre-ban menthol status, controlling for differences in smoking and demographic characteristics, with multiple imputations used to address missing data.Findings: Menthol smokers were more likely to report having quit smoking (12% [daily menthol] and 10% [occasional menthol] vs. 3% [non-menthol]; p < .001) than non-menthol smokers in the 2 years after a menthol ban. After adjustment for smoking and demographic characteristics, daily menthol smokers had higher likelihood of quitting smoking (adjusted relative risk [ARR] 2.08; 95% confidence interval [CI] 1.20-3.61) and reported more quit attempts (ARR 1.45; 95% CI 1.15-1.82). Among those who attempted to quit, menthol smoking was not associated with relapse (daily ARR = 0.96; 95% CI: 0.86, 1.07; occasional ARR = 0.99; 95% CI: 0.90, 1.08). However, there was a statistically significant interaction among menthol users who reported using other flavored tobacco products 1 year after the ban (ARR = 0.26 [95% CI: 0.08, 0.90]).Conclusions: The study found increased probability of quitting among daily menthol smokers and more quit attempts among daily and occasional menthol smokers compared with non-menthol smokers in Ontario 2 years after the implementation of a menthol ban.Implications: This study examines quitting behavior 2 years after a menthol ban in Ontario, Canada. Those who were daily menthol smokers prior to the ban were more likely to quit smoking and make more quit attempts in the 2 years after the ban. While there was no difference in the likelihood of relapse between menthol and non-menthol smokers among those who attempt to quit, there were indications that pre-ban daily menthol smokers who used other tobacco products after the ban were likely to quit. [ABSTRACT FROM AUTHOR]

Introduction: E-cigarette e-liquid nicotine concentrations typically are labeled as mg/mL or percent nicotine. We examined whether these metrics accurately convey nicotine strength to young e-cigarette users and if youth can compare concentrations presented in mg/mL and percent nicotine.Aims and Methods: Eight hundred and twenty-one adolescent and young adult e-cigarette users participated in the survey. Participants rated nicotine concentration strengths presented as mg/mL (0-60 mg/mL) and percent nicotine (0%-6%) from "no nicotine" to "very high nicotine." Participants also viewed pairs of nicotine concentrations (eg, 18 mg/mL vs. 5%) and indicated which concentration was stronger or if the concentrations were equivalent.Results: On average, participants correctly identified 5.92 (2.68) of 18 nicotine strengths, correctly identifying strengths labeled as mg/mL (3.47 [2.03]) more often than percent nicotine (2.45 [1.38], p < .001). Excluding nicotine-free, participants rated concentrations presented as mg/mL as stronger, more addictive, and more harmful than equivalent concentrations presented as percent nicotine. Participants seldom correctly identified that one concentration was stronger or that both were equivalent (7.58 [5.88] of 19 pairings), although they more often correctly identified the stronger concentration when it was presented in mg/mL (4.02 [SD = 3.01]) than in percent nicotine (2.53 [2.73], p < .001). The most consistent predictor of correct answers on these tasks was familiarity with using both products labeled as mg/mL and labeled as percent nicotine.Conclusions: Young e-cigarette users had difficulty understanding nicotine concentrations labeled using the most common metrics, raising concerns about inadvertent exposure to high nicotine levels and suggesting that a more intuitive labeling approach is needed.Implications: This study extends prior work showing that young e-cigarette users often are uncertain whether the e-liquids they use contain nicotine by demonstrating that adolescents and young adults have difficulty understanding nicotine concentrations labeled using the two most common metrics (mg/mL and percent nicotine). Errors generally underestimated nicotine strength, and users were not able to accurately compare nicotine concentrations presented as mg/mL and percent nicotine. Difficulty understanding labeling metrics persisted even after accounting for user characteristics like age and vaping experience, suggesting that a novel, easy to understand labeling system is needed to convey information about nicotine strength accurately. [ABSTRACT FROM AUTHOR]

Introduction: In 2018, the United States Food and Drug Administration (FDA) required that electronic cigarette (e-cigarette) manufacturers, packagers, importers, distributors, and retailers display an addictive or alternate warning statement on e-cigarette visual advertisements. Few studies have investigated the FDA-mandated and other warnings on social media. This study examined the prevalence and content of warning statements in e-cigarette-related YouTube videos.Methods: In 2019, The Virginia Commonwealth University Center for the Study of Tobacco Products conducted bi-monthly (February-June) YouTube searches by relevance and view count to identify e-cigarette-related videos. Overall, 178 videos met the inclusion criteria. Staff coded each video for the presence of a visual/verbal warning statement, warning statement type (eg, FDA-mandated, addiction/tobacco, safety/toxic exposure, health effects), sponsorship, and tobacco product characteristics. A data extraction tool collected the video URL, title, upload date, and number of views, likes/dislikes, and comments.Results: Only 5.1% of videos contained FDA-mandated and 21.9% contained non-mandated warnings. All videos with FDA-mandated and 46.2% of non-mandated warnings were represented visually. Only 13.1% of industry-sponsored videos uploaded after the mandate effective date had an FDA-mandated warning statement and videos with FDA-mandated and non-mandated (v. no) warnings had significantly fewer views, likes, dislikes, and comments. Among all non-mandated warnings, 31.3% featured an addiction/tobacco, 18.8% a safety/toxic exposure, and 37.5% a health effects warning.Conclusions: The prevalence of FDA-mandated warning statements in e-cigarette related YouTube videos was low. FDA enforcement of the warning statement mandate on YouTube could increase the public's understanding of the addictive nature of nicotine in e-cigarettes.Implications: The FDA has the authority to regulate the advertisement and promotion of e-cigarettes on the Internet. These data can inform future FDA requirements related to the language content and visual representation of addiction/tobacco, safety/exposure, and health effects warning statements that appear in YouTube videos and other visual social media popular among young people. Such data would help consumers make informed decisions about purchasing e-cigarette products, using e-cigarettes, and avoiding unintentional harm related to e-cigarettes. In addition, these data may help social media platforms make decisions on whether they will prohibit advertisements that promote or facilitate the sale of tobacco products. [ABSTRACT FROM AUTHOR]

Introduction: Although some smokers switch to exclusive use of electronic cigarettes (e-cigarettes), others become dual users of combustible cigarettes and e-cigarettes. Little is known about how the onset of vaping affects the use of and dependence on combustible cigarettes or total nicotine use and dependence, which may influence health-related and cessation outcomes. Using self-report data of current combustible and e-cigarette use and retrospective recall of pre-vaping smoking in a sample of dual users, the aims of this study were (1) to compare pre- and post-vaping number of cigarettes per day and combustible cigarette dependence; (2) to compare pre- and post-vaping total nicotine use frequency (number of vaping sessions and cigarettes smoked per day), and total nicotine dependence; and (3) to examine predictors of nicotine dependence.Methods: We used baseline data from a smoking cessation trial with 2896 dual users. Nicotine use frequency and the Heaviness of Smoking Index were used as measures of nicotine use and dependence, respectively.Results: Participants decreased cigarettes/day from pre- (M = 19.24, SD = 9.01) to post-vaping (M = 11.15, SD = 8.02, p < .0001) and combustible cigarette dependence declined from pre- (M = 3.55, SD = 1.51) to post-vaping (M = 2.11, SD = 1.60, p < .0001). Total daily nicotine use frequency increased after initiating vaping (M = 19.25, SD = 9.01 vs. M = 29.46, SD = 8.61; p < .0001), as did total nicotine dependence (M = 3.55, SD = 1.51 vs. M = 4.68, SD = 1.38; p < .0001). Hierarchical regression analyses indicated that variables associated with greater overall nicotine dependence included: younger age, lower education, more years smoking, higher pre-vaping nicotine dependence, using e-cigarettes more days per month, more puffs per vaping session, higher e-liquid nicotine concentration, and longer vaping history.Conclusions: Dual use leads to a reduction in the number of combustible cigarettes, but total nicotine use and dependence increases.Implications: In dual users, a reduction in smoking following onset of vaping may offer some harm reduction via reduction in cigarette intake. However, the increase in total nicotine use and dependence could affect the ability to quit either or both products. [ABSTRACT FROM AUTHOR]

Background: The United States Food and Drug Administration has prioritized understanding the dependence potential of electronic cigarettes (e-cigs). Dependence is often estimated in part by examining frequency of use; however measures of e-cig use are not well developed because of varying product types. This study used an e-cig automatic puff counter to evaluate the value of self-reported e-cig use measures in predicting actual use (puffs).Methods: Data were collected from a two-site randomized placebo-controlled trial evaluating the effects of e-cigs on toxicant exposure in smokers attempting to reduce their cigarette consumption. Participants randomized to an e-cig condition self-reported their e-cig frequency of use (times per day-one "time" consists of around 15 puffs or lasts around 10 minutes) on the Penn State Electronic Cigarette Dependence Index (PSECDI) and kept daily diary records of the number of puffs per day from the e-cig automatic puff counter. A linear mixed-effects model was used to determine the predictive value of the times per day measure. Correlations were used to further investigate the relationship.Results: A total of 259 participants with 1165 observations of e-cig use were analyzed. Self-reported e-cig use in times per day was a significant predictor of e-cig puffs per day (p < .01). The Spearman correlation between measures was r equal to .58. Examination of individual participant responses revealed some potential difficulties reporting and interpreting times per day because of the difference in use patterns between cigarettes and e-cigs.Conclusion: This study provides evidence that the self-reported PSECDI measure of times per day is a significant predictor of actual frequency of e-cig puffs taken.Implications: Self-reported measures of e-cig frequency of use are predictive of actual use, but quantifying e-cig use in patterns similar to cigarettes is problematic. [ABSTRACT FROM AUTHOR]

Introduction Relative to non-waterpipe (WP) smokers, WP smokers are more than twice as likely to use alcohol and frequently consume alcohol before or during smoking sessions. Co-use of alcohol and WP may result in greater toxicant exposure compared to WP smoking alone. To date, no study systematically has investigated the impact of acute alcohol intoxication on WP smoking topography, exposure to tobacco-related toxicants, or abuse liability. Methods Dyads of current WP smokers and drinkers (N = 42; age = 21–32 years) completed two in-laboratory ad libitum smoking sessions (≤2 hours) following 12-hour nicotine abstinence in a double-blind, randomized crossover design in which they consumed a placebo versus active drink (sustained breath alcohol concentration =.08). Exhaled carbon monoxide (eCO) and plasma nicotine concentration were assessed. Questionnaires assessed smoking experience and smoking urge. Smoking topography was measured continuously throughout each smoking session. Results The alcohol session was associated with increased inhaled volume, flow rate, and WP session duration compared to placebo. Compared to placebo, participants reported a more positive overall smoking experience following the alcohol session and greater smoking urges pre- and post-smoking session. Although both sessions resulted in significant increases in eCO and plasma nicotine, no significant differences emerged in eCO or nicotine exposure between the active and placebo sessions. Conclusions Co-use of alcohol and WP may contribute to the maintenance of WP smoking through enhanced smoking experiences, increased urge to smoke, and significant exposure to addictive nicotine. Regulations may be necessary to limit the sale of alcohol in WP smoking lounges and reduce exposure to secondhand smoke. Implications The findings suggest co-use of alcohol and WP tobacco likely maintain WP use and dependence by enhancing the smoking experience and increasing urges to smoke. These findings have implications for regulations aimed at limiting co-use of alcohol and WP tobacco in WP lounges and limiting exposure to secondhand smoke. Clinical trials registration NCT03096860 [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Introduction: Open electronic cigarette (e-cigarette) systems are customizable by consumers and often allow for potential "unorthodox" use of the product; that is, use not as intended by the manufacturer. Little is known about the types and prevalence of unorthodox uses and how these practices are transmitted via popular social media.Methods: Monthly searches of YouTube were conducted from June through November 2016 using the following search terms: "e-cigarettes," "vaping," and "e-juice." After collecting static and dynamic data on the 150 videos identified, two coders independently coded videos for general information, unorthodox use behaviors, health claims, and production quality and characteristics for orthodox and unorthodox use. Intercoder reliability was high (Cohen's κ 0.81, p < .001).Results: One hundred fifty videos were included in the study with a total of 115 551 563 views. We identified nine categories of unorthodox uses of e-cigarettes. Unorthodox use was three times as prevalent as orthodox use. Seventy-seven percent of the unorthodox use videos included recreational e-cigarette use, 57% included modification of mechanical parts and components, and 44.6% included unorthodox substance application (dripping). There were more than twice as many social media links in videos depicting unorthodox compared to orthodox use, but the level of engagement was lower for unorthodox use.Conclusions: E-cigarette unorthodox use on YouTube is more prevalent than orthodox use, suggesting the need to further investigate the prevalence of unorthodox use among e-cigarette users and the influence of social media on consumer uptake of unorthodox and orthodox uses of e-cigarettes.Implications: The US Food and Drug Administration has regulatory authority over e-cigarettes, parts and components. Many e-cigarettes currently marketed are open systems. Closed systems may allow less manipulation and may influence the safety of these products. This study provides valuable information on ways that open system e-cigarettes are used and it can inform safety tests that can be conducted by the US Food and Drug Administration to determine whether or not these products should remain on the market. In addition, our definitions of unorthodox use can be incorporated into the Population Assessment of Tobacco on Health Study to better understand the prevalence of these behaviors. [ABSTRACT FROM AUTHOR]

Introduction: Flavored waterpipe (WP) tobacco is the main type of tobacco used by young WP smokers, and a major factor attracting youth to smoke. However, evidence regarding the effect of limiting flavor on WP smokers' experience continues to be lacking. This study aims at evaluating the effect of flavor restriction on WP smokers' toxicant exposure, smoking topography, subjective experiences and harm perception.Methods: Thirty-two WP smokers completed two, 45-minute ad libitum smoking sessions (preferred flavor vs non-flavored tobacco) in a crossover design pilot study. Plasma nicotine concentration and exhaled carbon monoxide (eCO) were measured before and after each smoking session. Puff topography was recorded throughout the smoking session. Participants completed survey questionnaires assessing subjective smoking experiences and harm perception.Results: Significant differences were observed in plasma nicotine concentration between the two WP tobacco conditions, with a higher increase in plasma nicotine concentration following the flavored tobacco session. There were no significant differences between the two WP tobacco conditions for eCO and smoking topography measures. Compared with the non-flavored WP tobacco, we documented enhanced subjective smoking measures of satisfaction, calmness, taste, puff liking and enjoyment following the preferred flavored WP tobacco session. Cigarette harm perception was significantly higher among participants after smoking their preferred flavor compared with non-flavored WP tobacco.Conclusions: Limiting tobacco flavor has a substantial effect on WP smokers' nicotine exposure, subjective experience and harm perception. Therefore, eliminating or restricting WP flavors could be an essential element of comprehensive tobacco control policies to reduce the appeal of WP tobacco products for youth.Implications: This study highlights the important role of flavor in shaping WP smokers' experiences and exposures and the potential impact that regulating flavored WP tobacco may have on curbing WP use among youth in the US. Such regulations may reduce the appeal and the interest in WP smoking initiation and continued use. [ABSTRACT FROM AUTHOR]

Introduction: Prior to the US Food and Drug Administration's (FDA) regulation of electronic cigarettes and warning statements related to nicotine addiction, there was no critical examination of manufacturer/distributor voluntary practices that could potentially inform FDA actions aimed to protect consumers. This study examined the content of warning statements and safety characteristics of electronic cigarette liquid bottles using a national sample.Methods: Research staff randomly selected four electronic cigarette liquid manufacturers/distributors from four US geographic regions. Staff documented the characteristics of product packaging and content of warning statements on 147 electronic cigarette liquids (0-30 mg/ml of nicotine) purchased online from 16 manufacturers/distributors in April of 2016.Results: Data showed that 97.9% of the electronic cigarette liquid bottles included a warning statement, most of which focused on nicotine exposure rather than health. Only 22.4% of bottles used a warning statement that indicated the product "contained nicotine." Of bottles that advertised a nicotine-based concentration of 12 mg/ml, 26% had a warning statements stated that the product "contains nicotine." None of the statements that indicated that the product "contained nicotine" stated that nicotine was "addictive." All bottles had a safety cap and 12% were in plastic shrink-wrap. Fifty-six percent of the websites had a minimum age requirement barrier that prevented under-aged persons from entering.Conclusions: Most manufacturers/distributors printed a warning statement on electronic cigarette liquid bottles, but avoided warning consumers about the presence and the addictiveness of nicotine. Studies are needed to examine manufacturer/distributor modifications to product packaging and how packaging affects consumer behaviors.Implications: These data can inform future FDA requirements related to the packaging and advertising of e-cigarette liquids; regulation related to the content of warning statements, including exposure warning statements, which are not currently mandated; and requirements on websites or language on packaging to help manufacturers adhere to the minimum age of purchase regulation. The data can also be used to help FDA develop additional guidance on the framing of statements on packaging that helps consumers make informed decisions about purchasing the product or protecting young people from use or unintentional exposure to the product. [ABSTRACT FROM AUTHOR]

Introduction: Waterpipe tobacco smoking has increased in prevalence worldwide, including among pregnant women. In this study, we investigated the effect of prenatal maternal waterpipe tobacco smoke (WTS) exposure during different stages of pregnancy on learning and memory of adult offspring rats.Methods: Pregnant rats received either fresh air or mainstream WTS (2 hours daily) during early, mid, late, or whole gestational period. Male offspring rats were followed through 20 weeks. Outcomes included (1) spatial learning and memory using the radial arm water maze (RAWM), (2) levels of brain derived neurotrophic factor (BDNF) in the hippocampus, and (3) oxidative stress biomarkers (superoxide dismutase, catalase, glutathione peroxidase and thiobarbituric acid reactive substances).Results: Relative to offspring whose mothers were exposed to fresh air, prenatal exposure to WTS at any stage of pregnancy resulted in short- and long-term memory impairment in adult offspring rats (p < .05). This impairment was associated with reduced levels of BDNF in hippocampus (p < .05). However, prenatal WTS did not affect the level of oxidative stress biomarkers in hippocampus. Prenatal WTS during late gestation increased the activity of catalase as compared to control.Conclusion: Prenatal maternal WTS exposure can impair the memory of adult male offspring. These results support development of interventions that target pregnant women who smoke waterpipe during pregnancy.Implications: We examined for the first time the effect of prenatal waterpipe tobacco smoke exposure on learning and memory of offspring. The results showed that in utero exposure to waterpipe tobacco smoke was associated with impaired memory and decreased brain derived neurotrophic factor in hippocampus of adult male offspring rats. [ABSTRACT FROM AUTHOR]

Background: Electronic cigarettes (ECs) can influence nicotine addiction by delivering aerosolized nicotine. We investigated if nicotine from ECs is delivered to the brain β2*-nicotinic acetylcholine receptors (β2*-nAChR) and how this relates to the behavioral effects and nicotine delivery from cigarettes.Methods: Seven nicotine users participated in positron emission tomography (PET) studies with (-)-[18F]Flubatine before and after nicotine challenge with 0, 8, and 36 mg/ml nicotine in a 3.3 Volt, 1.5 Ohm EC or a standard tobacco cigarette. Craving was evaluated before and after product use.Results: Average β2*-nAChR occupancy was higher after 36 mg/ml EC challenge compared to 8 mg/ml EC at trend level. Average β2*-nAChR occupancy after tobacco cigarette smoking was 68 ± 18% and was not different compared with 8 mg/ml (64 ± 17%,) or 36 mg/ml (84 ± 3%) nicotine in EC users. Area under the curve (AUC) of blood nicotine level was higher in the cigarette smoking group compared with the 8mg/ml group (p = 0.03), but similar compared with the 36 mg/ml EC (p = 0.29). Drug craving was reduced after use of the tobacco cigarette, 8 mg/ml EC, and 36 mg/ml EC.Conclusions: In this novel investigation of EC effects at β2*-nAChRs, we show that average β2*-nAChR occupancy was higher after 36 mg/ml EC challenge compared with 8 mg/ml EC. Receptor occupancy and arterial blood nicotine levels after cigarette smoking were similar to 36 mg/ml EC use under controlled conditions. These findings suggest that the ECs studied here have abuse liability and may provide an adequate alternative nicotine delivery system for cigarette smokers.Implications: This is the first study to directly determine the neurologic effects of electronic cigarettes on human brain beta-2 nicotinic acetylcholine receptors using PET neuroimaging with (-)-[18F]Flubatine, a novel radiotracer. Our findings suggest that the e-cigarettes studied here have abuse liability and may provide an adequate alternative nicotine delivery system for cigarette smokers. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Introduction: Waterpipe tobacco smoking is a global health concern. Laboratory research has focused on individual waterpipe users while group use is common. This study examined user toxicant exposure and smoke toxicant yield associated with individual and group waterpipe smoking.Methods: Twenty-two pairs of waterpipe smokers used a waterpipe individually and as a dyad. Before and after smoking, blood was sampled and expired carbon monoxide (CO) measured; puff topography was recorded throughout. One participant from each pair was selected randomly and their plasma nicotine and expired air CO concentrations were compared when smoking alone to when smoking as part of a dyad. Recorded puff topography was used to machine-produce smoke that was analyzed for toxicant content.Results: There was no difference in mean plasma nicotine concentration when an individual smoked as part of a dyad (mean = 14.9 ng/ml; standard error of the mean [SEM] = 3.0) compared to when smoking alone (mean = 10.0 ng/ml; SEM = 1.5). An individual smoking as part of as a dyad had, on average, lower CO (mean = 15.8 ppm; SEM = 2.0) compared to when smoking alone (mean= 21.3 ppm; SEM = 2.7). When two participants smoked as a dyad they took, on average, more puffs (mean = 109.8; SEM = 7.6) than a singleton smoker (mean = 77.7; SEM = 8.1) and a shorter interpuff interval (IPI; dyad mean = 23.8 seconds; SEM = 1.9; singleton mean = 40.8 seconds; SEM = 4.8). Higher concentrations of several toxicants were observed in dyad-produced smoke.Discussion: Dyad smoking may increase smoke toxicant content, likely due to the dyad's shorter IPIs and greater puff number. More work is needed to understand if group waterpipe smoking alters the health risks of waterpipe tobacco smoking.Implications: This study is the first to measure toxicants in smoke generated from a waterpipe when used by a dyad. Relative to smoke generated by a singleton, dyad smoke had higher concentration of some toxicants. These differences may be attributed to differences in puffing behavior, specifically the shorter IPI and greater puff number observed in the dyad condition. Relative to singleton smokers, dyad smokers were exposed to less CO, but nicotine exposure did not differ. More work is needed to assess the health effects of inhalation of more toxicant-laden smoke during group waterpipe use. [ABSTRACT FROM AUTHOR]

Introduction: Increased consumption of little cigars and cigarillos (LCCs) among late adolescent and young adult African American smokers is an emerging public health concern. Despite a growing body of epidemiological evidence, there is scant research on systematic variations in LCC use among young adult African Americans. This study aimed to disaggregate African American Black & Mild (B&M) smokers and to identify subgroups of cigarillo smokers' behaviors and associated characteristics.Methods: Using telephone screening data for a NIH-funded clinical laboratory study of toxicant exposure associated with B&M use, latent class analysis (LCA) was used to classify 331 African American B&M smokers' based on daily use, average daily consumption, preference for flavors, preference for product design tips, and product modification behaviors.Results: Results showed five classes, three of which (Daily-Hypers, Daily-Flavored, and Heavy-Daily-Hypers) reflected daily use and average daily consumption rate ranging between 2.7 and 8.9 B&M cigarillos per day. Non-Daily-Hypers and Non-Daily-Flavored classes represented non-daily use patterns and averaged less than 1.0 B&M cigarillo per day. Both sets of classes defined by daily users and non-daily users included smokers who preferred flavored tobacco and who practiced product modification techniques involving hyping and blunting.Conclusions: Latent class analysis is a useful method to detect subtle differences in B&M product preferences and smoking behaviors among African Americans. Study findings highlight the importance of developing tailored interventions that consider within group differences in order to reduce the prevalence of cigarillo smoking among those with the greatest burden.Implications: The current study is the first to identify unique subgroups of African American B&M smokers based on cigarillo use behaviors and associated characteristics. Latent class analyses may prove useful for understanding other subgroups of tobacco users. Current findings concerning patterns of LCC use illustrate how future tobacco cessation and prevention interventions may be tailored for African American smokers. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Introduction: In recent years, waterpipe tobacco smoking has been increasing in popularity all over the world. In this study, we explored effects of waterpipe smoking on pregnancy outcomes in rats.Methods: Animals were exposed to waterpipe tobacco smoking using a whole body exposure system 2 hours per day during pregnancy. A control group was exposed to fresh air only.Results: The results showed significant association between exposure to waterpipe smoke during pregnancy and low birth weight (P < .01) and neonatal death (P < .01). In addition, the rate of growth of offspring of the waterpipe group was significantly lower than that of control group as measured by body weight gain during the first 3 months of life (P < .001). No effect was found for waterpipe smoking on mean number of progeny and male to female ratio among offspring.Conclusion: Waterpipe smoking is associated with adverse effects on pregnancy outcomes.Implications: In this study, we investigated for the first time the effect of waterpipe smoking on pregnancy outcomes using animal model. The results clearly showed that waterpipe smoking is associated with adverse effects on pregnancy outcomes that include low birth weigh, neonatal survival, and growth retardation. [ABSTRACT FROM AUTHOR]

Introduction: Cigars remain a widely used tobacco product among adolescent and adult populations. The appeal of a certain type of cigar, the cigarillo, may be enhanced by users' beliefs that their harm potential can be reduced by removing the inner tobacco liner before use (a.k.a. "hyping"). The purpose of this within-subject study was to compare the acute effects of smoking an original cigarillo, a modified ("hyped") cigarillo, and an unlit cigarillo.Methods: Twenty smokers (19 males, 1 female; 19 non-Hispanic blacks, 1 Hispanic "other") of at least 7 Black&Mild (B&M) cigarillos/week and at most 5 cigarettes/day completed the study. All participants reported hyping their cigarillos at least occasionally. Primary outcomes, assessed over two, 30-minute smoking bouts, included plasma nicotine, expired air carbon monoxide (CO) concentration, subjective ratings (product effects, nicotine abstinence symptoms), and puff topography.Results: Mean plasma nicotine concentration increased significantly within (pre- to post-bouts), but not between, original and modified B&M conditions. Mean CO concentration was significantly lower for modified, relative to original, B&M smoking at all post-administration timepoints. Both smoked conditions significantly increased ratings of positive product effects (satisfaction, pleasant) and decreased abstinence symptom magnitude; however, ratings generally did not differ between these conditions. Overall, topography outcomes did not differ between modified and original B&M smoking.Conclusions: Results are consistent with a previous report in that "hyping" may decrease users' CO, but not nicotine, exposure. While these data collectively suggest reduced exposure to CO acutely with engagement in "hyping," longer-term assessments are needed to determine the impact on individual and public health. [ABSTRACT FROM AUTHOR]

Introduction: Clinical laboratory work among intermittent and daily waterpipe tobacco smokers has revealed significant risks for tobacco dependence and disease associated with waterpipe tobacco smoking (WTS). No studies have compared these groups directly. This study examined whether WTS frequency was associated with differential puff topography, toxicant exposure, and subjective response using a placebo-control design. Methods: Eighty participants reporting WTS of 2-5 episodes (LOW; n = 63) or ≥20 episodes (HIGH; n = 17) per month for ≥6 months completed 2 double-blind, counterbalanced 2-hr sessions that were preceded by ≥12 hr of tobacco abstinence. Sessions differed by product smoked ad libitum for 45+ min: preferred brand/flavor of waterpipe tobacco (active) or a flavor-matched tobacco-free waterpipe product (placebo). Outcomes included puff topography, plasma nicotine, carboxyhemoglobin (COHb), and subjective response. Results: HIGH users had more puffs, shorter inter-puff-intervals, and a higher total puff volume for placebo relative to active, as well as relative to LOW users during placebo. Plasma nicotine concentrations increased when smoking active (but not placebo) with no significant differences between groups at 25 min post-product administration. COHb increased significantly during all conditions; the largest increase was for HIGH users when smoking placebo. There was some evidence of higher baseline scores for nicotine/tobacco nicotine abstinence symptomology. Conclusions: Higher frequency waterpipe users may be more sensitive to the effects of waterpipe smoke nicotine content. Among HIGH users, higher baseline nicotine/tobacco abstinence symptoms may indicate greater nicotine dependence. These data support continued surveillance of WTS and development of dependence measures specific to this product. [ABSTRACT FROM AUTHOR]

Electronic cigarettes (ECIGs) comprise an aerosolized nicotine delivery product category that provides consumers with probably unprecedented control over extensive features and operating conditions, allowing a wide range of nicotine yields to be obtained. Depending on the combination of such ECIG variables as electrical power input, geometry, liquid composition, and puff behavior, ECIG users can extract in a few puffs far more or far less nicotine than with a conventional combustible cigarette. These features of ECIG design and use present challenges for public health policy, central among which is the question of how to regulate nicotine delivery. In this commentary, we propose a conceptual framework intended to provide a convenient approach for evaluating and regulating the nicotine emitted from ECIGs. This framework employs nicotine flux to account for the total dose and rate at which nicotine reaches the user, 2 key factors in drug abuse liability. The nicotine flux is the nicotine emitted per puff second (e.g., mg/s) by a given ECIG design under given use conditions, and it can be predicted accurately using physical principles. We speculate that if the flux is too low, users likely will abandon the device and maintain conventional tobacco product use. Also, we speculate that if the flux is too high, individuals may suffer toxic side effects and/or the device may have higher-than-necessary abuse liability. By considering ECIG design, operation conditions, liquid composition, and puff behavior variables in combination, we illustrate how ECIG specifications can be realistically mandated to result in a target flux range. [ABSTRACT FROM AUTHOR]

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 (≥12mg/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 16.8ng/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. [ABSTRACT FROM AUTHOR]

Background: Electronic cigarettes (e-cigarettes) represent an emerging public health issue. These devices deliver nicotine along with other constituents, including flavorants, via an inhalable aerosol. Their uptake is rapidly increasing in both adults and youths, primarily among current smokers. Public debate is increasing on how these devices should be regulated and used, yet only limited peer-reviewed research exists. To develop a informed policy for e-cigarettes, their effects on human behavior, physiology, and health need to be understood. Purpose: This paper describes proceedings from a National Institutes of Health–sponsored workshop, which was held in November 2013, to identify research needs related to the effects of e-cigarettes. Discussion topics included e-cigarette risks and abuse potential; the potential role for e-cigarettes in harm reduction and smoking cessation; unintended consequences of e-cigarette use, such as becoming a gateway to conventional cigarettes; and dual use of both e-cigarettes and conventional cigarettes. Results and Conclusions: The research needs identified by the workshop participants included the following: standards to measure the contents and emissions of e-cigarettes; biomarkers of exposure; physiological effects of e-cigarettes on tissues and organ systems, including pulmonary and cardiovascular; information on e-cigarette users, how the devices are used, and identification of the best tools to assess these measures; factors that drive use and influence patterns of use; and appropriate methods for evaluating a potential role for e-cigarettes in smoking or nicotine cessation. To understand fully the challenges and the opportunities that e-cigarettes represent, expertise will be needed in basic, behavioral, translational, and clinical sciences. [ABSTRACT FROM AUTHOR]

Introduction: Some electronic cigarette (ECIG) users attain tobacco cigarette–like plasma nicotine concentrations while others do not. Understanding the factors that influence ECIG aerosol nicotine delivery is relevant to regulation, including product labeling and abuse liability. These factors may include user puff topography, ECIG liquid composition, and ECIG design features. This study addresses how these factors can influence ECIG nicotine yield. Methods: Aerosols were machine generated with 1 type of ECIG cartridge (V4L CoolCart) using 5 distinct puff profiles representing a tobacco cigarette smoker (2-s puff duration, 33-ml/s puff velocity), a slow average ECIG user (4 s, 17 ml/s), a fast average user (4 s, 33 ml/s), a slow extreme user (8 s, 17 ml/s), and a fast extreme user (8 s, 33 ml/s). Output voltage (3.3–5.2 V or 3.0–7.5 W) and e-liquid nicotine concentration (18–36 mg/ml labeled concentration) were varied. A theoretical model was also developed to simulate the ECIG aerosol production process and to provide insight into the empirical observations. Results: Nicotine yields from 15 puffs varied by more than 50-fold across conditions. Experienced ECIG user profiles (longer puffs) resulted in higher nicotine yields relative to the tobacco smoker (shorter puffs). Puff velocity had no effect on nicotine yield. Higher nicotine concentration and higher voltages resulted in higher nicotine yields. These results were predicted well by the theoretical model (R2 = 0.99). Conclusions: Depending on puff conditions and product features, 15 puffs from an ECIG can provide far less or far more nicotine than a single tobacco cigarette. ECIG emissions can be predicted using physical principles, with knowledge of puff topography and a few ECIG device design parameters. [ABSTRACT FROM AUTHOR]

Introduction: Electronic cigarettes (e-cigs) are becoming increasingly popular, but little is known about their dependence potential. This study aimed to assess ratings of dependence on electronic cigarettes and retrospectively compare them with rated dependence on tobacco cigarettes among a large sample of ex-smokers who switched to e-cigs. Methods: A total of 3,609 current users of e-cigs who were ex-cigarette smokers completed a 158-item online survey about their e-cig use, including 10 items designed to assess their previous dependence on cigarettes and 10 almost identical items, worded to assess their current dependence on e-cigs (range 0–20). Results: Scores on the 10-item Penn State (PS) Cigarette Dependence Index were significantly higher than on the comparable PS Electronic Cigarette Dependence Index (14.5 vs. 8.1, p < .0001). In multivariate analysis, those who had used e-cigs longer had higher e-cig dependence scores, as did those using more advanced e-cigs that were larger than a cigarette and had a manual button. Those using zero nicotine liquid had significantly lower e-cig dependence scores than those using 1–12mg/ml, who scored significantly lower than those using 13 or greater mg/ml nicotine liquid (p < .003). Conclusions: Current e-cigarette users reported being less dependent on e-cigarettes than they retrospectively reported having been dependent on cigarettes prior to switching. E-cig dependence appears to vary by product characteristics and liquid nicotine concentration, and it may increase over time. [ABSTRACT FROM AUTHOR]

The Arab world is comprised of 22 countries with a combined population of ∼360 million. The region is still at the initial stages of the tobacco epidemic, where it is expected to witness an increase in smoking levels and mounting tobacco-related morbidity and mortality in the future. Still, the bleak outlook of the tobacco epidemic in the Arab world continues to be faced with complacency in the form of underutilization of surveillance systems to monitor the tobacco epidemic and prioritize action, and failure to implement and enforce effective policies to curb the tobacco epidemic. Understandably, the focus on the Arab world carries the risk of trying to generalize to such a diverse group of countries at different level of economic and political development. Yet, tobacco control in the Arab world faces some shared patterns and common challenges that need to be addressed to advance its cause in this region. In addition, forces that promote tobacco use, such as the tobacco industry, and trends in tobacco use, such as the emerging waterpipe epidemic tend to coalesce around some shared cultural and socio-political features of this region. Generally, available data from Arab countries point at three major trends in the tobacco epidemic: (1) high prevalence of cigarette smoking among Arab men compared with women; (2) the re-emergence of waterpipe (also known as hookah, narghile, shisha, arghile) smoking as a major tobacco use method, especially among youth and (3) the failure of policy to provide an adequate response to the tobacco epidemic. In this review, we will discuss these trends, factors contributing to them, and the way forward for tobacco control in this unstable region. [ABSTRACT FROM AUTHOR]

Introduction: While the Lebanon Waterpipe Dependence Scale (LWDS-11) has shown promise in assessing dependence on waterpipe tobacco smoking (WTS) in Lebanon among adult users, it would be valuable to identify WTS addiction earlier and to explore reliability and validity of these items in other populations. Methods: In 2010–2012, we conducted a multiyear survey of 5,853 students from 4 Jordanian universities. We measured WTS, sociodemographic data, and the LWDS-11 items. We conducted exploratory factor analysis with half of the sample and confirmed the resulting model using confirmatory factor analysis with the other half. We examined construct validity with regression models assessing associations between the modified scale and 5 constructs conceptually expected to be associated with dependence. Results: WTS rates were 35% in the past 30 days and 56% ever. Principal-components analysis of LWDS items in the first half of the sample yielded 10 items representing 3 factors labeled physical dependence, relaxation/pleasure, and social aspects. Cronbach’s α was .77 for the total scale and was .75, .70, and .67 for each individual subscale. Confirmatory factor analysis in a structural equation modeling framework confirmed good fit (root mean squared error of approximation = 0.068, and comparative fit index = 0.937). Dependence according to the resulting scale (LWDS-10J) was strongly associated with each of the 5 expected constructs, whether the dependent variable was treated as categorical or continuous. Conclusions: The LWDS-11 items exhibited a different factor structure in our sample. However, the modified scale (LWDS-10J) showed promising reliability and construct validity in this population. [ABSTRACT FROM PUBLISHER]

Introduction: In recent years, a class of products marketed as “tobacco-free” alternatives for the “health conscious user” has become widely available for waterpipe (hookah, narghile, or shisha) smoking. Their adoption may be in part driven by regulations banning tobacco smoking in public places and by an increasing awareness of the hazards of waterpipe tobacco smoking. Although these products are presented in advertising as a “healthier” choice, very little is known about their health effects. Methods: In this study, we compared the effects of smoke generated with tobacco-free and conventional tobacco-derived products on human alveolar cells. Smoke was generated with a smoking machine that precisely mimicked the puffing behavior of 15 experienced waterpipe smokers when they used conventional waterpipe tobacco products of their choice and flavor-matched tobacco-free products. Human alveolar epithelial cells (A549) were treated with particulate matter sampled from the smoke, and the effects on cell cycle, proliferation, and doubling time were measured during the subsequent 72hr. Results: We found that smoke from both types of waterpipe products markedly reduced cell proliferation, caused cell cycle arrest at G0/G1, and increased cell doubling time. There were no significant differences across product in any measure. Conclusion: Tobacco-free and tobacco-based waterpipe products exert substantial and similar deleterious effects on human lung cells. This study adds to the nascent evidence base indicating that except for exposure to nicotine and its derivatives, use of tobacco-free waterpipe products does not present a reduced health risk relative to the use of conventional tobacco-based products. [ABSTRACT FROM PUBLISHER]

Introduction: To date research on tobacco smoking with a waterpipe (hookah, narghile, and shisha) has focused primarily on the individual user in a laboratory setting. Yet, waterpipe tobacco smoking is often a social practice that occurs in cafés, homes, and other natural settings. This observational study examined the behavior of waterpipe tobacco smokers and the social and contextual features of waterpipe use among groups in their natural environment. Methods: Trained observers visited urban waterpipe cafés on multiple occasions during an 8-month period. Observations of 241 individual users in naturally formed groups were made on smoking topography (puff frequency, duration, and interpuff interval [IPI]) and engagement in other activities (e.g., food and drink consumption, other tobacco use, and media viewing). Results: Most users were male in group sizes of 3–4 persons, on average, and each table had 1 waterpipe, on average. The predominant social features during observational periods were conversation and nonalcoholic drinking. Greater puff number was associated with smaller group sizes and more waterpipes per group, while longer IPIs were associated with larger group sizes and fewer waterpipes per group. Additionally, greater puff frequency was observed during media viewing and in the absence of other tobacco use. Conclusions: Overall, the results suggest that waterpipe smoking behavior is affected by group size and by certain social activities. Discussion focuses on how these findings enhance our understanding of factors that may influence exposure to waterpipe tobacco smoke toxicants in naturalistic environments. [ABSTRACT FROM PUBLISHER]

Introduction: Waterpipe tobacco smoking involves self-administration of the dependence-producing drug nicotine. Few studies have examined if dependence in waterpipe smokers influences toxicant exposure and smoking behavior. Method: Current waterpipe tobacco smokers were categorized based on Lebanese Waterpipe Dependence Scale-11 (LWDS-11) score (LWDS-11: LOW < 7; N = 59; HIGH > 13; N = 59). Participants abstained from smoking for 12 hr and then completed a single 30-min waterpipe tobacco smoking episode. Expired-air carbon monoxide (CO) was measured before and 5 min after smoking and puff topography was measured during smoking. Results: Total mean smoking time was 30.9 min (SD = 3.5) and did not differ significantly by LWDS-11 score. CO boost was greater for participants in the HIGH versus LOW groups (62.3 vs. 43.6 ppm, p < .01). Similarly, those in the HIGH versus LOW group took more puffs (198.6 vs. 157.1 puffs, p < .01), longer duration puffs (2.7 vs. 2.3 s, p < .05), puffs with lower flow rate (10.3 vs. 12.6 L/min, p < .01), and less time between puffs (8.0 vs. 12.4 s, p < .001). Conclusion: The puff topography of waterpipe tobacco smokers can be predicted by LWDS-11 score, with those scoring higher taking longer duration and lower velocity puffs at a higher frequency. These behavioral differences may underlie the 40% greater CO exposure observed for those with higher LWDS-11 scores. To the extent that waterpipe dependence is associated with more smoke inhalation, more dependent smokers will be exposed to greater amounts of toxic smoke constituents. [ABSTRACT FROM PUBLISHER]

Introduction: Electronic cigarettes (ECs) are marketed as nicotine delivery devices. Two studies with EC-naïve participants suggest that ECs deliver little or no nicotine. In those studies, standard-sized ECs were used, though experienced EC users often use larger devices that house higher voltage and/or longer lasting batteries. Whether user experience and device characteristics influence EC nicotine delivery is uncertain. The purpose of the present study was to examine the effects of ECs in experienced users who were using their preferred devices. Methods: Eight EC users (3 women) who had been using ECs for at least 3 months, completed one 5-hr session using devices they provided and the flavor/strength nicotine cartridges they selected. Sessions consisted of 4 phases: baseline, 10 puffs (30-s interpuff interval) from the device, 1-hr ad lib puffing period, and a 2-hr rest period (no puffing). Outcome measures in each phase included plasma nicotine concentration, heart rate, and subjective ratings of nicotine/product effects and abstinence symptoms. Results: Relative to baseline, plasma nicotine and heart rate increased significantly within 5 min of the first puff and remained elevated throughout the ad lib puffing period. Increases in ratings of direct effects of nicotine and product were observed as well as decreases in abstinence symptoms. Conclusions: User experience and/or device characteristics likely influence EC nicotine delivery and other effects. Systematic manipulation of these and other variables could elucidate conditions that produce intended effects. [ABSTRACT FROM AUTHOR]

Introduction: Throughout the Eastern Mediterranean region, tobacco is used primarily in 2 forms: cigarette smoking and waterpipe smoking. Despite the fact that tobacco use is considered as a global public health threat, waterpipe smoking is reported to be growing in popularity, particularly among women. The objectives of this study are to determine the prevalence and patterns of cigarette, waterpipe, and passive smoking among pregnant women in Jordan, and to assess their perception of harmful effects of cigarette and waterpipe smoking. Methods: A total of 500 pregnant women were randomly recruited from maternity clinics in North and Middle of Jordan and surveyed regarding exposure to waterpipe tobacco and cigarette smoking. Results: The results showed that 7.9% of women were current cigarette smokers and 8.7% were current waterpipe smokers. About 82.4% of all women reported that they are exposed to cigarette smoke and 32.8% reported that they are exposed to waterpipe smoke. The most common place where women are exposed to cigarette and waterpipe smoke was their house (50.4% and 48.7%, respectively) followed by public places (31.4% and 21.4%, respectively). In addition, the husband was the main source for exposure to cigarette and waterpipe smoke (48.5% and 42.7%, respectively). Approximately, 74% of women believed that cigarette smoking is addictive, whereas only 55.1% reported that waterpipe smoking leads to addiction. Conclusions: Exposure of pregnant women to tobacco smoke is a public health problem in Jordan that requires immediate action. [ABSTRACT FROM AUTHOR]

Introduction: While cigarette use is declining, smoking tobacco with a waterpipe is an emerging trend. We aimed to determine the prevalence of waterpipe use in a large diverse sample of U.S. university students and to assess the association of waterpipe use with individual and institution-related characteristics. Methods: We assessed students from 152 U.S. universities participating in the National College Health Assessment during 2008–2009. We used multivariable regression models to determine independent associations between individual and institutional characteristics and waterpipe tobacco use in the past 30 days and ever. Results: Of 105,012 respondents included in the analysis, most were female (65.7%), White (71.2%), and attending public (59.7%) nonreligious (83.1%) institutions. Mean age was 22.1 years. A total of 32,013 (30.5%) reported ever using a waterpipe to smoke tobacco. Rates for current tobacco use were 8.4% for waterpipes, 16.8% for cigarettes, 7.4% for cigars (including cigarillos), and 3.5% for smokeless tobacco. Of current waterpipe users, 51.4% were not current cigarette smokers. Although current waterpipe use was reported across all individual and institutional characteristics, fully adjusted multivariable models showed that it was most strongly associated with younger age, male gender, White race, fraternity/sorority membership, and nonreligious institutions in large cities in the western United States. Conclusions: After cigarettes, waterpipe use was the most common form of tobacco use among university students. Because waterpipe use affects groups with a wide variety of individual and institutional characteristics, it should be included with other forms of tobacco in efforts related to tobacco surveillance and intervention. [ABSTRACT FROM AUTHOR]

The International Classification of Diseases and the Diagnostic and Statistical Manual for diagnosing tobacco/nicotine dependence emphasize the dependence-producing drug nicotine. These diagnostic tools have been challenged on grounds of poor predictive validity, and they do not differentiate across various forms of nicotine-containing products. In fact, nicotine-containing products (e.g., tobacco cigarettes, smokeless tobacco [ST], waterpipe, electronic cigarettes [ECIGs], and nicotine replacement [NR] products) have very different characteristics both in terms of sensory and behavioral involvement and also in pharmacokinetic and pharmacodynamic effects. For example, a cigarette and a nicotine patch are very different on almost every one of these dimensions. When ability to stop using a nicotine/tobacco product is used as a criterion for dependence, success rates vary considerably across products: Tobacco cigarette cessation is more difficult than ST cessation that in turn is more difficult than NR product cessation. Based on these results, we hypothesize that there is a continuum of dependence as much as there is a continuum of harm, with tobacco cigarettes and NR products on opposite ends of both continua and other products (waterpipe and ECIGs) somewhere in between. In order to capture more precisely the dependence produced by both nicotine and its administration forms, product-specific instruments may be required. The pros and cons of this approach are discussed. [ABSTRACT FROM PUBLISHER]

Introduction: Tobacco use remains a major public health problem worldwide. Water-pipe smoking is spreading rapidly and threatening to undermine the successes achieved in tobacco control. Methods: A school-based longitudinal study in the city of Irbid, Jordan, was performed from 2008 to 2010. All seventh-grade students in 19 randomly selected schools, out of a total of 60 schools in the city, were enrolled at baseline and surveyed annually. Results: Of the 1781 students enrolled at baseline 1,701 (95.5%) were still in the study at the end of the second year of follow-up (869 boys, median age at baseline 13 years). Ever and current water-pipe smoking were higher than those of cigarette smoking at baseline (ever smoking: 25.9% vs. 17.6% and current smoking: 13.3% vs. 5.3% for water-pipe and cigarette smoking, respectively; p < .01 for both) but cigarette smoking caught up by the second year of follow-up (ever smoking: 46.4% vs. 44.7%; p = .32 and current smoking: 18.9% vs. 14.9%; p < .01). Water pipe–only smokers at baseline were twice as likely to become current cigarette smokers after 2 years compared with never smokers (relative risk (RR) = 2.1; 95% CI = 1.2, 3.4). A similar pattern was observed for cigarette-only smokers at baseline (RR = 2.0; 95% CI = 0.9, 4.8). Conclusions: Prevalence of water-pipe and cigarette smoking increased dramatically over the 2-year follow-up period with similar patterns in boys and girls, although girls had lower prevalence in all categories. Water-pipe smoking at baseline predicted the progress to cigarette smoking in the future and vice versa. [ABSTRACT FROM PUBLISHER]

Introduction: Cigarillo smoking likely exposes users to many of the same toxicants (e.g., nicotine, carbon monoxide [CO]) as cigarette smoking. Yet, few controlled clinical laboratory studies evaluating of the effects of cigarillos exist. This study evaluated the cardiovascular response, toxicant exposure, subjective effects, and puffing topography of a popular cigarillo brand, Black & Mild (B&M). Methods: Sixteen B&M smokers (M ± SD = 1.9 ± 2.5 cigarillos/day for 3.4 ± 3.5 years) participated in 2 counterbalanced conditions: lit (ACTIVE) or unlit (SHAM) B&M in which they completed two 10-puff smoking bouts (30-s interpuff intervals). Results: Plasma nicotine concentrations for ACTIVE increased significantly from pre-smoking (M ± SEM = 2.0 ± 0.0 ng/ml) to 5 min after Bouts 1 (5.3 ± 0.8 ng/ml) and 2 (4.9 ± 0.9 ng/ml) but did not increase above 2.0 ± 0.0 ng/ml at any timepoint for SHAM. Heart rate increased significantly from pre- to post-smoking for ACTIVE but not for SHAM. Average expired-air CO levels, collapsed across time, were 14.3 ± 0.8 ppm for ACTIVE and 4.5 ± 0.2 ppm for SHAM. Neither condition reduced symptoms of nicotine/tobacco abstinence reliably, although ratings for some measures were significantly lower for ACTIVE than for SHAM. ACTIVE, but not SHAM, produced a variety of positive effects related to product sensory characteristics (e.g., “satisfying,” “pleasant”). Smoking topography did not differ across the two conditions. Conclusions: Ten puffs from a B&M cigarillo deliver active doses of nicotine and considerable amounts of CO but do not suppress abstinence-induced withdrawal symptoms reliably. The nicotine delivery profile suggests that cigarillo smoking may promote nicotine/tobacco dependence and the CO exposure likely poses significant health risks. [ABSTRACT FROM PUBLISHER]

Introduction: The spread of waterpipe tobacco use among youth may be due in part to perceptions that waterpipe tobacco use is safer than other tobacco products, such as cigarettes. In two pilot studies, we sought to modify college waterpipe smokers’ perceived risks and worry about waterpipe tobacco smoking. Methods: We conducted two web-based studies that varied whether college waterpipe users received information on (a) spread of and use of flavored tobacco in waterpipe and (b) harms of waterpipe smoking. Study 1 (N = 91) tested the “incremental” effects on perceptions of risk and worry of adding information about harms of waterpipe smoking to information on the spread of waterpipe and use of flavorings in the tobacco. Study 2 (N = 112) tested the effects on perceptions of risk and worry of reviewing information about harms of waterpipe smoking compared to a no information control group. In Study 1 only, we assessed as part of a 6-month follow-up (n = 70) the percentage of participants who reported no longer using waterpipe. Results: Pooling data from both studies, participants who received information about the harms of waterpipe smoking reported greater perceived risk and worry about harm and addiction and expressed a stronger desire to quit. In Study 1, 62% of participants in the experimental group versus 33% in the control group reported having stopped waterpipe use. Conclusions: These are the first studies to show that perceptions of addiction and harm from waterpipe use can be modified using minimally intensive interventions; such interventions show promise at decreasing waterpipe use. [ABSTRACT FROM AUTHOR]

Introduction: Waterpipe tobacco smoking is increasing worldwide and is believed by many users to be less harmful and addictive than cigarette smoking. In fact, waterpipe tobacco and cigarette smoke contain many of the same chemicals, and users are exposed to the dependence-producing drug nicotine as well as other smoke toxicants. The subjective effect profile of these 2 tobacco use methods has not been compared directly, though this information is relevant to understanding the risk of dependence development. Methods: Fifty-four participants who reported waterpipe and cigarette smoking completed 2, 45-min, counter-balanced sessions in which they completed a waterpipe use episode (mean smoking time = 43.3 min) or a cigarette (mean = 6.1 min). Outcome measures included plasma nicotine, carboxyhemoglobin (COHb), and subjective effects, including those relevant to predicting dependence potential. Results: Mean (±SEM) peak plasma nicotine concentration did not differ by session (waterpipe = 9.8 ± 1.0 ng/ml; cigarette = 9.4 ± 1.0 ng/ml). Mean peak COHb concentration differed significantly (waterpipe = 4.5% ± 0.3%; cigarette = 1.2% ± 0.1%). Subjective effect changes for waterpipe and cigarette were comparable in magnitude but often longer lived for waterpipe. Conclusions: Relative to a cigarette, waterpipe tobacco smoking was associated with similar peak nicotine exposure, 3.75-fold greater COHb, and 56-fold greater inhaled smoke volume. Waterpipe and cigarette influenced many of the same subjective effect measures. These findings are consistent with the conclusion that waterpipe tobacco smoking presents substantial risk of dependence, disease, and death, and they can be incorporated into prevention interventions that might help deter more adolescents and young adults from experimenting with an almost certainly lethal method of tobacco use. [ABSTRACT FROM AUTHOR]

Introduction:: Although water pipe tobacco smoking is common in Lebanon and Syria, prevalence in neighboring Jordan is uncertain. The purposes of this study were (a) to assess the prevalence of water pipe tobacco smoking among university students in Jordan and (b) to determine associations between sociodemographic variables and water pipe tobacco smoking in this population. [ABSTRACT FROM PUBLISHER]

Introduction:: Potential-reduced exposure products (PREPs) are marketed as a way for smokers to continue using tobacco while possibly lessening their tobacco toxicant intake. Some tobacco-based PREPs are combustible and intended to be smoked, while others are noncombustible and intended to be administered orally (e.g., Camel Snus [CS] tobacco sachets and Ariva tobacco tablets). The ability of these noncombustible PREPs to reduce smokers’ exposure to cigarette-delivered toxicants and suppress tobacco abstinence symptoms effectively is unclear. Clinical laboratory methods have been used to measure combustible PREP-associated toxicant exposure and abstinence symptom suppression and could be applied to evaluating the effects of orally administered noncombustible PREPs. [ABSTRACT FROM PUBLISHER]

Introduction:: Understanding factors that influence tobacco use often involves detailed assessment of smoking behavior (i.e., puff topography) via mouthpiece-based, computerized devices. Research suggests that the use of a mouthpiece to evaluate topography may alter natural smoking behavior. This study was designed to compare topography measurement using mouthpiece-based methods (i.e., desktop and portable computerized devices) to methods that do not use a mouthpiece (i.e., direct observation). [ABSTRACT FROM PUBLISHER]

Introduction:: Waterpipe tobacco smoking is increasing in popularity though the toxicant exposure and effects associated with this tobacco use method are not well understood. [ABSTRACT FROM PUBLISHER]

Several potential reduced exposure products (PREPs) for smokeless tobacco (SLT) users are marketed in the United States, though their effects are largely unknown. These products include some that are low in tobacco-specific nitrosamines (TSNs), like Stonewall, a pressed tobacco tablet, and General snus, a moist snuff product produced in Sweden. Methodology assessing the toxicant exposure and effects of cigarette-like PREPs for smokers has been developed, and might be modified for use in evaluating PREPs for SLT users. This report describes two studies examining the toxicant exposure and effects of two PREPs for SLT users. Study 1 (n = 13) consisted of four 4.5-hr laboratory sessions where SLT products (own brand, Stonewall, General snus, and tobacco-free placebo) were used for four 30-min episodes and nicotine exposure and tobacco/nicotine abstinence symptoms were measured. Study 2 (n = 19) consisted of four 5-day ad libitum use periods when participants used own brand, Stonewall, General snus, or no SLT and urinary levels of metabolites of nicotine (cotinine) and the TSN 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNAL) and abstinence symptoms were measured. Compared with own brand, Stonewall was associated with lower levels of cotinine and NNAL, while General snus was associated with similar levels of cotinine and lower levels of NNAL. Abstinence symptoms generally did not differ across tobacco conditions. These results show that clinical laboratory methods can be used to evaluate the toxicant exposure and abstinence symptom suppression associated with PREPs for SLT users. [ABSTRACT FROM AUTHOR]

Although waterpipe tobacco smoking seems to be increasing on U.S. university campuses, these data have come from convenience samples. We aimed to determine the prevalence of and associations with waterpipe tobacco smoking among a random sample of students. We surveyed a random sample of graduate and undergraduate students at a large, urban university. We used multivariate modeling to determine independent associations between belief-related predictors and waterpipe tobacco smoking. Of the 647 respondents, waterpipe smoking was reported in 40.5%, over the past year in 30.6%, and over the past 30 days in 9.5%. Over half of the sample (52.1%) perceived that tobacco smoking from a waterpipe was less addictive than cigarette smoking. In fully adjusted multivariate models, 1-year waterpipe smoking was associated with low perceived harm (OR = 2.54, 95% CI = 1.68, 3.83), low perceived addictiveness (OR = 4.64, 95% CI = 3.03, 7.10), perception of high social acceptability (OR = 20.00, 95% CI = 6.03, 66.30), and high perception of popularity (OR = 4.72, 95% CI = 2.85, 7.82). In this sample, lifetime waterpipe use was as common as lifetime cigarette use. Perception of harm, perception of addictiveness, social acceptability, and popularity were all strongly related to waterpipe smoking. [ABSTRACT FROM AUTHOR]

Waterpipe tobacco smoking is increasingly common worldwide, and evidence about its harmful effects to smokers is emerging. However, no studies have investigated the potential exposure of nonsmokers to waterpipe smoke. We measured particulate matter (PM) emissions (PM2.5, PM10) before and during laboratory sessions in which 20 individuals used a waterpipe to smoke tobacco and 20 individuals smoked a cigarette (10 for each particle-size/smoking-method), as well as 10 waterpipe and 10 cigarette smoldering sessions (i.e., without a smoker). A TSI-SidePak aerosol monitor obtained PM2.5, PM10 background, smoking, and maximum levels. Mean PM2.5 rose 447% for waterpipe (from 48 µg/m3 background to 264 µg/m3 smoking), and by 501% for cigarettes (from 44 µg/m3 to 267 µg/m3), whereas mean PM10 rose by 563% for waterpipe (from 55 µg/m3 to 365 µg/m3), and by 447% for cigarettes (from 52 µg/m3 to 287 µg/m3) (p<.05 for all). The increase in PM during cigarette smoking was due primarily to PM2.5, given that the proportion of PM2.5 from total PM10 increase was 95% compared with 70% for waterpipe (p<.05). Maximum PM2.5 was 908 µg/m3 for waterpipe and 575 µg/m3 for cigarettes, whereas maximum PM10 was 1052 µg/m3 for waterpipe and 653 µg/m3 for cigarettes. Mean PM2.5 and PM10 smoldering levels did not differ from background for waterpipe but were significantly higher for cigarettes (PM2.5: 33-190 µg/m3; PM10: 42-220 µg/m3). Policymakers considering clean air regulations should include waterpipe tobacco smoking, and the public should be warned about this source of smoke exposure. [ABSTRACT FROM AUTHOR]

The tobacco industry markets potential reduced exposure products (PREPs) to smokers, including oral products that are intended to be used in situations where cigarettes cannot. For example, Ariva, marketed by Star Scientific, is a tablet made from compressed tobacco powder and is intended for "adult smokers in situations where they cannot or choose not to smoke." No objective data are available regarding Ariva's effects in smokers, including its nicotine delivery, cardiovascular profile, or subjective effects. In this single-session, clinical laboratory study, 10 overnight-abstinent cigarette smokers were administered one Ariva tablet, followed 90 min later by two Ariva tablets, followed 90 min later by three Ariva tablets. Participants allowed each dose to dissolve in their mouths according to package instructions. Blood was sampled, heart rate monitored, and subjective effects assessed regularly. Ariva delivered nicotine in a dose-dependent manner; mean (SD) nicotine levels increased from 2.4 ng/ml (0.9) at baseline, to 3.4 ng/ml (1.4) 45 min post-1 tablet, 7.3 ng/ml (4.0) 45 min post-2 tablets, and 9.7 ng/ml (4.4) 45 min post-3 tablets. Heart rate increased after tablet administration, independent of dose. The tablets also significantly decreased subjective ratings of craving and urge, and increased ratings of nausea. Based on this short-term laboratory evaluation, Ariva exposes users to nicotine and may suppress some symptoms of tobacco abstinence, though its nausea-inducing characteristics may limit initial acceptability. [ABSTRACT FROM AUTHOR]