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.

The effects of reduced nicotine content cigarettes on biomarkers of nicotine and toxicant exposure, smoking behavior and psychiatric symptoms in smokers with mood or anxiety disorders: A double-blind randomized trial.

BACKGROUND: The U.S. Food and Drug Administration and the government of New Zealand have proposed a reduction of the nicotine content in cigarettes to very low levels. This study examined the potential effects of this regulation in smokers with affective disorders. METHODS: In a randomized controlled parallel group trial conducted at two sites in the USA (Penn State University, Hershey, PA and Massachusetts General Hospital, Boston, MA) 188 adult smokers with a current (n = 118) or lifetime (n = 70) anxiety or unipolar mood disorder, not planning to quit in the next 6 months, were randomly assigned (1:1) to smoke either Usual Nicotine Content (UNC) (11.6 mg nicotine/cigarette) research cigarettes, or Reduced Nicotine Content (RNC) research cigarettes where the nicotine content per cigarette was progressively reduced to 0.2 mg in five steps over 18 weeks. Participants were then offered the choice to either receive assistance to quit smoking, receive free research cigarettes, or resume using their own cigarette brand during a 12-week follow-up period. Main outcomes were biomarkers of nicotine and toxicant exposure, smoking behavior and dependence and severity of psychiatric symptoms. The pre-registered primary outcome was plasma cotinine. RESULTS: A total of 143 (76.1%) randomized participants completed the randomized phase of the trial, 69 (73.4%) in the RNC group and 74 (78.8%) in the UNC group. After switching to the lowest nicotine content cigarettes, compared to smokers in the UNC group, at the last randomized visit the RNC group had significantly lower plasma cotinine (metabolite of nicotine): difference between groups, -175.7, 95% CI [-218.3, -133.1] ng/ml. Urine NNAL (metabolite of NNK, a lung carcinogen), exhaled carbon-monoxide, cigarette consumption, and cigarette dependence were also significantly lower in the RNC group than the UNC group. No between-group differences were found on a range of other biomarkers (e.g. 8-isoprostanes) or health indicators (e.g. blood pressure), or on 5 different psychiatric questionnaires, including the Kessler K6 measure of psychological distress. At the end of the subsequent 12-week treatment choice phase, those randomized to the RNC group were more likely to have quit smoking, based on initial intent-to-treat sample, n = 188 (18.1% RNC v 4.3% UNC, p = 0.004). CONCLUSION: Reducing nicotine content in cigarettes to very low levels reduces some toxicant exposures and cigarette addiction and increases smoking cessation in smokers with mood and/or anxiety disorders, without worsening mental health. TRIAL REGISTRATION: TRN: NCT01928758, registered August 21, 2013.

A Comparison of Vaping Behavior, Perceptions, and Dependence among Individuals Who Vape Nicotine, Cannabis, or Both.

Background: Electronic delivery systems (e.g., vapes, e-cigarettes) are now popular modes of cannabis and nicotine administration that are often used by the same individuals; however, we still know little about dual nicotine and cannabis vaping. Materials & Methods: An online convenience sample of adult nicotine and/or cannabis vape users residing in the United States completed a 60 min survey on sociodemographic characteristics, cannabis and/or nicotine vape use behaviors and dependence, reasons for vape use, and perceptions of benefits and harms. After data cleaning, we compared dual vs. nicotine-only and cannabis-only vape users with univariate statistics and step-wise hierarchical linear regression analyses. Additionally, we assessed the factor structure, internal consistency, and criterion and convergent validity of the Penn State Cannabis Vaping Dependence Index (PSCVDI). Results: The final sample included 357 dual, 40 cannabis, and 106 nicotine vape users. Compared to nicotine- and cannabis-only vapers, dual vapers started using their nicotine and cannabis vapes at a younger age (p < 0.001), used them for more years (p < 0.001), and were less likely to use their nicotine vape to replace combustible cigarettes (p = 0.047). Dual users vs. single-substance users did not have significantly higher nicotine or cannabis vape dependence scores after controlling for sociodemographic and use behaviors. The PSCVDI showed adequate validity for measuring cannabis vape dependence. Conclusions: This survey is the first to highlight important differences in vape use behaviors and reasons for use between dual vs. cannabis- and nicotine-only vape users.

Pilot randomized controlled trial evaluating the effect of random nicotine delivery on cigarettes per day and smoke exposure.

BACKGROUND: Many smokers report attempting to quit each year, yet most relapse, in part due to exposure to smoking-related cues. It is hypothesized that extinction of the cue-drug association could be facilitated through random nicotine delivery (RND), thus making it easier for smokers to quit. The current study aimed to evaluate the effects of RND on smoking cessation-related outcomes including cigarettes per day (CPD) and exhaled carbon monoxide (CO). METHODS: Participants were current smokers (>9 CPD) interested in quitting. Novel trans-mucosal, orally dissolving nicotine films, developed by Bionex Pharmaceuticals, were used in the study. The pharmacokinetic profile of these films was assessed in single (Experiment 1) and multiple-dose (Experiment 2) administrations prior to the smoking cessation study (Experiment 3). In Experiment 3, participants were randomized 1:1:1 to recieve 4 nicotine films per day of either: placebo delivery (0 mg), steady-state delivery (2 mg), or random nicotine delivery (RND) (0 mg or 4 mg). After two weeks, participants were advised to quit (target quit date, TQD) and were followed up 4 weeks later to collect CPD and CO and to measure dependence (Penn State Cigarette Dependence Index; PSCDI) and craving (Questionnaire of Smoking Urges; QSU-Brief). Means and frequencies were used to describe the data and repeated measures ANOVA was used to determine differences between groups. RESULTS: The pharmacokinetic studies (Experiment 1 and 2) demonstrated that the films designed for this study delivered nicotine as expected, with the 4 mg film delivering a nicotine boost of approximately 12.4 ng/mL across both the single and the multiple dose administration studies. The films reduced craving for a cigarette and were well-tolerated, overall, and caused no changes in blood pressure or heart rate. Using these films in the cessation study (Experiment 3) (n = 45), there was a significant overall reduction in cigarettes smoked per day (CPD) and in exhaled CO, with no significant differences across groups (placebo, steady-state, RND). In addition, there were no group differences in dependence or craving. Adverse events included heartburn, hiccups, nausea, and to a lesser extent, vomiting and anxiety and there were no differences across groups. CONCLUSION: Overall, this pilot study found that RND via orally dissolving films was feasible and well tolerated by participants. However, RND participants did not experience a greater reduction in self-reported CPD and exhaled CO, compared with participants in the steady-state and placebo delivery groups. Future studies to evaluate optimal RND parameters with larger sample sizes are needed to fully understand the effect of RND on smoking cessation-related outcomes.

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.

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.

Characterizing nicotine exposure among a community sample of non-daily smokers in the United States.

BACKGROUND: Over one-quarter of all smokers in the United States identify as non-daily smokers and this number is projected to rise. Unlike daily smokers who typically maintain consistent levels of nicotine exposure with regular smoking, non-daily smokers have variable patterns of smoking that likely result in high intraindividual variability in nicotine intake. The current study aimed to characterize the weekly intraindividual variability in cotinine and identify smoking-related predictors in nondaily smokers. METHODS: An ecological momentary assessment of 60 non-daily smokers ages 24-57 years was conducted over a consecutive 7-day at-home protocol to log each smoking session, assessments of mood and social activity during smoking, and collection of daily saliva samples in a convenience sample from Pennsylvania, USA. Hierarchical linear regression analyses were conducted to determine the effects of smoking characteristics on total cotinine exposure measured by pharmacokinetic area under the curve and the range, maximum, and minimum cotinine values during the week controlling for demographic variables. RESULTS: The mean daily cotinine level was 119.2 ng/ml (SD = 168.9) with individual values that ranged from nondetectable to 949.6 ng/ml. Menthol predicted increased total cotinine levels (P < 0.05). Shorter time to the first cigarette of the day predicted significantly higher minimum (P < 0.05), maximum (P < 0.05), and total cotinine values (P < 0.05) after controlling for covariates. Negative emotions and social interactions with others were also significantly associated with higher cotinine metrics. There was no significant effect of the nicotine metabolite ratio. CONCLUSIONS: Our findings highlight the variability in nicotine exposure across days among non-daily smokers and point to the role of smoking context in nicotine exposure. The findings suggest the need to develop better assessment methods to determine health and dependence risk and personalized cessation interventions for this heterogeneous and growing group of smokers.

Tobacco Use Changes and Perceived Health Risks among Current Tobacco Users during the COVID-19 Pandemic.

COVID-19 has become a global pandemic, with over 81 million cases worldwide. To assess changes in tobacco use as a result of the pandemic, we surveyed a convenience sample of current tobacco users between April and June 2020. The sample was taken from a tobacco user research registry (n = 3396) from the Penn State College of Medicine in Hershey, Pennsylvania, USA. Participants who responded to the survey and were eligible for this study (n = 291) were 25.6% male, 93% white, and had a mean age of 47.3 (SD = 11.6) years. There were no reports of participants testing positive for COVID-19, but 21.7% reported experiencing symptoms associated with the virus. Most participants (67%) believed that their risk of contracting COVID-19 was the same as non-tobacco users, but 57.7% believed that their risk of serious complications, if infected, was greater compared to non-tobacco users. A total of 28% reported increasing their cigarette use during the pandemic. The most common reasons for increased use were increased stress, more time at home, and boredom while quarantined. Nearly 15% reported decreasing their tobacco use. The most common reasons for reduced use were health concerns and more time around non-smokers (including children). A total of 71 (24.5%) users reported making a quit attempt. Characterizing these pandemic-related changes in tobacco use may be important to understanding the full scope of subsequent health outcomes resulting from the pandemic. Tobacco cessation resources should be tailored to allow for safe, appropriate access for those interested in quitting.

COVID-19 Vaccination Uptake and Hesitancy Among Current Tobacco Users.

Novel mRNA vaccines have been developed and were first distributed to high-risk individuals (including smokers) in the United States starting in December 2020 to combat the coronavirus (COVID-19) pandemic. Over one-half of the U.S. adult population has received at least 1 dose of a COVID-19 vaccine, but many others have reported hesitation about becoming vaccinated. We examined COVID-19 vaccine uptake and hesitancy from a convenience sample of Pennsylvanian adult smokers in April 2021, approximately 3 months after tobacco users were eligible to receive vaccination in the state. Participants (n = 231) were 23.4% male, 90.5% white, and had a mean age of 48.1 (SD = 11.9) years. All participants were current tobacco users, with the majority reporting current cigarette smoking (90.9%) with an average of 16 (SD = 8.1) cigarettes smoked per day. Nearly 60% (n = 137) reported receiving at least 1 dose of the vaccine and of those who did not (n = 94), 84% (n = 79) said they were somewhat or very unlikely to get a vaccine. Those who were unvaccinated were more likely to not consume news about COVID-19 (chi-square P-value < .01) and less likely to believe government news sources as reliable information for COVID-19 (chi-square P-value < .01). Qualitative responses among those who were vaccine hesitant expressed concerns about the lack of research on the vaccine, distrust of the safety of the vaccine, and fears about side effects. Understanding vaccine hesitancy among tobacco users can help develop targeted communication strategies and directly address concerns to promote vaccination among this population who may be at an increased risk of severe complications from COVID-19.

Response to Flavored Cartridge/Pod-Based Product Ban among Adult JUUL Users: "You Get Nicotine However You Can Get It".

In order to curb increasing youth electronic cigarette (e-cig) use, the United States Food and Drug Administration (FDA) banned the sale of flavored cartridge/pod-based products in February 2020. This mixed-methods study aimed to evaluate the impact of the FDA ban on adult JUUL users. The samples of current adult JUUL users were surveyed via Amazon Mechanical Turk at three time-points n = 76 (Sample 1); n = 128 (Sample 2); n = 86 (Sample 3) before and after the FDA flavored/pod ban. The participants were asked to report the JUUL flavored pod used most often and answer questions on purchasing generic pods or refilling (Quantitative). JUUL users were then interviewed in order to explore their perceptions and behaviors related to the FDA ban of flavored cartridge/pod-based products (Qualitative; n = 16). Quantitative data analysis evaluated the differences in variables by time-point. Qualitative data were coded into themes while using the constant comparative method. We found a significant decrease in the use of mint pods (43.4%, 22.7%, 16.3%) (p < 0.01), while there was a significant increase in the use of menthol pods (6.6%, 26.6%, 37.2%) (p < 0.01). Themes that emerged from the qualitative data included switching from mint to menthol pods, refilling pods, and switching to other products that are available in the desired flavors, such as generic pods or disposable e-cigs. Future research is needed in order to evaluate the impact of these behaviors on public health.

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.

Effect of Cigarette Rod Length on Smokers Switching to SPECTRUM Cigarettes.

Objectives: Cigarettes vary in rod length but are generally thought of as a constant unit. In this study, we evaluated whether the rod length of participants' usual brand cigarettes affected their perceptions and smoking habits when switching to SPECTRUMs. Methods: Data were analyzed for 341 participants smoking their own brand cigarettes for one week and after switching to normal nicotine content (11.6 mg) SPECTRUMs for 2 weeks. Changes in perceptions of cigarette attributes and biomarkers of smoke exposure were evaluated using linear mixed models among 3 groups: usual length short (ULS, 72 mm); medium/king (ULM, ~84 mm); and long (ULL ≥ 100 mm). Results: Among the 3 cigarette length groups, only ULL smokers' rated SPECTRUMs significantly less strong, harder to draw, lower in taste, and lower in enjoyment (p < .03) compared to usual brand. Among all groups, satisfaction was significantly lower for SPECTRUMs (p < .02). Cigarettes per day (CPD) increased significantly more for ULL (+4.75 CPD) as compared to ULM (+1.38 CPD) (p < .001). When switching to SPECTRUMs, cotinine-per-cigarette decreased among all groups, and exhaled carbon monoxide increased significantly in ULL and ULM smokers (p < .001). Conclusion: People who smoked long cigarettes had the largest changes in perceptions and use when switching to SPECTRUM research cigarettes.

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.

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.

Acceptability of SPECTRUM Research Cigarettes among Participants in Trials of Reduced Nicotine Content Cigarettes.

OBJECTIVES: SPECTRUM research cigarettes (SPECTRUMs) are being used in trials evaluating the effects of switching to reduced nicotine content (RNC) cigarettes. Because smokers have a high brand affinity, we evaluated if they were willing to switch and continue smoking normal nicotine content (NNC) SPECTRUMs. METHODS: We asked smokers (N = 341) to rate their own brand of cigarettes and NNC SPECTRUMs (after 2 weeks of use) using subjective measures including satisfaction, reward, taste, and craving reduction. We measured plasma cotinine, exhaled carbon monoxide (CO), and cigarettes per day (CPD), and recorded reasons for dropping out. RESULTS: After 2 weeks, 95% of participants chose to continue using SPECTRUMs for an additional 18 weeks. Moreover, 67% said SPECTRUMs were as good as or better than their own brand, and 65% said they would consider purchasing them. Ratings of satisfaction, reward, and craving reduction were 10%-15% lower on SPECTRUMs than on their own brand (p < .01). There were no differences in these ratings between menthol and non-menthol smokers. CONCLUSIONS: Menthol and non-menthol SPECTRUMs are acceptable to smokers. Lower SPECTRUM ratings were likely due to brand switching and did not hinder study retention.

Addressing refugee health through evidence-based policies: a case study.

The cumulative total of persons forced to leave their country for fear of persecution or organized violence reached an unprecedented 24.5 million by the end of 2015. Providing equitable access to appropriate health services for these highly diverse newcomers poses challenges for receiving countries. In this case study, we illustrate the importance of translating epidemiology into policy to address the health needs of refugees by highlighting examples of what works as well as identifying important policy-relevant gaps in knowledge. First, we formed an international working group of epidemiologists and health services researchers to identify available literature on the intersection of epidemiology, policy, and refugee health. Second, we created a synopsis of findings to inform a recommendation for integration of policy and epidemiology to support refugee health in the United States and other high-income receiving countries. Third, we identified eight key areas to guide the involvement of epidemiologists in addressing refugee health concerns. The complexity and uniqueness of refugee health issues, and the need to develop sustainable management information systems, require epidemiologists to expand their repertoire of skills to identify health patterns among arriving refugees, monitor access to appropriately designed health services, address inequities, and communicate with policy makers and multidisciplinary teams.

Correction to Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial.

CORRECTION: The title of the original publication [1] had an error; furthermore there were errors in Fig. 2. The corrected version of the title and of Fig. 2 can be found below in this Erratum.

Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial.

BACKGROUND: The Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration jurisdiction over the regulation of all tobacco products, including their nicotine content. Under this act, a major strategy to reduce harm from cigarette tobacco is lowering the nicotine content without causing unintended adverse consequences. Initial research on reduced nicotine content (RNC) cigarettes has shown that smokers of these cigarettes gradually decrease their smoking frequency and biomarkers of exposure. The effectiveness of this strategy needs to be demonstrated in different populations whose response to RNC cigarettes might be substantially mediated by personal or environmental factors, such as low socioeconomic status (SES) populations. This study aims to evaluate the response to a reduced nicotine intervention in low SES smokers, as defined here as those with less than 16 years of education, by switching smokers from high nicotine commercial cigarettes to RNC cigarettes. METHODS/DESIGN: Adults (N = 280) who have smoked five cigarettes or more per day for the past year, have not made a quit attempt in the prior month, are not planning to quit, and have less than 16 years of education are recruited into a two-arm, double-blinded randomized controlled trial. First, participants smoke their usual brand of cigarettes for 1 week and SPECTRUM research cigarettes containing a usual amount of nicotine for 2 weeks. During the experimental phase, participants are randomized to continue smoking SPECTRUM research cigarettes that contain either (1) usual nicotine content (UNC) (11.6 mg/cigarette) or (2) RNC (11.6 to 0.2 mg/cigarette) over 18 weeks. During the final phase of the study, all participants are offered the choice to quit smoking with nicotine replacement therapy, continue smoking the research cigarettes, or return to their usual brand of cigarettes. The primary outcomes of the study include retention rates and compliance with using only research cigarettes and no use of other nicotine-containing products. Secondary outcomes are tobacco smoke biomarkers, nicotine dependence measures, smoking topography, stress levels, and adverse health consequences. DISCUSSION: Results from this study will provide information on whether low SES smokers can maintain a course of progressive nicotine reduction without increases in incidence of adverse effects. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01928719 . Registered on 21 August 2013.