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IntroductionAvailable evidence is mixed concerning associations between smoking status and COVID-19 clinical outcomes. Effects of nicotine replacement therapy (NRT) and vaccination status on COVID-19 outcomes in smokers are unknown.MethodsElectronic health record data from 104 590 COVID-19 patients hospitalized February 1, 2020 to September 30, 2021 in 21 U.S. health systems were analyzed to assess associations of smoking status, in-hospital NRT prescription, and vaccination status with in-hospital death and ICU admission.ResultsCurrent (n = 7764) and never smokers (n = 57 454) did not differ on outcomes after adjustment for age, sex, race, ethnicity, insurance, body mass index, and comorbidities. Former (vs never) smokers (n = 33 101) had higher adjusted odds of death (aOR, 1.11; 95% CI, 1.06-1.17) and ICU admission (aOR, 1.07; 95% CI, 1.04-1.11). Among current smokers, NRT prescription was associated with reduced mortality (aOR, 0.64; 95% CI, 0.50-0.82). Vaccination effects were significantly moderated by smoking status; vaccination was more strongly associated with reduced mortality among current (aOR, 0.29; 95% CI, 0.16-0.66) and former smokers (aOR, 0.47; 95% CI, 0.39-0.57) than for never smokers (aOR, 0.67; 95% CI, 0.57, 0.79). Vaccination was associated with reduced ICU admission more strongly among former (aOR, 0.74; 95% CI, 0.66-0.83) than never smokers (aOR, 0.87; 95% CI, 0.79-0.97).ConclusionsFormer but not current smokers hospitalized with COVID-19 are at higher risk for severe outcomes. SARS-CoV-2 vaccination is associated with better hospital outcomes in COVID-19 patients, especially current and former smokers. NRT during COVID-19 hospitalization may reduce mortality for current smokers.ImplicationsPrior findings regarding associations between smoking and severe COVID-19 disease outcomes have been inconsistent. This large cohort study suggests potential beneficial effects of nicotine replacement therapy on COVID-19 outcomes in current smokers and outsized benefits of SARS-CoV-2 vaccination in current and former smokers. Such findings may influence clinical practice and prevention efforts and motivate additional research that explores mechanisms for these effects.

IntroductionIt is uncertain whether e-cigarettes facilitate smoking cessation in the real world. We aimed to understand whether and how transitions among cigarette, e-cigarette, and dual use are associated with sociodemographics, dependence measures, and biomarkers.Aims and methodsWe followed 380 adult daily cigarette users and dual users every 2 months for up to 2 years. We estimated transition rates between noncurrent, cigarette-only, e-cigarette-only, and dual use states using a multistate transition model. We estimated univariable hazard ratios (HR) for demographics, dependence measures for cigarettes and e-cigarettes, biomarkers, spousal or partner behaviors, and other measures.ResultsWe estimated that participants transitioned from cigarette-only to e-cigarette-only through a period of dual use. Dual users ceased smoking (transitioning to e-cigarette-only use) at a greater rate than cigarette-only users did (HR 2.44, 95% CI: 1.49, 4.02). However, of the 60% of dual users estimated to transition to single product use in 1 year, 83% would transition to cigarette-only use and only 17% to e-cigarette-only use. E-cigarette dependence measures were generally associated with reduced e-cigarette cessation rather than enhanced cigarette cessation. E-cigarette users motivated by harm or toxicity reduction or because of restrictions on where or when they could smoke had reduced rates of smoking relapse. Cigarette dependence and spousal smoking were barriers to cigarette cessation for dual users, while using e-cigarettes first in the morning, motivation to quit smoking, and sensory, social, and emotional enjoyment of e-cigarettes (secondary dependence motives) were facilitators of smoking cessation among dual users.ConclusionsTobacco control policy and interventions may be informed by the barriers and facilitators of product transitions.ImplicationsAlthough e-cigarettes have the potential to promote smoking cessation, their real-world impact is uncertain. In this cohort, dual users were more likely to quit smoking than cigarette-only users, but the overall impact was small because most dual users returned to cigarette-only use. Moreover, e-cigarette dependence promoted continued dual use rather than smoking cessation. Yet, high motivation to quit smoking and the sensory, social, and emotional enjoyment of e-cigarettes facilitated smoking cessation in dual users. Better understanding the barriers and facilitators of transitions can help to develop regulations and interventions that lead to more effective use of e-cigarettes for smoking cessation.

BackgroundThere is mixed evidence about the relations of current versus past cancer with severe COVID-19 outcomes and how they vary by patient and cancer characteristics.MethodsElectronic health record data of 104,590 adult hospitalized patients with COVID-19 were obtained from 21 United States health systems from February 2020 through September 2021. In-hospital mortality and ICU admission were predicted from current and past cancer diagnoses. Moderation by patient characteristics, vaccination status, cancer type, and year of the pandemic was examined.Results6.8% of the patients had current (n = 7,141) and 6.5% had past (n = 6,749) cancer diagnoses. Current cancer predicted both severe outcomes but past cancer did not; adjusted odds ratios (aOR) for mortality were 1.58 [95% confidence interval (CI), 1.46-1.70] and 1.04 (95% CI, 0.96-1.13), respectively. Mortality rates decreased over the pandemic but the incremental risk of current cancer persisted, with the increment being larger among younger vs. older patients. Prior COVID-19 vaccination reduced mortality generally and among those with current cancer (aOR, 0.69; 95% CI, 0.53-0.90).ConclusionsCurrent cancer, especially among younger patients, posed a substantially increased risk for death and ICU admission among patients with COVID-19; prior COVID-19 vaccination mitigated the risk associated with current cancer. Past history of cancer was not associated with higher risks for severe COVID-19 outcomes for most cancer types.ImpactThis study clarifies the characteristics that modify the risk associated with cancer on severe COVID-19 outcomes across the first 20 months of the COVID-19 pandemic. See related commentary by Egan et al., p. 3.

Objective: The aim of this study was to examine dependence on combustible and e-cigarettes among users of both products (dual users), which may provide important insights into long-term use patterns. Method: Dual users (smoking daily for 3 months, using e-cigarettes at least once/week for the past month; N = 256; 45% women, 71% White, M age 39.0 years) not interested in quitting either product participated in a longitudinal, 2-year, observational study. At baseline, participants completed measures of combustible and e-cigarette dependence (Fagerström Test of Cigarette Dependence [FTCD], e-FTCD, Wisconsin Inventory of Smoking Dependence Motives [WISDM], e-WISDM, Penn State Cigarette Dependence Index, and Penn State E-Cigarette Dependence Index) and carried a study smartphone for 2 weeks to record cigarette and e-cigarette use events. Results: Most measures of dependence were product specific (e.g., FTCD and e-FTCD were not correlated, r = -0.003) and predicted product-specific outcomes (e.g., long-term use of that product). However, individuals used the two products for some of the same secondary dependence motives (e.g., weight control, cognitive and affective enhancement). These secondary, or instrumental, motives predicted use of both products at 1 year. Which product was used first in the morning was strongly related to product dependence scores and likelihood of continued product use at 1 year. Conclusions: Among dual users of combustible and e-cigarettes, measures of e-cigarette and cigarette dependence tended to be unrelated to one another, but dual users tended to use both products for the same instrumental motives. Which product is used first in the morning may serve as a valuable measure of relative dependence on the two products. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Main objectiveThere is limited information on how patient outcomes have changed during the COVID-19 pandemic. This study characterizes changes in mortality, intubation, and ICU admission rates during the first 20 months of the pandemic.Study design and methodsUniversity of Wisconsin researchers collected and harmonized electronic health record data from 1.1 million COVID-19 patients across 21 United States health systems from February 2020 through September 2021. The analysis comprised data from 104,590 adult hospitalized COVID-19 patients. Inclusion criteria for the analysis were: (1) age 18 years or older; (2) COVID-19 ICD-10 diagnosis during hospitalization and/or a positive COVID-19 PCR test in a 14-day window (+/- 7 days of hospital admission); and (3) health system contact prior to COVID-19 hospitalization. Outcomes assessed were: (1) mortality (primary), (2) endotracheal intubation, and (3) ICU admission.Results and significanceThe 104,590 hospitalized participants had a mean age of 61.7 years and were 50.4% female, 24% Black, and 56.8% White. Overall risk-standardized mortality (adjusted for age, sex, race, ethnicity, body mass index, insurance status and medical comorbidities) declined from 16% of hospitalized COVID-19 patients (95% CI: 16% to 17%) early in the pandemic (February-April 2020) to 9% (CI: 9% to 10%) later (July-September 2021). Among subpopulations, males (vs. females), those on Medicare (vs. those on commercial insurance), the severely obese (vs. normal weight), and those aged 60 and older (vs. younger individuals) had especially high mortality rates both early and late in the pandemic. ICU admission and intubation rates also declined across these 20 months.ConclusionsMortality, intubation, and ICU admission rates improved markedly over the first 20 months of the pandemic among adult hospitalized COVID-19 patients although gains varied by subpopulation. These data provide important information on the course of COVID-19 and identify hospitalized patient groups at heightened risk for negative outcomes.Trial registrationClinicalTrials.gov Identifier: NCT04506528 (https://clinicaltrials.gov/ct2/show/NCT04506528).

BackgroundElectronic cigarettes (e-cigarettes) have drastically changed the nicotine and tobacco product landscape. However, their potential public health impact is still unclear. A reliable and valid measure of e-cigarette dependence would likely advance assessment and prognostication of the public health impact of e-cigarettes. The aim of this research was to examine the internal consistency, structure, and validity of three e-cigarette dependence scales.MethodsAdult dual users (smokers who also vape, N = 256) enrolled in an observational cohort study (45.1% women, 70.7% white). At baseline, participants completed the e-cigarette Fagerström Test of Cigarette Dependence (e-FTCD), the e-cigarette Wisconsin Inventory of Smoking Dependence Motives (e-WISDM), and the Penn State Electronic Cigarette Dependence Index (PS-ECDI). All participants provided a urine sample for cotinine analysis and reported e-cigarette use at 1 year.ResultsThe e-WISDM subscales had the highest internal consistency (α = .81-.96), then the PS-ECDI (α = .74) and e-FTCD (α = .51). A single-factor structure for the e-FTCD and an 11-factor structure for the e-WISDM were supported, but the PS-ECDI did not have a single-factor structure. All three e-cigarette dependence scales were highly correlated with validation criteria including continued e-cigarette use at 1 year, but not with e-liquid nicotine concentration or cotinine.ConclusionsThe e-WISDM and PS-ECDI had stronger internal consistency than did the e-FTCD, despite the e-FTCD's single-factor structure, but all 3 measures appear to be valid measures of e-cigarette dependence as suggested by their significant relations with self-perceived addiction, heavy use, early use after overnight deprivation, and continued use over time.ImplicationsThis research provides empirical support for three e-cigarette dependence measures: the e-FTCD, the PS-ECDI, and the e-WISDM among dual users of e-cigarettes and combustible cigarettes. The PS-ECDI and e-WISDM are more reliable, but all three measures were strongly correlated with key dependence constructs such as heavy use and continued use over time.

BackgroundDual use of combustible and electronic cigarettes (e-cigarettes) is a growing use pattern; more than half of e-cigarette users are dual users. However, little is known regarding the course of dual use; for example, the likelihood of discontinuation of either combustible or e-cigarettes or both.MethodsAdult daily smokers and dual users (daily smokers who also vaped at least once per week) who did not intend to quit use of either product in the next 30 days participated in a longitudinal, observational study (N = 322, 51.2% women, 62.7% white, mean age = 42.27 [SD = 14.05]). At baseline, participants completed demographics and smoking and vaping history assessments. They also reported daily cigarette and e-cigarette use via timeline follow-back assessment and provided a breath sample for carbon monoxide assay at 4-month intervals for 1 year.ResultsOf those who completed the year 1 follow-up, 1.9% baseline smokers and 8.0% dual users achieved biochemically confirmed seven-day point-prevalence abstinence from combustible cigarettes (χ2 = 4.57, p = .03). Of initial dual users, by 1 year 43.9% were smoking only, 48.8% continued dual use, 5.9% were vaping only, and 1.4% abstained from both products. Among baseline smokers, 92.3% continued as exclusive smokers. Baseline dual users who continued e-cigarette use were more likely to be white and report higher baseline e-cigarette dependence.ConclusionsIn this community sample, the majority of dual users transitioned to exclusive smoking. A higher percentage of dual users quit smoking than smokers, but attrition and baseline differences between the groups compromise strong conclusions. Sustained e-cigarette use was related to baseline e-cigarette dependence.ImplicationsThis research suggests that dual use of combustible and e-cigarettes is not a sustained pattern for the majority of dual users, but it is more likely to be a continued pattern if the user is more dependent on e-cigarettes. There was evidence that dual users were more likely to quit smoking than exclusive smokers, but this may be due to factors other than their dual use.

IntroductionThe availability of electronic cigarettes (e-cigarettes) has profoundly changed the tobacco product landscape. In the United States, almost 6 million adults use both combustible and e-cigarettes (ie, dual users). The goal of this study was to understand how smokers and dual users differ in terms of demographics, cigarette dependence, and exposure to carcinogens.MethodsAn observational cohort (smokers, n = 166, ≥5 cigarettes/day for 6 months and no e-cigarette use in 3 months; dual users, n = 256, smoked daily for 3 months and used e-cigarettes at least once/week for the past 3 months) completed baseline assessments of demographics, tobacco use, and dependence. They also provided breath samples for carbon monoxide (CO) assay and urine samples for cotinine, 3-hydroxycotinine, and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) assays.ResultsCompared to smokers, dual users (mean e-cigarette use = 5.5 days/week [SD = 1.9]) were significantly younger and more likely to be white, have more education, report a history of psychiatric co-morbidity, and smoke fewer cigarettes per day. There were no differences in CO, cotinine, or 3-hydroxycotinine levels; however, dual users had significantly lower levels of NNAL than did smokers. Most smokers and dual users had no plans to quit smoking within the next year; 91% of dual users planned to continue using e-cigarettes for at least the next year.ConclusionsIn this community sample, dual users are supplementing their smoking with e-cigarette use. Dual users, versus smokers, smoked fewer cigarettes per day and delayed their first cigarette of the day, but did not differ in quitting intentions.ImplicationsThis comparison of a community sample of established dual users and exclusive smokers addresses key questions of dependence and health risks of dual use in real-world settings. Dual users were more likely to be white, younger, have more than a high school education and have a psychiatric history. Dual users also smoked significantly fewer cigarettes and had lower levels of NNAL (a carcinogen), but they did not differ from exclusive smokers in CO or cotinine levels, suggesting that they supplemented their nicotine intake via e-cigarettes.

There is a need for new, targeted smoking cessation interventions for smokers living with HIV. The Information-Motivation-Behavioral Skills (IMB) model has been applied effectively to HIV-related health behaviors and was used in this qualitative study to elicit factors that could lead to the development of innovative and successful cessation interventions for this population. Twenty individuals who smoked from two clinics providing care to people living with HIV participated in open-ended interviews, responding to questions covering the domains of the IMB model, as applied to smokers living with HIV. Participants were enrolled from a larger survey cohort to recruit into groups based on the impact of HIV diagnosis on smoking as well as attempting to enroll a mix of demographics characteristics. Interviews were recorded, transcribed, coded and thematically analyzed using a grounded theory qualitative approach. Interviews continued until thematic saturation was reached. Major themes included: Presence of knowledge deficits regarding HIV-specific health risks of smoking; use of smoking for emotional regulation, where many reported close contacts who smoke and concern with the effect of cessation on their social networks; Use of smoking cessation aids or a telephone-based wellness intervention were acceptable to most. Providing HIV-specific information in cessation advice is of the utmost importance for clinicians caring for smokers living with HIV, as this theme was noted consistently as a potential motivator to quit. Innovative and effective interventions must account for the social aspect of smoking and address other methods of emotional regulation in this population.

Aim: To compare effects of three post‐relapse interventions on smoking abstinence. Design: Sequential three‐phase multiple assignment randomized trial (SMART). Setting: Eighteen Wisconsin, USA, primary care clinics. Participants: A total of 1154 primary care patients (53.6% women, 81.2% White) interested in quitting smoking enrolled from 2015 to 2019; 582 relapsed and were randomized to relapse recovery treatment. Interventions: In phase 1, patients received cessation counseling and 8 weeks nicotine patch. Those who relapsed and agreed were randomized to a phase 2 relapse recovery group: (1) reduction counseling + nicotine mini‐lozenges + encouragement to quit starting 1 month post‐randomization (preparation); (2) repeated encouragement to quit starting immediately post‐randomization (recycling); or (3) advice to call the tobacco quitline (control). The first two groups could opt into phase 3 new quit treatment [8 weeks nicotine patch + mini‐lozenges plus randomization to two treatment factors (skill training and supportive counseling) in a 2 × 2 design]. Phase 2 and 3 interventions lasted ≤ 15 months. Measurements The study was powered to compare each active phase 2 treatment with the control on the primary outcome: biochemically confirmed 7‐day point‐prevalence abstinence 14 months post initiating phase 2 relapse recovery treatment. Exploratory analyses tested for phase 3 counseling factor effects. Findings Neither skill training nor supportive counseling (each on versus off) increased 14‐month abstinence rates; skills on versus off 9.3% (14/151) versus 5.2% (8/153), P = 0.19; support on versus off 6.6% (10/152) versus 7.9% (12/152), P = 0.73. Phase 2 preparation did not produce higher 14‐month abstinence rates than quitline referral; 3.6% (8/220) versus 2.1% [3/145; risk difference = 1.5%, 95% confidence interval (CI) = −1.8−5.0%, odds ratio (OR) = 1.8, 95% CI = 0.5–6.9]. Recycling, however, produced higher abstinence rates than quitline referral; 6.9% (15/217) versus 2.1% (three of 145; risk difference, 4.8%, 95% CI = 0.7–8.9%, OR = 3.5, 95% CI = 1.0–12.4). Recycling produced greater entry into new quit treatment than preparation: 83.4% (181/217) versus 55.9% (123/220), P < 0.0001. Conclusions: Among people interested in quitting smoking, immediate encouragement post‐relapse to enter a new round of smoking cessation treatment ('recycling') produced higher probability of abstinence than tobacco quitline referral. Recycling produced higher rates of cessation treatment re‐engagement than did preparation/cutting down using more intensive counseling and pharmacotherapy. [ABSTRACT FROM AUTHOR]

NicVAX, a nicotine vaccine (3'AmNic-rEPA), has been clinically evaluated to determine whether higher antibody (Ab) concentrations are associated with higher smoking abstinence rates and whether dosages and frequency of administration are associated with increased Ab response. This randomized, double-blinded, placebo-controlled multicenter clinical trial (N = 301 smokers) tested the results of 200- and 400-µg doses administered four or five times over a period of 6 months, as compared with placebo. 3'AmNic-rEPA recipients with the highest serum antinicotine Ab response (top 30% by area under the curve (AUC)) were significantly more likely than the placebo recipients (24.6% vs. 12.0%, P = 0.024, odds ratio (OR) = 2.69, 95% confidence interval (CI), 1.14-6.37) to attain 8 weeks of continuous abstinence from weeks 19 through 26. The five-injection, 400-µg dose regimen elicited the greatest Ab response and resulted in significantly higher abstinence rates than placebo. This study demonstrates, as proof of concept, that 3'AmNic-rEPA elicits Abs to nicotine and is associated with higher continuous abstinence rates (CAR). Its further development as a treatment for nicotine dependence is therefore justified.

Introduction Cross-sectional surveys found behavioral heterogeneity among dual users of combustible and electronic cigarettes. Yet, prior classification did not reflect dynamic interactions between cigarette and e-cigarette consumption, which may reveal changes in product-specific dependence. The contexts of dual use that could inform intervention were also understudied. Methods This study conducted secondary analysis on 13 waves of data from 227 dual users who participated in a 2-year observational study. The k-means method for joint trajectories of cigarette and e-cigarette consumption was adopted to identify the subtypes of dual users. The time-varying effect model was used to characterize the subtype-specific trajectories of cigarette and e-cigarette dependence. The subtypes were also compared in terms of use contexts. Results The four clusters were identified: light dual users, predominant vapers, heavy dual users, and predominant smokers. Although heavy dual users and predominant smokers both smoked heavily at baseline, by maintaining vaping at the weekly to daily level the heavy dual users were able to considerably reduce cigarette use. Yet, the heavy dual users' drop in cigarette dependence was not as dramatic as their drop in cigarette consumption. Predominant vapers appeared to engage in substitution, as they decreased their smoking and increased their e-cigarette dependence. They were also more likely to live in environments with smoking restrictions and report that their use of e-cigarettes reduced cigarette craving and smoking frequency. Conclusions Environmental constraints can drive substitution behavior and the substitution behavior is able to be sustained if people find the substitute to be effective. Implications This study characterizes subtypes of dual users based on the dynamic interactions between cigarette use and e-cigarette use as well as product-specific trajectories of dependence. The subtypes differ in not only sociodemographic characteristics but also contexts of cigarette and e-cigarette use. Higher motivation to use e-cigarettes to quit smoking and less permissive environment for smoking may promote substitution of cigarettes by e-cigarettes. [ABSTRACT FROM AUTHOR]

Aims: To understand dual users' cigarette and e‐cigarette use patterns, including the contexts in which they vape versus smoke and to understand how environmental and internal contexts and smoking patterns differ between dual users and exclusive smokers. Design Longitudinal observational trial. Setting: Research center in Wisconsin, USA. Participants: Adult dual users (n = 162) and adults who exclusively smoked (n = 143), with no plans to quit smoking or vaping in the next 30 days. Measurements Participants carried smartphones for 2 weeks at baseline to record each use event for the two products and report on the context of their product use. The percentage of mornings where participants vaped first versus smoked were used to compute e‐cigarette dependence. Findings Hierarchical linear regression models with random slopes and intercepts examined the within‐ and between‐subject effects of context on the likelihood of vaping (versus smoking); significant fixed effects were tested for moderation by e‐cigarette dependence. Dual users reported significantly more puffs/cigarette [mean = 13.1, standard deviation (SD) = 10.2] than puffs/vape event (mean = 11.7, SD = 11.5; P = 0.01). E‐cigarette dependence moderated the influence of social cues (t‐ratio = 2.4, P = 0.02) and smoking restrictions (t‐ratio = 3.1, P = 0.003) on the likelihood of vaping versus smoking [odds ratio (OR) = 2.30, P = 0.02]. Context was more related to which product was used in those of low versus higher e‐cigarette dependence. Reports of strong cravings to smoke and positive expectancies for cigarettes were associated with a reduced likelihood of vaping, whereas strong cravings to vape and positive vaping expectancies were related to increased likelihood of vaping. Conclusions: Among dual users of cigarettes and e‐cigarettes with no motivation to quit, vaping appears to be related to internal cues and more highly linked with social contexts and smoking restrictions (i.e. under stronger external stimulus control) among those with low to moderate e‐cigarette dependence compared with high e‐cigarette dependence. These findings illustrate the importance of contextual factors in tobacco product use among dual users with the influence of context being reduced at high levels of e‐cigarette dependence. [ABSTRACT FROM AUTHOR]

A study was conducted to determine the efficiency and safety of varenicline for smoking cessation compared with placebo or sustained release bupropion (bupropion SR). Varenicline was found to be efficacious, safe and well-tolerated cessation pharmacotherapy and its short-term and long-term efficacy exceeded that of both placebo and bupropion SR.

In this article, the authors assessed whether continuously scaled symptom parameters derived from growth models (T. M. Piasecki et al., 2003) are linked to smoking at long-term follow-up by using data from a large-scale clinical trial (N = 893). Results revealed that higher withdrawal intercepts, positive linear slopes, and greater volatility were all positively associated with relapse, and cigarette coefficients (indicating smoking-induced withdrawal reduction) were negatively related to relapse. In models keyed around the first lapse to smoking, those destined to lapse reported more severe withdrawal during abstinence, and withdrawal patterns discriminated groups defined according to lapse duration. The findings complement earlier heterogeneity studies in implicating the pattern of changing withdrawal symptoms over time as a factor strongly associated with smoking relapse.