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Abstract Background The changing prevalence and patterns of tobacco use, the advent of novel nicotine delivery devices, and the development of new biomarkers prompted an update of the 2002 Society for Research on Nicotine and Tobacco (SRNT) report on whether and how to apply biomarker verification for tobacco use and abstinence. Methods The SRNT Treatment Research Network convened a group of investigators with expertise in tobacco biomarkers to update the recommendations of the 2002 SNRT Biochemical Verification Report. Results Biochemical verification of tobacco use and abstinence increases scientific rigor and is recommended in clinical trials of smoking cessation, when feasible. Sources, appropriate biospecimens, cutpoints, time of detection windows and analytic methods for carbon monoxide, cotinine (including over the counter tests), total nicotine equivalents, minor tobacco alkaloids, and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol are reviewed, as well as biochemical approaches to distinguishing cigarette smoking from use of electronic nicotine delivery devices (ENDS). Conclusions Recommendations are provided for whether and how to use biochemical verification of tobacco use and abstinence. Guidelines are provided on which biomarkers to use, which biospecimens to use, optimal cutpoints, time windows to detection, and methodology for biochemical verifications. Use of combinations of biomarkers is recommended for assessment of ENDS use. Implications Biochemical verification increases scientific rigor, but there are drawbacks that need to be assessed to determine whether the benefits of biochemical verification outweigh the costs, including the cost of the assays, the feasibility of sample collection, the ability to draw clear conclusions based on the duration of abstinence, and the variability of the assay within the study population. This paper provides updated recommendations from the 2002 SRNT report on whether and how to use biochemical markers in determining tobacco use and abstinence.

The capability of electronic cigarette devices (e-cigs) to deliver nicotine is key to their potential to replace combustible cigarettes. We compared nicotine delivery and subjective effects associated with the use of two classes of e-cigarettes and cigarettes. 14 e-cigarette users were instructed to vape their own e-cigarette device every 20 seconds for 10 minutes while blood was drawn at 1, 2, 4, 6, 8, 10,12, and 15 minutes after initiating vaping. Users rated withdrawal symptoms and side effects before and after vaping. E-cigarette devices were classified as first-generation (same size as cigarette, no activation button) or advanced (larger than cigarette with an activation button). Separately, 10 cigarette smokers completed a similar protocol. Fisher's Exact Test and two-sided t-tests were used as appropriate to determine differences in outcomes between first-generation e-cigarette users, advanced e-cigarette users, and smokers. Compared to first-generation devices, advanced devices were associated with greater serum nicotine Cmax (ng/ml) (11.5 v. 2.8, p = 0.0231) and greater nicotine boost (ng/ml) (10.8 v. 1.8, p = 0.0177). Overall, e-cigarettes users experienced a significant reduction in withdrawal and craving, although there were no significant differences between users of first-generation and advanced devices. Comparing e-cigarettes overall to cigarettes, cigarettes were associated with greater Cmax (25.9 v. 9.0, p = 0.0043) and greater nicotine boost (21.0 v. 8.2, p = 0.0128). Advanced e-cigarettes delivered significantly more nicotine than first-generation devices but less than combustible cigarettes. Overall, e-cigarette use was associated with a reduction in withdrawal and craving with no reported side effects. The wide variation in nicotine absorption from different e-cigarette devices should be considered in studies of e-cigarettes for smoking cessation.

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.

The coronavirus disease (COVID-19) pandemic has spread in the US with more than 100 million human infections and a million deaths since March 2020. A population of concern are high-risk individuals such as adults who are tobacco users, since COVID-19 is a respiratory disease that affects the lungs. Although 79% of the US population ≥ 18 years of age have completed the primary COVID-19 vaccine series; it is imperative to understand the factors associated with receiving or declining the COVID-19 vaccine among high-risk populations to improve vaccination rates. Guided by the diffusion of innovations (DOI) theory, this study identified factors associated with COVID-19 vaccination and the impact on COVID-19 vaccine uptake in adults who use tobacco. We conducted a cross-sectional study using a sample of Pennsylvanian adult tobacco users by sending a unique survey link to 4,081 email addresses in April 2022. Participants were asked about tobacco use, COVID-19 vaccination status, and reasons for receiving/declining the COVID-19 vaccine. Participants (n = 157) were 75% female, 96% White, 74% current tobacco users, and had a mean age of 50.1 (SD = 10.8) years. Nearly 78% (n = 119) received at least one dose of the COVID-19 vaccine (primary series). We categorized all vaccinated tobacco users into adopter categories of the DOI theory; innovators (10%), early adopters (14%), early majority (33%), late majority (11%), and laggards (32%). The major reason that prompted participants to get the COVID-19 vaccine was to ensure they were well protected against COVID-19 infection (77%). Additionally, the only reason for receiving the vaccine that significantly predicted early vaccine uptake (being an innovator or early adopter) was “to loosen restrictions on mask mandates and social/physical distancing” (p = 0.0180). Among the 22% that did not receive a COVID-19 vaccine, the most common major reason they declined the vaccine was because they felt politics played a big role in the vaccine development process (94%). Our findings suggest that major f actors that influenced why adult tobacco users would receive or decline the COVID-19 vaccine included infection control mandates, protection from the COVID-19 infection, and politics. Investigating these factors can help public health professionals design or develop future vaccination programs for high-risk populations in order to scale up vaccination rates.

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. 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. 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). 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. TRN: NCT01928758, registered August 21, 2013.

ObjectivesTo examine changes in cardiovascular disease (CVD) risk factors, lung function and clinical laboratory markers among people who smoke who used e-cigarettes to reduce their cigarette smoking.DesignFour-arm, parallel-group, double-blind, randomised placebo-controlled trial.SettingTwo sites—Virginia Commonwealth University (Richmond, Virginia, USA) and Penn State University, College of Medicine (Hershey, Pennsylvania, USA).ParticipantsAdults (n=520) aged 21–65 years who smoked at least 10 cigarettes per day, had an expired-air carbon monoxide reading of >9 parts per million at baseline and were interested in reducing their cigarette consumption.InterventionsE-cigarettes with 0, 8 or 36 mg/mL nicotine liquid concentration or a cigarette substitute.Primary outcome measuresCVD risk factors (blood lipids, C-reactive protein, blood pressure, heart rate, waist-to-hip ratio, body mass index and INTERHEART risk score), lung function (spirometry indices, and pulmonary symptoms and functional state using the Clinical Chronic Obstructive Pulmonary Disorder Questionnaire), and other clinical laboratory markers (complete blood count and complete metabolic panel).ResultsAt 6 months, the use of nicotine e-cigarettes caused no significant between-group differences for most measures. However, participants randomised to the 36 mg/mL e-cigarette condition had significantly higher levels of high-density lipoprotein (HDL) (p=0.003 unadjusted, p=0.002 adjusted) and lower levels of low-density lipoprotein (LDL) (p=0.044 adjusted) and cholesterol/HDL ratio (p=0.034 unadjusted, p=0.026 adjusted) compared with the cigarette substitute condition. Also, those in the 36 mg/mL e-cigarette condition had higher HDL levels than those in the 0 mg/mL condition (p=0.016 unadjusted, p=0.019 adjusted).ConclusionsParticipants randomised to the highest nicotine e-cigarette condition showed modest improvements in some measures of blood lipids (eg, increased HDL, and reduced LDL and cholesterol/HDL ratio) as compared with a non-aerosol cigarette substitute among individuals attempting to reduce their cigarette smoking. Future studies of e-cigarettes for smoking cessation would benefit from including these measures to further explore the results found in this study.Trial registration numberNCT02342795.

External examination revealed the following (figure 1). The mechanism is complex obstruction of the maxillary sinus resulting in hypoventilation, a negative pressure and collapse of the orbital floor.1 The onset of symptoms can be sudden and alarming, as in this case, resulting in presentation to the ED.2 It is important, when assessing such patients, to examine and document pupil sizes and reactions, lid positions and eye movements to exclude Horner’s syndrome and III nerve palsy. The diagnosis of silent sinus syndrome is confirmed by CT, which shows opacity of the affected maxillary sinus with downward bowing of the orbital floor as shown on this patient’s scan (figure 2).3 Figure 2.

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.

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.

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.