Nicotine Delivery of a Menthol-Flavored Heat-not-Burn Tobacco Product During Directed Use.

INTRODUCTION: IQOS was authorized by the U.S. Food and Drug Administration (FDA) as a modified-risk tobacco product. We conducted a pharmacokinetic study evaluating the nicotine delivery and subjective effects of IQOS use among current menthol cigarette smokers to better understand if IQOS is an acceptable cigarette alternative in light of the proposed menthol cigarette ban. AIMS AND METHODS: Participants were adult smokers of >4 menthol cigarettes per day. After 14-hour nicotine abstinence, participants were provided an IQOS device and menthol heatstick to puff every 20 seconds for a total of 14 puffs. Blood samples were collected at baseline and during active use to calculate nicotine boost from baseline to peak concentration. Nicotine withdrawal symptoms were collected before and after IQOS use. In addition, a modified Product Evaluation Scale for IQOS was collected after use. RESULTS: Participants (n = 8) were a mean age of 43.9 years, 63% were female, 88% identified as White, and they smoked a mean of 17.1 menthol cigarettes per day. After IQOS use, the mean nicotine boost obtained was 15.96 ng/mL (SD = 6.91) (range 9.31 to 30.55 ng/mL). Most (75%) participants reported enjoying use of the product "a lot" or greater and more than half (62.5%) reported reduced cigarette cravings. Most participants reported no side effects after use; however, two experienced dry mouth, three experienced dizziness, one experienced throat irritation, and one experienced headache. CONCLUSION: We found that directed use (14 puffs) of menthol IQOS delivered a mean nicotine boost of 15.96 ng/mL which reduced craving for a cigarette. The majority of participants enjoyed use of IQOS and reported mild side effects. IMPLICATIONS: Menthol IQOS delivered a sufficient dose of nicotine perceived as satisfying by menthol cigarette smokers and it reduced craving with mild side effects. Menthol IQOS has potential to serve as a less harmful alternative for menthol cigarette smokers. The availability of modified risk products like IQOS should be considered by FDA's Comprehensive Plan for Tobacco and Nicotine Regulation.

Effects of liquid nicotine concentration and flavour on the acceptability of electronic nicotine delivery systems (ENDS) among people who smoke participating in a randomised controlled trial to reduce cigarette consumption.

BACKGROUND: Research is needed to understand the acceptability of electronic nicotine delivery systems (ENDS) as a smoking reduction aid. This study examines the acceptability of ENDS by liquid nicotine concentration and flavour among people who smoke using ENDS to reduce their smoking. METHODS: People who smoke cigarettes but were naïve to ENDS participated in a double-blind randomised controlled trial to reduce conventional cigarette smoking. Participants were randomised to either a control cigarette substitute (CS) or one of three ENDS groups; 0 mg/mL, 8 mg/mL or 36 mg/mL nicotine concentration. ENDS flavour was chosen by the participant (tobacco or menthol). Participants reported their CS, ENDS and cigarettes per day (CPD) from the past 7 days at 1-month, 3-month and 6-month follow-up visits. Participants also reported side effects and measures of satisfaction, psychological reward, aversion and craving relief. Outcome variables were modelled using linear mixed effects by the following groups: liquid nicotine concentration, flavour and a flavour-nicotine concentration interaction. RESULTS: Participants (n=520) were 41.2% male, 67.3% white, had a mean age of 46.2 years and smoked a mean of 18.6 CPD (SD=7.74) at baseline. All flavour and concentration groups decreased CPD from baseline to all follow-up visits with the 36 mg/mL experiencing the greatest reduction, compared with the 0 mg/mL and 8 mg/mL groups. All groups except the 36 mg/mL group decreased their product use over time. The use of menthol flavour was associated with fewer side effects at 3 months (p=0.02) and lesser aversion at 1 month (p=0.03) compared with tobacco-flavoured ENDS. The 36 mg/mL group experienced the greatest craving relief and greatest aversion compared with other groups. CONCLUSIONS: Both nicotine concentration and flavour appear to have independent, as well as interactive, effects that influence ENDS acceptability among people who use cigarettes.

A Comparison of Mental Health Symptoms among Adults Who Vape Nicotine, Cannabis, or Both.

OBJECTIVES: Dual use of combustible cannabis and nicotine is related to worse mental health symptoms (MHS); however, little is known about MHS among those who vape cannabis and nicotine. The current study aimed to determine if dual use of cannabis and nicotine vapes is associated with worse MHS compared to single use and to identify correlates of MHS for dual users. METHODS: We used Amazon Mechanical Turk to survey adults (N = 492) who used nicotine or cannabis vapes in the past 30 days on stress, anxiety, depression, vape use behaviors and sociodemographic information. We conducted hierarchical linear regressions to compare MHS between dual vs. single substance vape use and to identify correlates of MHS, including sociodemographic variables and vape use characteristics. RESULTS: The final sample was 37.6% female, 87.6% White, and 11% Hispanic/Latinx with a mean age of 34.15 years. After controlling for sociodemographic characteristics and combustible product use, dual users had significantly higher mean MHS severity than single users. For dual users, younger age and being married were associated with higher symptoms of depression and stress. Holding a medical cannabis card was associated with higher anxiety symptoms. CONCLUSION: The findings suggest that dual use of cannabis and nicotine vapes is associated with worse MHS severity compared to single substance use.

Effectiveness of smoking cessation interventions among persons with cancer: A systematic review.

OBJECTIVES: Continued smoking after cancer diagnosis is associated with worse outcomes, however, many persons diagnosed with cancer who smoke are unable to quit successfully. Effective interventions are needed to promote quitting in this population. The purpose of this systematic review is to understand the most effective interventions for smoking cessation among persons with cancer and to identify gaps in knowledge and methodology to suggest directions for future research. METHODS: Three electronic databases (The Cochrane Central Register of Controlled trials, MEDLINE, and EMBASE) were searched for studies of smoking cessation interventions among persons with cancer, published up to 1 July 2021. Title and abstract screening, full-text review, and data extraction was completed by two independent reviewers, via Covalence software, with any discordance resolved by a third reviewer. A quality assessment was completed using the Cochrane Risk of Bias Tool Version 2. RESULTS: Thirty-six articles were included in the review, including 17 randomized-controlled trials (RCTs) and 19 non-RCT studies. Of the 36 studies, 28 (77.8%) utilized an intervention that included both counseling and medication, with 24 (85.7%) providing medication to participants at no cost. Abstinence rates in the RCT intervention groups (n = 17) ranged from 5.2% to 75%, while the non-RCTs found abstinence rates ranging from 15% to 46%. Overall, studies met a mean of 2.28 out of seven quality items, ranging from 0 to 6. CONCLUSIONS: Our study highlights the importance of utilizing intensive combined behavioral and pharmacological interventions for persons with cancer. While combined therapy interventions seem to be the most effective, more research is needed, as current studies have several quality issues, including the lack of biochemical verification for abstinence.

Changes in Nicotine Dependence Among Smokers Using Electronic Cigarettes to Reduce Cigarette Smoking in a Randomized Controlled Trial.

INTRODUCTION: How nicotine dependence will be affected when current smokers initiate electronic cigarette (e-cigarette) use to reduce cigarette smoking is unknown. This study evaluated cigarette, e-cigarette, and total nicotine dependence more than 6 months among smokers reducing cigarette consumption by replacing with e-cigarettes. AIMS AND METHODS: Adult cigarette smokers were randomized to one of four conditions (36 mg/ml e-cigarette, 8 mg/ml e-cigarette, 0 mg/ml e-cigarette, or cigarette-substitute [CS] [provided at no cost]) and instructed to reduce their cigarette smoking by 75% at 1 month. Participants completed follow-up at 1, 3, and 6 months. The Penn State Nicotine Dependence Index (PSNDI) measured dependence on cigarettes (PSCDI) and e-cigarettes (PSECDI). Urine cotinine measured total nicotine exposure. Linear mixed effects models for each outcome were conducted and included interaction terms between visit and condition. RESULTS: Participants (n = 520) were 58.8% female, 67.3% White, and 48.0 years old. At baseline, the median number of cigarettes smoked per day was 17.3 and the mean PSCDI score was 13.4, with no significant differences between conditions. Participants in the e-cigarette conditions reported significantly lower PSCDI scores, compared with baseline, and with the CS condition at all follow-up visits. Those in the 36 mg/ml e-cigarette condition reported greater PSECDI scores at 6 months, compared with baseline and the 0 mg/ml and 8 mg/ml conditions. At all follow-up visits, there were no differences in total nicotine exposure compared to baseline, nor between any conditions. CONCLUSIONS: E-cigarette use was associated with reduced cigarette dependence, compared to the CS, without significant increases in total nicotine exposure. IMPLICATIONS: Initiation of electronic cigarette use while continuing to smoke could potentially increase nicotine dependence. In this randomized trial aimed at helping smokers to reduce their cigarette intake, we found that use of an e-cigarette was associated with a reduction in cigarette dependence and an increase in e-cigarette dependence (in the condition with the highest nicotine concentration only), with no long term increase in total nicotine dependence or nicotine exposure.

Effect of Electronic Nicotine Delivery Systems on Cigarette Abstinence in Smokers With No Plans to Quit: Exploratory Analysis of a Randomized Placebo-Controlled Trial.

INTRODUCTION: The extent to which use of electronic nicotine delivery systems (ENDS) for smoking reduction leads to cigarette abstinence in smokers with no plans to quit smoking is unclear. This exploratory analysis examined the effects of ENDS delivering different amounts of nicotine on cigarette abstinence up to 24-week follow-up, in comparison to placebo or a behavioral substitute. METHODS: This four-arm parallel-group, randomized, placebo-controlled trial took place at two academic medical centers in the United States (Penn State Hershey and Virginia Commonwealth University). Participants were current adult smokers (N = 520) interested in reducing but not planning to quit. They received brief advice and were randomized to one of four 24-week conditions, receiving either an eGo-style ENDS paired with 0, 8, or 36 mg/ml nicotine liquid (double-blind) or a cigarette-shaped tube, as a cigarette substitute (CS). Self-reported daily cigarette consumption and exhaled carbon monoxide (CO) were measured at all study visits. Outcomes included intent-to-treat, self-reported 7-day cigarette abstinence, biochemically confirmed by exhaled CO at 24 weeks after randomization. RESULTS: At 24 weeks, significantly more participants in the 36 mg/ml condition (14/130, 10.8%) than in the 0 mg/ml condition (1/130, 0.8%) and the CS condition (4/130, 3.1%) were abstinent (relative risk = 14 [95% CI = 1.9-104.9] and 3.5 [95% CI = 1.2-10.4], respectively). The abstinence rate in the 8 mg/ml condition was 4.6% (6/130). CONCLUSIONS: When smokers seeking to reduce smoking tried ENDS, few quit smoking in the short term. However, if smokers continued to use an ENDS with cigarette-like nicotine delivery, a greater proportion completely switched to ENDS, as compared with placebo or a cigarette substitute. IMPLICATIONS: The extent to which use of electronic nicotine delivery systems (ENDS) for smoking reduction leads to cigarette abstinence in smokers with no plans to quit smoking was unclear. This randomized trial found that ENDS with nicotine delivery approaching that of a cigarette are more effective in helping ambivalent smokers to quit cigarette smoking.

Intentions and Attempts to Quit JUUL E-Cigarette Use: The Role of Perceived Harm and Addiction.

INTRODUCTION: Research on electronic cigarette (e-cigarette) quit intentions and attempts is limited despite the potential health benefits of quitting, especially for long-term users. The current study aimed to investigate perceptions of harm and addictiveness and tobacco use characteristics associated with quit variables among users of a popular e-cigarette brand, JUUL. METHODS: We surveyed 301 US adult JUUL users on their tobacco use characteristics, perceptions of JUUL harm and addictiveness, and quit variables at 3 time points, from July 2019 to April 2020. We used logistic regression models to assess demographic characteristics, smoking characteristics, and perceptions of JUUL harm and addictiveness as correlates of e-cigarette quit intentions, attempts, importance, and confidence. RESULTS: Twenty-three percent of the sample had intentions to quit using JUUL within the year, and 22.6% reported making a lifetime quit attempt. The average rating of quit importance was 4.1 and quit confidence was 5.8 on a Likert scale of 1 to 10. More than 90% of the sample indicated that JUUL was at least moderately addictive, whereas less than one-quarter indicated that JUUL was as harmful or more harmful than smoking. Higher levels of perceived JUUL addictiveness were associated with more quit intentions, attempts, and importance. Higher levels of perceived JUUL harm compared with smoking were associated with more quit importance. CONCLUSION: Our findings suggest that a small proportion of adult JUUL users are interested in quitting. Self-reported perceptions of JUUL's addiction potential may be related to more quit attempts. Findings highlight the need for evidence-based information on e-cigarette addictiveness and effective strategies for cessation.

Dependence and Use Characteristics of Adult JUUL Electronic Cigarette Users.

BACKGROUND: JUUL is a popular electronic cigarette (e-cig) that is capable of delivering nicotine similarly to a cigarette. While known to deliver high doses of nicotine, there is little systematic evidence to show how the nicotine delivery of JUUL translates to user dependence. Purpose: The purpose of the study was to evaluate self-reported dependence of JUUL users and examine the relationship of dependence to user behaviors. Methods: Current JUUL users were recruited via Amazon Mechanical Turk to complete an online survey about their use of JUUL. Participants were asked to complete the Penn State Electronic Cigarette Dependence Index (PSECDI) and to answer questions about their use patterns and other tobacco use. Means and frequencies were used to describe the sample. A linear regression model was used to predict user dependence. Results: Participants (n = 76) were 65.4% male with a mean age of 31.9 (SD = 8.3) years. The mean PSECDI score was 7.8 (SD = 4.2) and ranged from no (15.8%) to high (14.5%) dependence. Overall predictors of a greater PSECDI score included reporting ever stealth vaping (ß = 2.8, p < .01) and reporting greater use days in the past 30 (ß = 3.5, p < .01). Conclusions: On average, JUUL users reported low to medium nicotine dependence on the PSECDI. JUUL user dependence may be more similar to e-cig user dependence than cigarette smoker dependence. These preliminary findings should be followed up in studies of larger samples of Juul users, collecting multiple measures of dependence, as well as biomarkers of nicotine intake (e.g. cotinine).

Acceptability of electronic nicotine delivery systems (ENDS) among HIV positive smokers.

Electronic nicotine delivery systems (ENDS) have the potential to help smokers living with HIV/AIDS (PLWHA) to reduce harms from tobacco use. However, little is known about ENDS use among PLWHA. This study's aim was to evaluate the acceptability of two types of ENDS among PLWHA not planning to quit smoking. The study utilized a cross-over design where participants used two ENDS in a random order as smoking substitutes during two use periods separated by 7 days. Exhaled carbon monoxide (CO) was analyzed and participants reported daily cigarette and ENDS use and completed ratings on ENDS acceptability. Participants (n = 17) were a mean age of 49.1 years (SD = 8.8), were 53% white, and 59% male. All participants had controlled HIV disease status. Participants smoked a mean of 16.9 (SD = 7.9) CPD at baseline. Overall, CPD significantly decreased during both ENDS use periods (p < .01) but there were no differences in reduction between the different devices. CO decreased from baseline to follow-up only during the button-activated ENDS use period (p = .03), but there were no differences between ENDS devices. There were no significant differences in ratings of acceptability between ENDS devices. These results suggest that ENDS could be a harm reduction tool for smokers with HIV.

Measurement of Electronic Cigarette Frequency of Use Among Smokers Participating in a Randomized Controlled Trial.

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.

Characteristics of Adult Cigarette Smokers Who "Relight" and the Effects of Exposure to Tobacco Smoke Constituents.

INTRODUCTION: About half of smokers relight their cigarette, a habit that is a risk factor for chronic bronchitis and possibly lung cancer. Little is known about the characteristics of smokers who relight and their dependence on nicotine. It is unknown whether relighting affects exposure to tobacco smoke constituents. This study examined the characteristics of relighters of usual brand cigarettes and whether relighting affects exposure to selected tobacco smoke constituents. METHODS: We explored relighting status and frequency, using baseline data from 248 adult smokers participating in studies of reduced nicotine cigarettes in relation to demographic and cigarette characteristics, smoking behaviors, nicotine dependence, biomarkers of exposure (exhaled carbon monoxide, blood cotinine), and biomarkers of oxidative stress (ratio of oxidized/reduced glutathione). RESULTS: 69.4% (n = 172) of subjects reported relighting, and they relit an average of five cigarettes out of 20. Both relighters and non-relighters smoked a mean of 20 cigarettes per day (p = .6). Relighting was significantly associated with higher nicotine dependence, use of longer rod cigarettes, older age, lower income, and unemployment. There were no significant associations between relighting and blood cotinine, exhaled carbon monoxide or measures of oxidized/reduced blood glutathione. CONCLUSIONS: The majority of subjects were relighters, who had higher levels of nicotine dependence than non-relighters. Relighters had similar levels of plasma cotinine and exhaled carbon monoxide to non-relighters. IMPLICATIONS: No study has compared the cigarette characteristics and biomarkers of exposure of adult cigarette smokers who relight with those who do not. Relighting behavior was common in our sample and was associated with low income, not currently working, higher nicotine dependence, cigarette rod length, daily cigarette use years, and a lifetime history of depressed mood.

E-cigarette users commonly stealth vape in places where e-cigarette use is prohibited.

INTRODUCTION: 'Stealth vaping' is the practice of vaping discreetly in places where electronic cigarette (e-cigarette) use is prohibited. While anecdotal evidence suggests that stealth vaping is common, there have been no formal studies of the behaviour. The purpose of this study is to examine stealth vaping behaviour among experienced e-cigarette users. METHODS: Data were collected from the follow-up survey of a large longitudinal cohort study of adult experienced e-cigarette users conducted in January 2017. To measure stealth vaping behaviour, participants were asked 'Have you ever 'stealth vaped', that is to say, used an e-cig in a public place where it was not approved and attempted to conceal your e-cig use? (yes/no)'. Participants indicating yes completed additional questions about the frequency of stealth vaping and were asked to select all the locations where they commonly stealth vape. Frequencies were used to examine the overall prevalence, frequency and common locations for stealth vaping. A logistic regression model was run to predict stealth vaping. RESULTS: Approximately two-thirds (64.3%, n=297/462) of the sample reported ever stealth vaping, of which 52.5% (n=156/297) reported stealth vaping in the past week. Among stealth vapers (n=297), 31% reported owning a smaller device solely for stealth vaping. The most common places to stealth vape included at work (46.8%), followed by bars/nightclubs (42.1%), restaurants (37.7%), at the movies (35.4%) and in airports/on airplanes (11.7%). Predictors of stealth vaping were greater dependence and owning a smaller device solely for stealth vaping. CONCLUSIONS: Stealth vaping is a common behaviour for many experienced e-cigarette users. More research is needed to understand the reasons for stealth vaping and its potential health and safety implications. This information could help researchers and regulators to design interventions to minimise the public health impact of stealth vaping.

Pilot Randomized Trial of an Automated Smoking Cessation Intervention via Mobile Phone Text Messages as an Adjunct to Varenicline in Primary Care.

OBJECTIVE: Varenicline is a safe and effective aid to smoking cessation but most trials have involved frequent visits or intensive behavioral support unlike that typically provided in primary care. The current study examined if motivational text messages, sent via cellphone, would increase quit rates in smokers being treated with varenicline and 3 brief sessions in a family practice setting. METHODS: This study was a randomized controlled, parallel-group smoking cessation trial. Intervention group participants (n = 74) received daily motivational text messages, additional texted tips in response to keywords, and weekly study questions while control group participants (n = 76) received only weekly study questions. Both groups received individualized counseling. Self-reported non-smoking and exhaled breath CO <10ppm were used to validate smoking abstinence at 3 weeks and 12 weeks. RESULTS: Overall, 30.7% (46/150) of participants were abstinent at the 12 week follow-up and the abstinence rate did not differ between groups (INT 31.1% v. CON 30.3%, p = .91). The only predictor of abstinence at 12 weeks was use of varenicline during a previous quit attempt (p = .01). Intervention group participants were more likely to rate the text messaging program as good or excellent (p < .01), to recommend a similar program to family or friends (p < .01), and to complete positive smoking cessation activities (p = .04), when compared with the control group. CONCLUSION: Although there were no differences in quit rates between the intervention and control group, intervention group participants rated the text messaging system more favorably, were more likely to recommend the program to others, and were more likely to complete positive smoking cessation activities.

Tobacco Use Among Middle and High School Students in Pennsylvania.

We analyzed data from the 2014-2015 Pennsylvania Youth Tobacco Survey to determine prevalence of tobacco use among middle and high school students. For the first time, questions on current (past 30-day) use of electronic cigarettes (e-cigarettes) were included in the survey. For current use, e-cigarettes were the most commonly used tobacco product among middle school students (2.3%; 95% confidence interval [CI], 1.4%-3.2%), and cigarettes were the most commonly used tobacco product among high school students (11.0%; 95% CI, 8.1%-13.8%). Given the changing landscape of tobacco products, collection of comprehensive data on tobacco use, including frequency, is important for monitoring behaviors among adolescents.

A Method for Classifying User-Reported Electronic Cigarette Liquid Flavors.

BACKGROUND: Along with the growth in popularity of electronic cigarette devices (e-cigs), the variety of e-cig liquids (e-liquid) available to users has also grown. Although some studies have published data about the use of flavored e-liquid, there is no standardized way to group flavors, making it difficult to interpret the data and replicate results across studies. The current study describes a method to classify user-reported e-liquid flavors and presents the resulting proportion of users in each flavor group in a large online survey of e-cig users. METHODS: Three thousand seven hundred sixteen participants completed an online survey about their e-cig use and responded to the following open-ended question regarding their use of e-liquid, "What is your favorite flavor and what brand of flavored liquid do you prefer?" Researchers used a 3 step method to determine the flavor attributes present in the e-liquids reported using an online search engine. Once all flavor attributes were identified, researchers used the constant comparative method to group the flavor attributes and delineate how to classify flavors with mixed components (eg, cinnamon Red Hots as a candy not a spice). RESULTS: The resulting classification scheme and proportions of e-liquids in each category were as follows: Tobacco (23.7%), Menthol/mint (14.8%), Fruit (20.3%), Dessert/sweets (20.7%), Alcohol (2.8%), Nuts/spices (2.0%), Candy (2.1%), Coffee/tea (4.3%), Beverage (3.1%), Unflavored (0.4%), and Don't Know/Other (5.8%). CONCLUSION: To better understand the use of flavored e-liquids, standardized methods to classify the flavors could facilitate data interpretation and comparison across studies. This study proposes a method for classifying the characterizing flavors in e-liquids used most commonly by experienced e-cig users. IMPLICATIONS: Current studies on the use of flavored e-liquid have used unclear methods to collect and report information on the use of flavors. This study adds a proposed method for classifying the flavors in the e-liquids used most commonly by experienced e-cig users. With a clear and explicit method for classifying self-reported flavors, future study results may be more easily compared.

Should electronic cigarette use be covered by clean indoor air laws?

BACKGROUND: Some jurisdictions have passed legislation that bans electronic cigarette (e-cig) use (vaping) in public places similarly to smoking. Many other jurisdictions have not yet determined how to regulate vaping in public places. This study examined the proportion of current e-cig users who find their vaping restricted in public places and further evaluated factors associated with the differences between restricted and unrestricted vapers. METHODS: 3960 experienced exclusive e-cig users completed an online survey from December 2012 to May 2014 about their e-cig use. Restricted vapers were defined as those who reported not being able to vape in places where smoking is typically banned. Unrestricted vapers were defined as those who reported being able vape in places where smoking is typically banned. χ2 and two-sided t-tests were used as appropriate to determine differences between variables of interest. RESULTS: Participants were a mean age of 40.3 years, 72.0% male, 91.8% white and 85.1% were from the USA. 26.1% (n=1034) of users reported restricted vaping, while 73.9% (n=2926) reported unrestricted vaping. Restricted vapers used less frequently (p<0.001) and were less dependent compared with unrestricted vapers (p=0.001). Of the restricted vapers, only 12% (n=124) reported finding it difficult to refrain from vaping in places where they were not supposed to. These users were more dependent (p<0.001) and more likely to experience strong cravings (p<0.001), compared with users who did not find it difficult to refrain from vaping. CONCLUSIONS: This study found that most vapers report unrestricted use of their e-cig. Of the restricted vapers, the majority (88%) do not find it difficult to refrain from vaping in places where they are not supposed to vape.

A two-site, two-arm, 34-week, double-blind, parallel-group, randomized controlled trial of reduced nicotine cigarettes in smokers with mood and/or anxiety disorders: trial design and protocol.

BACKGROUND: The U.S. Food and Drug Administration can set standards for cigarettes that could include reducing their nicotine content. Such a standard should improve public health without causing unintended serious consequences for sub-populations. This study evaluates the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxicant exposure, and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders using a two-site, two-arm, double-blind, parallel group, randomized controlled trial (RCT) in four phases over 34 weeks. METHODS: Adult smokers (N = 200) of 5 or more cigarettes per day will be randomized across two sites (Penn State and Massachusetts General). Participants must have not had a quit attempt in the prior month, nor be planning to quit in the next 6 months, meet criteria for a current or lifetime unipolar mood and/or anxiety disorder based on the structured Mini-International Neuropsychiatric Interview, and must not have an unstable medical or psychiatric condition. After a week of smoking their own cigarettes, participants receive two weeks of Spectrum research cigarettes with usual nicotine content (11.6 mg). After this baseline period, participants will be randomly assigned to continue smoking Spectrum research cigarettes that contain either (a) Usual Nicotine Content (11.6 mg); or (b) Reduced Nicotine Content: the nicotine content per cigarette is progressively reduced from approximately 11.6 mg to 0.2 mg in five steps over 18 weeks. At the end of the randomization phase, participants will be offered the choice to either (a) quit smoking with assistance, (b) continue smoking free research cigarettes, or (c) return to purchasing their own cigarettes, for the final 12 weeks of the study. The primary outcome measure is blood cotinine; key secondary outcomes are: exhaled carbon monoxide, urinary total NNAL- 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and 1-hydroxypyrene, oxidative stress biomarkers including 8-isoprostanes, measures of psychiatric symptoms (e.g., depression, anxiety), smoking behavior and dependence (e.g., cigarette consumption, quit attempts), and health effects (e.g., blood pressure, respiratory symptoms). DISCUSSION: Results from this study will inform FDA on the potential effects of regulating the nicotine content of cigarettes and help determine whether smokers with mood and/or anxiety disorders can safely transition to significantly reduced nicotine content cigarettes. TRIAL REGISTRATION: TRN: NCT01928758 , registered August 21, 2013.

A transdisciplinary model to inform randomized clinical trial methods for electronic cigarette evaluation.

BACKGROUND: This study is a systematic evaluation of a novel tobacco product, electronic cigarettes (ECIGs) using a two-site, four-arm, 6-month, parallel-group randomized controlled trial (RCT) with a follow-up to 9 months. Virginia Commonwealth University is the primary site and Penn State University is the secondary site. This RCT design is important because it is informed by analytical work, clinical laboratory results, and qualitative/quantitative findings regarding the specific ECIG products used. METHODS: Participants (N = 520) will be randomized across sites and must be healthy smokers of >9 cigarettes for at least one year, who have not had a quit attempt in the prior month, are not planning to quit in the next 6 months, and are interested in reducing cigarette intake. Participants will be randomized into one of four 24-week conditions: a cigarette substitute that does not produce an inhalable aerosol; or one of three ECIG conditions that differ by nicotine concentration 0, 8, or 36 mg/ml. Blocked randomization will be accomplished with a 1:1:1:1 ratio of condition assignments at each site. Specific aims are to: characterize ECIG influence on toxicants, biomarkers, health indicators, and disease risk; determine tobacco abstinence symptom and adverse event profile associated with real-world ECIG use; and examine the influence of ECIG use on conventional tobacco product use. Liquid nicotine concentration-related differences on these study outcomes are predicted. Participants and research staff in contact with participants will be blinded to the nicotine concentration in the ECIG conditions. DISCUSSION: Results from this study will inform knowledge concerning ECIG use as well as demonstrate a model that may be applied to other novel tobacco products. The model of using prior empirical testing of ECIG devices should be considered in other RCT evaluations. TRIAL REGISTRATION: TRN: NCT02342795 , registered December 16, 2014.

Views of Experienced Electronic Cigarette Users.

BACKGROUND: Awareness and use of electronic cigarettes (e-cigs) has increased significantly in the last five years, but little is known about the experiences, satisfaction, opinions and preferences of e-cigs users. METHOD: 1177 participants completed an online survey about their electronic cigarette preferences, of which 200 were randomly selected for analysis. The data was analyzed using both qualitative and quantitative methods. RESULTS: Participants found the design, the ability to customize, and the quality of vapor to be the most important characteristics of the device. Participants thought the most positive aspects of e-cig use were help to quit smoking, improved overall health, and reduced cost. The negative aspects associated with use were mainly related to side effects, such as dry mouth. When asked to explain how e-cigs were used differently than cigarettes, participants reported puffing more regularly, but taking fewer puffs per session. CONCLUSIONS: Experienced e-cig users stated that initiating e-cig use helped them to quit or reduce their conventional smoking, which they believe reduced their health risks. In comparison to cigarette smoking, e-cig users reported using their e-cig more times per day, but with fewer puffs at each use time. Users acknowledged that more research is needed to understand the safety and long-term effects of use. They mentioned dry mouth as a common side effect and common problems with reliability of e-cigs. Understanding these views may help health professionals to assess and assist e-cig users, and in the future, may help regulators to improve quality and reduce risks.