Divergence in Cigarette Discontinuation Rates by Use of Electronic Nicotine Delivery Systems (ENDS): Longitudinal Findings From the United States PATH Study Waves 1-6.

INTRODUCTION: We compare real-world trends in population-level cigarette discontinuation rates among adults (ages ≥21) who smoked cigarettes, by electronic nicotine delivery systems (ENDS) use. AIMS AND METHODS: U.S nationally representative data from adults in the Population Assessment of Tobacco and Health (PATH) Study (2013/14-2021, Waves 1-6) who smoked cigarettes in the past 30 days (P30D) were analyzed (n = 13 640). The exposure was P30D ENDS use. The outcome was P30D cigarette discontinuation at biennial follow-up. Weighted trend analyses were conducted to test for differences in cigarette discontinuation trends by ENDS use. RESULTS: Between 2013/14 and 2015/16, cigarette discontinuation rates were both 16% for those who used ENDS and for those who did not; between 2018/19 and 2021, rates were ~30% for those who used ENDS and ~20% for those who did not; the time by ENDS use interaction was significant. CONCLUSIONS: The relationship between adults' ENDS use and cigarette discontinuation in the context of an expanded ENDS marketplace, new tobacco regulatory actions, and COVID-19 differs from the relationship in earlier years. IMPLICATIONS: It is important for public health decisions to be informed by research based on the contemporary ENDS marketplace and circumstances.

Cigarette and ENDS dual use longitudinal transitions among adults in the Population Assessment of Tobacco and Health (PATH) Study, Waves 4-5 (2016-2019).

Introduction: The study assessed longitudinal transitions among adult (18 and older) past 30-day daily and non-daily dual users of cigarettes and electronic nicotine delivery systems (ENDS). Methods: Using data from Wave 4 (W4; 2016/17) and Wave 5 (W5; 2018/19) of the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative, longitudinal cohort study of US adults, multivariable regressions were conducted among W4 dual users of cigarettes and ENDS to examine past 30-day cigarette smoking at W5. The study also analyzed changes in frequency of past 30-day smoking and cigarettes smoked per day between W4 and W5, stratified by W4/W5 daily/non-daily ENDS use among W4 daily and non-daily cigarette smokers. Results: Among W4 dual users, those smoking daily and using ENDS non-daily had higher odds of daily cigarette smoking at W5 than daily users of both products (AOR: 2.32, 95 % CI: 1.38-3.90). W4 daily smokers who used ENDS daily at Wave 5 smoked cigarettes on fewer days at Wave 5 than W4 daily smokers who were either daily ENDS users at Wave 4 (B = -4.59; SE = 1.43, p < 0.01) or non-daily ENDS users at Wave 4 (B = -4.55; SE = 1.24, p < 0.001). Among W4 non-daily cigarette smokers, W4 non-daily ENDS users who used daily at W5 smoked cigarettes on fewer days (B = -4.04, SE = 1.82) at W5 than those who were non-daily ENDS users at W4 and W5. Conclusions: Findings highlight the importance of frequency of ENDS use in reducing cigarette smoking and could inform smoking cessation interventions among daily cigarette smokers.

Influence of Half-life and Smoking/Nonsmoking Ratio on Biomarker Consistency between Waves 1 and 2 of the Population Assessment of Tobacco and Health Study.

BACKGROUND: Biomarkers of exposure are tools for understanding the impact of tobacco use on health outcomes if confounders like demographics, use behavior, biological half-life, and other sources of exposure are accounted for in the analysis. METHODS: We performed multiple regression analysis of longitudinal measures of urinary biomarkers of alkaloids, tobacco-specific nitrosamines, polycyclic aromatic hydrocarbons, volatile organic compounds (VOC), and metals to examine the sample-to-sample consistency in Waves 1 and 2 of the Population Assessment of Tobacco and Health (PATH) Study including demographic characteristics and use behavior variables of persons who smoked exclusively. Regression coefficients, within- and between-person variance, and intra-class correlation coefficients (ICC) were compared with biomarker smoking/nonsmoking population mean ratios and biological half-lives. RESULTS: Most biomarkers were similarly associated with sex, age, race/ethnicity, and product use behavior. The biomarkers with larger smoking/nonsmoking population mean ratios had greater regression coefficients related to recency of exposure. For VOC and alkaloid metabolites, longer biological half-life was associated with lower within-person variance. For each chemical class studied, there were biomarkers that demonstrated good ICCs. CONCLUSIONS: For most of the biomarkers of exposure reported in the PATH Study, for people who smoke cigarettes exclusively, associations are similar between urinary biomarkers of exposure and demographic and use behavior covariates. Biomarkers of exposure within-subject consistency is likely associated with nontobacco sources of exposure and biological half-life. IMPACT: Biomarkers measured in the PATH Study provide consistent sample-to-sample measures from which to investigate the association of adverse health outcomes with the characteristics of cigarettes and their use.

Relationship Between Tobacco Product Use and Health-Related Quality of Life Among Individuals With COPD in Waves 1-5 (2013-2019) of the Population Assessment of Tobacco and Health Study.

Introduction: We examined the association between tobacco product use and health-related quality of life (HRQoL) among individuals with chronic obstructive pulmonary disease (COPD) in Waves 1-5 of the Population Assessment of Tobacco and Health (PATH) Study. Methods: Adults ≥40 years with an ever COPD diagnosis were included in cross-sectional (Wave 5) and longitudinal (Waves 1 to 5) analyses. Tobacco use included 13 mutually exclusive categories of past 30-day (P30D) single use and polyuse with P30D exclusive cigarette use and ≥5-year cigarette cessation as reference groups. Multivariable linear regression and generalized estimating equations (GEE) were used to examine the association between tobacco use and HRQoL as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 questionnaire. Results: Of 1670 adults, 79.4% ever used cigarettes; mean (standard error [SE]) pack years was 30.9 (1.1). In cross-sectional analysis, P30D exclusive cigarette use, and e-cigarette/cigarette dual use were associated with worse HRQoL compared to ≥5-year cigarette cessation. Compared to P30D exclusive cigarette use, never tobacco use and ≥5-year cigarette cessation were associated with better HRQoL, while e-cigarette/cigarette dual use had worse HRQoL. Longitudinally (n=686), e-cigarette/cigarette dual use was associated with worsening HRQoL compared to both reference groups. Only never tobacco use was associated with higher HRQoL over time compared to P30D exclusive cigarette use. Conclusions: E-cigarette/cigarette dual use was associated with worse HRQoL compared to ≥5-year cigarette cessation and exclusive cigarette use. Never use and ≥5-year cigarette cessation were the only categories associated with higher HRQoL compared to exclusive cigarette use. Findings highlight the importance of complete smoking cessation for individuals with COPD.

Patterns of Premium and Nonpremium Cigar Use in the United States: Findings from Wave 6 (2021) of the Population Assessment of Tobacco and Health Study.

INTRODUCTION: Understanding the characteristics of premium cigar use patterns is essential for minimizing public health harms. Typically, premium cigars are handmade, larger, more expensive, and without the characterizing flavors that are present in other cigar types: Nonpremium traditional cigars, cigarillos, and filtered cigars. AIMS AND METHODS: Self-reported brand and price data were used from Wave 6 of the Population Assessment of Tobacco and Health (PATH) Study to define and estimate premium versus nonpremium cigar use among U.S. adults, as well as to explore cigar smoking patterns, purchasing behavior, and reasons for use by cigar type. RESULTS: In 2021, 0.9% (95% CI = 0.7-1.0) of adults were premium cigar users, compared to 0.4% of nonpremium traditional cigar users (95% CI = 0.3-0.5), 1.1% of cigarillo users (95% CI = 1.0-1.2), and 0.6% filtered cigar users (95% CI = 0.5-0.7). Premium cigar users were overwhelmingly male (97.7%), and 35.8% were aged ≥55 years. The average premium cigar price/stick was $8.67, $5.50-7.00 more than other cigar types. Compared to other cigar types, significantly fewer premium cigar users had a regular brand with a flavor other than tobacco (~15% vs. 38%-53%). Though flavors remained the top reason for premium cigar use, they were less likely to endorse flavors as a reason for use than other cigar users (~40% vs. 68-74%). Premium cigar users had a lower prevalence (aRR: 0.37, 95% CI = 0.25-0.55) of dual use of cigars and cigarettes. CONCLUSIONS: Although <1% of U.S. adults use premium cigars, their use and purchasing characteristics continue to differ from other cigar types, highlighting the importance of capturing data specific to premium cigar use. IMPLICATIONS: This manuscript extends previous research from the National Academies of Science, Engineering, and Medicine report, "Premium cigars: Patterns of use, marketing, and health effects" by utilizing the most recent PATH Study data (Wave 6) to examine patterns of cigar use, including purchasing behavior and reasons for use, by cigar type (eg, premium traditional cigars, nonpremium traditional cigars, cigarillos, and filtered cigars). The findings support continued research on patterns of premium cigar use, which differ from use patterns of other cigar types.

Changes in Tobacco Dependence and Association With Onset and Progression of Use by Product Type From Waves 1 to 3 of the Population Assessment of Tobacco and Health (PATH) Study.

INTRODUCTION: This study examined trajectories of tobacco dependence (TD) in relationship to changes in tobacco product use, and explored the effects of product-specific adding, switching, or discontinued use on dependence over time. AIMS AND METHODS: Data were analyzed from the first three waves from the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative, longitudinal study of adults and youth in the United States. Data included 9556 wave 1 (2013-2014) adult current established tobacco users aged 18 or older who completed all three interviews and had established use at ≥2 assessments. Mutually exclusive groups included: users of cigarettes only, e-cigarettes only, cigars only, hookah only, any smokeless only, cigarette + e-cigarette dual users, and other multiple product users. A validated 16-item scale assessed TD across product users. RESULTS: People who used e-cigarettes exclusively at wave 1 had small increases in TD through wave 3. Wave 1 multiple product users' TD decreased across waves. TD for all other wave 1 user groups remained about the same. For wave 1 cigarette only smokers, switching to another product was associated with lower levels of TD than smokers whose use stayed the same. Movement to no established use of any tobacco product was consistently associated with lower TD for all product users. CONCLUSIONS: Except for wave 1 e-cigarette only users (who experienced small increases in TD), TD among U.S. tobacco product users was stable over time, with daily users less likely to vary from baseline. IMPLICATIONS: The level of TD among most U.S. tobacco users was stable over the first three waves of the PATH Study and trends in levels of TD were predominantly unrelated to changes in patterns of continued product use. Stable levels of TD suggest a population at persistent risk of health impacts from tobacco. Wave 1 e-cigarette users experienced small increases in levels of TD over time, perhaps due to increases in quantity or frequency of their e-cigarette use or increasing efficiency of nicotine delivery over time.

Validating Wave 1 (2014) Urinary Cotinine and TNE-2 Cut-points for Differentiating Wave 4 (2017) Cigarette Use from Non-use in the United States Using Data from the PATH Study.

BACKGROUND: Sex and racial/ethnic identity-specific cut-points for validating tobacco use using Wave 1 (W1) of the Population Assessment of Tobacco and Health (PATH) Study were published in 2020. The current study establishes predictive validity of the W1 (2014) urinary cotinine and total nicotine equivalents-2 (TNE-2) cut-points on estimating Wave 4 (W4; 2017) tobacco use. METHODS: For exclusive and polytobacco cigarette use, weighted prevalence estimates based on W4 self-report alone and with exceeding the W1 cut-point were calculated to identify the percentage missed without biochemical verification. Sensitivity and specificity of W1 cut-points on W4 self-reported tobacco use status were examined. ROC curves were used to determine the optimal W4 cut-points to distinguish past 30-day users from non-users, and evaluate whether the cut-points significantly differed from W1. RESULTS: Agreement between W4 self-reported use and exceeding the W1 cut-points was high overall and when stratified by demographic subgroups (0.7%-4.4% of use was missed if relying on self-report alone). The predictive validity of using the W1 cut-points to classify exclusive cigarette and polytobacco cigarette use at W4 was high (>90% sensitivity and specificity, except among polytobacco Hispanic smokers). Cut-points derived using W4 data did not significantly differ from the W1-derived cut-points [e.g., W1 exclusive = 40.5 ng/mL cotinine (95% confidence interval, CI: 26.1-62.8), W4 exclusive = 29.9 ng/mL cotinine (95% CI: 13.5-66.4)], among most demographic subgroups. CONCLUSIONS: The W1 cut-points remain valid for biochemical verification of self-reported tobacco use in W4. IMPACT: Findings from can be used in clinical and epidemiologic studies to reduce misclassification of cigarette smoking status.

Indicators of Tobacco Dependence Among Youth: Findings From Wave 1 (2013-2014) of the Population Assessment of Tobacco and Health Study.

BACKGROUND: Prior work established a measure of tobacco dependence (TD) among adults that can be used to compare TD across different tobacco products. We extend this approach to develop a common, cross-product metric for TD among youth. METHODS: One thousand one hundred and forty-eight youth aged 12-17 who used a tobacco product in the past 30 days were identified from 13 651 youth respondents in Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study. FINDINGS: Analyses confirmed a single primary latent construct underlying responses to TD indicators for all mutually exclusive tobacco product user groups. Differential Item Functioning analyses supported the use of 8 of 10 TD indicators for comparisons across groups. With TD levels anchored at 0.0 (standard deviation [SD] = 1.0) among cigarette only (n = 265) use group, mean TD scores were more than a full SD lower for e-cigarette only (n = 150) use group (mean = -1.09; SD = 0.64). Other single product use group (cigar, hookah, pipe, or smokeless; n = 262) on average had lower TD (mean = -0.60; SD = 0.84), and the group with the use of multiple tobacco products (n = 471) experienced similar levels of TD (mean = 0.14; SD = 0.78) as the cigarette only use group. Concurrent validity was established with product use frequency among all user groups. A subset of five TD items comprised a common metric permitting comparisons between youth and adults. CONCLUSION: The PATH Study Youth Wave 1 Interview provided psychometrically valid measures of TD that enable future regulatory investigations of TD across tobacco products and comparisons between youth and adult tobacco product use group. IMPLICATIONS: A measure of tobacco dependence (TD) has been established previously among adults to compare TD across tobacco products. This study established the validity of a similar, cross-product measure of TD among youth. Findings suggest a single latent TD construct underlying this measure, concurrent validity of the scale with product use frequency across different types of tobacco users, and a subset of common items that can be used to compare TD between youth and adults who use tobacco.

Update to the design and methods of the PATH Study, Wave 4 (2016-2017).

The Population Assessment of Tobacco and Health (PATH) Study is a nationally representative study of the US population on tobacco use and its effects on health, with four waves of data collection between 2013 and 2017. Prior work described the methods of the first three waves. In this paper, we describe the methods of Wave 4, during which a replenishment sample was added to the ongoing cohort. We describe the design and estimation methods of the continuing Wave 1 cohort (with four waves of data) and the Wave 4 cohort (the new cohort created at Wave 4). We provide survey quality metrics, including response rates for both cohorts and a panel conditioning analysis, and guidance on understanding the target populations for both cohorts.

Blunt and non-blunt cannabis use associated with cigarette, e-cigarette, and cigar initiation: Findings from the population assessment of tobacco and health (PATH) study.

BACKGROUND: Smoking cannabis using a tobacco-derived cigar shell or wrap, called blunt smoking, exposes individuals to non-trivial amounts of nicotine. The extent smoking blunts impact the risk of initiating other tobacco products is not well understood. We investigated if past-year blunt smoking is related to the risk of initiating cigarettes, e-cigarettes, and cigars. METHODS: We obtained data on a nationally representative, non-institutionalized, civilian cohort of US residents aged 12 years and older who had never used cigarettes, e-cigarettes, or any cigar at baseline and surveyed annually for three years from the Population Assessment of Tobacco and Health Study. We estimated the proportional hazard (odds) of initiating these tobacco products associated with past-year blunt smoking, non-blunt cannabis use, or neither using discrete-time survival analyses. RESULTS: Smoking blunts increased the risk of starting cigarettes (OR = 4.5), e-cigarettes (OR = 3.7), and cigars (OR = 6.7) compared to using neither blunts nor cannabis. Non-blunt cannabis use also increased the risk of starting cigarettes (OR = 4.0) but moderately for e-cigarettes (OR = 2.8) and any cigar (OR = 2.2). Blunt use was strongly related to starting combustible tobacco (cigarettes or cigars; OR = 9.0) and any three tobacco products (OR = 10.9). Exploratory findings showed that cigarillos drove cigar results and effect modification by age, race/ethnicity, and sex. CONCLUSIONS: People who smoke blunts risk starting cigarettes, e-cigarettes, and cigars more than those who abstain from cannabis. Blunts may contribute to tobacco initiation above cannabis alone.

Tobacco Use, Nicotine Dependence, and Cessation Methods in US Adults With Psychosis.

Importance: Adults with psychotic disorders have high premature mortality, partly due to the high prevalence of smoking in this population. Yet recent data are lacking on tobacco product use among US adults with a history of psychosis. Objective: To examine the sociodemographic characteristics and behavioral health status; types of tobacco products used; prevalence of use by age, sex, and race and ethnicity; and nicotine dependence severity and smoking cessation methods among community-dwelling adults with vs without psychosis. Design, Setting, and Participants: This cross-sectional study analyzed nationally representative, self-reported, cross-sectional data of adults (aged ≥18 years) who participated in the Wave 5 survey (conducted from December 2018 to November 2019) of the Population Assessment of Tobacco and Health (PATH) Study. Data analyses were conducted between September 2021 and October 2022. Exposure: PATH Study respondents were classified as having lifetime psychosis if they answered yes to whether they had ever received from a clinician (eg, physician, therapist, or other mental health professional) a diagnosis of schizophrenia, schizoaffective disorder, psychosis, or psychotic illness or episode. Main Outcomes and Measures: Use of any and major types of tobacco products, severity of nicotine dependence, and cessation methods. Results: Among the 29 045 community-dwelling adults who participated in the PATH Study (weighted median [IQR] age, 30.0 [22.0-50.0] years; weighted percentage estimates: 14 976 females (51.5%); 16.0% Hispanic, 11.1% non-Hispanic Black, 65.0% non-Hispanic White, and 8.0% non-Hispanic other race and ethnicity [American Indian or Alaska Native, Asian, Native Hawaiian or other Pacific Islander, and more than 1 race]), 2.9% (95% CI, 2.62%-3.10%) reported receiving a lifetime psychosis diagnosis. Compared with those without psychosis, people with psychosis had a higher adjusted prevalence of past-month any tobacco use (41.3% vs 27.7%; adjusted risk ratio [RR], 1.49 [95% CI, 1.36-1.63]) as well as cigarette smoking, e-cigarette use, and other tobacco product use overall and in most examined subgroups; they also had a higher past-month prevalence of dual cigarette and e-cigarette use (13.5% vs 10.1%; P = .02), polycombustible tobacco use (12.1% vs 8.6%; P = .007), and polycombustible and noncombustible tobacco use (22.1% vs 12.4%; P < .001). Among adults with past-month cigarette use, those with vs without psychosis had a higher adjusted mean nicotine dependence scores overall (54.6 vs 49.5; P < .001) and within the 45-years-or-older (61.7 vs 54.9; P = .002), female (56.9 vs 49.8; P = .001), Hispanic (53.7 vs 40.0; P = .01), and Black (53.4 vs 46.0; P = .005) groups. They were also more likely to make a quit attempt (60.0% vs 54.1%; adjusted RR, 1.11 [95% CI, 1.01-1.21]) and use counseling, a quitline, or a support group for tobacco cessation (5.6% vs 2.5%; adjusted RR, 2.25 [95% CI, 1.21-3.30]). Conclusions and Relevance: In this study, the high prevalence of tobacco use, polytobacco use, and making a quit attempt as well as the severity of nicotine dependence among community-dwelling adults with a history of psychosis highlighted the urgency for tailored tobacco cessation interventions for this population. Such strategies must be evidence-based and age, sex, and race and ethnicity appropriate.

Association between tobacco product use and asthma among US adults from the Population Assessment of Tobacco and Health (PATH) Study waves 2-4.

BACKGROUND: Research on cigarettes and adult asthma offers mixed findings, perhaps due to overlap with chronic obstructive pulmonary disease (COPD) and inadequate adjustment for other smoke exposures. Associations between other tobacco products, including e-cigarettes, and asthma are also understudied. RESEARCH QUESTION: Using Population Assessment of Tobacco and Health Study waves 2-4 (2014/2015-2016/2017) data, we assessed the relation between tobacco product use and asthma in persons unlikely to have COPD. STUDY DESIGN AND METHODS: Prospective study of 10 267 adults aged 18-39 years without COPD diagnoses. Past-month tobacco use at wave 2 was modelled first as combustible versus non-combustible use and second as specific product categories (former, cigarettes, e-cigarettes, cigars, hookah, smokeless tobacco). Outcomes included lifetime asthma prevalence at wave 2, incidence (waves 3 and 4) and Asthma Control Test score (lower=worse). Multivariable regressions adjusted for predictors of asthma, including other smoke exposures: cigarette pack-years, secondhand smoke and marijuana use. Sensitivity analyses examined findings when persons >39 years and those with both COPD and asthma were added, and when smoke exposure adjustments were removed. RESULTS: No product, including cigarettes and e-cigarettes, was associated with prevalence or incidence of asthma. Among people with asthma at wave 2, combustible tobacco (beta=-0.86, 95% CI (-1.32 to -0.39)) and cigarettes (beta=-1.14, 95% CI (-1.66 to -0.62)) were associated with worse asthma control. No tobacco product was associated with asthma control over time. In sensitivity analyses, tobacco use became associated with incident asthma as adults >39 years and those with asthma+COPD were added, and as adjustments for other smoke exposures were omitted. INTERPRETATION: Although cigarette use was associated with worse asthma control, there were no longitudinal associations between combustible tobacco or e-cigarette use and new onset or worsening asthma in these preliminary analyses. Research on tobacco and asthma should exclude COPD and adjust for smoking history and other smoke exposures.

Tobacco, Alcohol, Cannabis, and Other Drug Use in the US Before and During the Early Phase of the COVID-19 Pandemic.

Importance: Information about national substance use trends among youths and adults after mid-March 2020 is limited due to constraints on surveillance during the COVID-19 pandemic. Objective: To evaluate whether substance use prevalence in the early part of the pandemic (2020) differed from the prepandemic periods of 2018 to 2019 and 2016 to 2018. Design, Setting, and Participants: This cross-sectional study was a repeated analysis of 2016 to 2020 data from a nationally representative sample of youths and adults in the Population Assessment of Tobacco and Health (PATH) Study. Participants were representative of the US civilian noninstitutionalized population. Household residents age 13 years or older were interviewed in person from 2016 to 2019 and via telephone in 2020. Exposures: Age, calendar year. Main Outcomes and Measures: Past 30-day self-reported use of any tobacco, any alcohol, binge drinking, cannabis, and any other illegal or misused prescription drugs. Results: The overall nationally representative 2020 sample included 7129 youths (ages 13-17 years), 3628 young adults (ages 18-20 years), and 8874 adults (ages ≥21 years). Comparing 2018 to 2019 with 2020 among youths, prevalence of all substances used declined (eg, cannabis use declined in those aged 16-17 years from 14.9% to 7.6%; absolute difference, -7.3 percentage points [95% CI -8.8 to -5.8 percentage points]). Among young adults, prevalence of all substances other than any alcohol decreased significantly (eg, tobacco use declined from 37.8% to 22.8%; absolute difference, -15.1 percentage points [95% CI -16.8 to -13.3 percentage points]). In adults ages 21 to 24 years, any tobacco use declined from 39.0% to 30.9% (absolute difference, -8.2 percentage points [95% CI, -10.6 to -5.7 percentage points]), and alcohol use increased from 60.2% to 65.2% (absolute difference, 5.0 percentage points [95% CI, 2.3 to 7.7 percentage points]). Among adults aged 25 years or older, any tobacco use declined from 39.0% to 30.9% (absolute difference, -8.2 percentage points [95% CI, -10.6 to -5.7 percentage points]), cannabis use increased from 11.3% to 12.4% (absolute difference, 1.2 percentage points [95% CI, 0.3 to 2.0 percentage points]), and other substance use declined from 5.8% to 3.7% (absolute difference, -2.1 percentage points [95% CI, -2.9 to -1.4 percentage points]). Conclusions and Relevance: In this cross-sectional study, substance use decreased between 2019 and 2020 among those aged 13 to 20 years; consistent declines were not seen in older persons other than tobacco use reductions, and cannabis use increased among adults ages 25 years and older. While social changes during the COVID-19 pandemic could have affected substance use, findings should be interpreted with caution due to differences in data collection methods in 2016 to 2019 and 2020.

Variability in Urinary Nicotine Exposure Biomarker Levels Between Waves 1 (2013-2014) and 2 (2014-2015) in the Population Assessment of Tobacco and Health Study.

INTRODUCTION: To date, no studies have evaluated the consistency of biomarker levels in people who smoke over a long-time period in real-world conditions with a large number of subjects and included use behavior and measures of nicotine metabolism. We evaluated the variability of biomarkers of nicotine exposure over approximately a 1-year period in people who exclusively smoke cigarettes, including intensity and recency of use and brand switching to assess impact on understanding associations with product characteristics. AIMS AND METHODS: Multivariate regression analysis of longitudinal repeated measures of urinary biomarkers of nicotine exposure from 916 adults in the Population Assessment of Tobacco and Health (PATH) Study with demographic characteristics and use behavior variables. Intraclass correlation coefficients (ICCs) were calculated to examine individual variation of nicotine biomarkers and the uncertainty of repeat measures at two time points (Waves 1 and 2). RESULTS: Age, race, and urinary creatinine were significant covariates of urinary cotinine. When including use behavior, recency, and intensity of use were highly significant and variance decreased to a higher extent between than within subjects. The ICC for urinary cotinine decreased from 0.7530 with no use behavior variables in the model to 0.5763 when included. Similar results were found for total nicotine equivalents. CONCLUSIONS: Urinary nicotine biomarkers in the PATH Study showed good consistency between Waves 1 and 2. Use behavior measures such as time since last smoked a cigarette and number of cigarettes smoked in the past 30 days are important to include when assessing factors that may influence biomarker concentrations. IMPLICATIONS: The results of this study show that the consistency of the nicotine biomarkers cotinine and total nicotine equivalents in spot urine samples from Waves 1 to 2 of the PATH Study is high enough that these data are useful to evaluate the association of cigarette characteristics with biomarkers of exposure under real-world use conditions.

Predictors of E-cigarette and Cigarette Use Trajectory Classes from Early Adolescence to Emerging Adulthood Across Four Years (2013-2017) of the PATH Study.

INTRODUCTION: This study examines predictors of trajectories of cigarette and e-cigarette use among a cohort of US adolescents transitioning into young adulthood. Comparing trajectories of each tobacco product is important to determine if different intervention targets are needed to prevent progression to daily use. METHODS: Latent trajectory class analyses identified cigarette and e-cigarette use (never, ever excluding past 12-month, past 12-month (excluding past 30-day (P30D)), P30D 1-5 days, P30D 6+ days) trajectory classes, separately, among US youth (12-17; N = 10,086) using the first 4 waves (2013-2017) of data from the nationally representative PATH Study. Weighted descriptive analyses described the class characteristics. Weighted multinomial logistic regression analyses examined demographic, psychosocial, and behavioral predictors of class membership. RESULTS: Younger adolescents 12-15 years had lower tobacco use compared to 16-17 year olds and less stable classes. In the 16-17 year group, there were five unique trajectories of cigarette smoking, including a Persistent High Frequency class. Four e-cigarette use trajectories were identified; but not a persistent use class. Shared predictors of class membership for cigarettes and e-cigarettes included mental health problems, other tobacco use, marijuana use, and poorer academic achievement. Male sex and household tobacco use were unique e-cigarette trajectory class predictors. CONCLUSIONS: There was no evidence that initiation with e-cigarettes as the first product tried was associated with cigarette progression (nor cigarettes as first product and e-cigarette progression). Interventions should focus on well-established risk factors such as mental health and other substance use to prevent progression of use for both tobacco products. IMPLICATIONS: Using nationally representative data and definitions of use that take into account frequency and recency of use, longitudinal 4-year trajectories of e-cigarette and cigarette use among US adolescents transitioning into young adulthood were identified. Results among 16-17-year olds revealed a class of persistent high frequency cigarette smoking that was not identified for e-cigarette use. Cigarette use progression was not associated with e-cigarettes as the first product tried. Risk factors for progression of use of both products included mental health and other substance use, which are important prevention targets for both tobacco products.

RETRACTED: Changes in Tobacco Dependence and Association With Onset and Progression of Use by Product Type From Wave 1 to Wave 3 of the Population Assessment of Tobacco and Health (PATH) Study.

INTRODUCTION: This study examined trajectories of tobacco dependence (TD) in relation to changes in tobacco product use and explored the effects of product-specific adding, switching, or discontinued use on dependence over time. AIMS AND METHODS: Data were analyzed from the first three waves of the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative, longitudinal study of adults and youth in the United States. Data included 9556 Wave 1 (2013/2014) adult current established tobacco users who completed all three interviews and had established use at ≥2 assessments. Groups included cigarettes-only users, e-cigarettes-only users, cigars-only users, hookah-only users, any smokeless-only users, cigarette + e-cigarette dual users, and multiple product users. A validated 16-item scale assessed TD across product users. RESULTS: Wave 1 e-cigarette-only users' who maintained exclusive e-cigarette use increased levels of TD through Wave 3 as did those who added or switched to another product. Wave 1 multiple product users' TD decreased across waves. TD for all other Wave 1 user groups remained about the same. For Wave 1 cigarette-only smokers, switching to another product or moving to a pattern of no established use was associated with lower levels of TD than smokers whose use stayed the same. Movement to no established use of any tobacco product was consistently associated with lower TD for all other product users. CONCLUSIONS: Except for Wave 1 e-cigarette-only users, TD among US tobacco product users was stable over time, with daily users less likely to vary from baseline. IMPLICATIONS: The level of TD among most US tobacco users was stable over the first three waves of the PATH Study and trends in levels of TD were predominantly unrelated to changes in patterns of continued product use. Stable levels of TD suggest a population at persistent risk of health impacts from tobacco. Wave 1 e-cigarette users, including those maintaining exclusive e-cigarette use, experienced increasing levels of TD over time, perhaps because of increases in quantity or frequency of their e-cigarette product use or increasing efficiency of nicotine delivery over time.

NATIONAL ADDICTION AND HIV DATA ARCHIVE PROGRAM: DEVELOPING AN APPROACH FOR REUSE OF SENSITIVE AND CONFIDENTIAL DATA.

Sharing data produced through health research projects has been increasingly recognized as a way to advance science more rapidly by facilitating discovery and increasing rigor and reproducibility. Much of the data collected from human subjects includes sufficient sociodemographic detail and/or covers sensitive topics, and thus requires restricted data management and sharing practices. Over the last two decades, scientific organizations, presidential memoranda, and other sources have all called for increasing opportunities to share data. Recognizing the value of shared data, the National Institutes of Health issued a new Data Management and Sharing Policy, effective January 25, 2023. Prior to this updated policy, in 2009, the National Institute on Drug Abuse recognized the value of sharing data and established an archive, the National Addiction and HIV Data Archive Program. This program focused on sharing data, often highly sensitive, generated from social and behavioral addiction research, including quantitative and qualitative assessments as well as biomarker and imaging data. NAHDAP has developed practices and curation standards to ensure datasets are improved and usable, and provides technical assistance for both data depositors and users. We share three key lessons learned working to disseminate sensitive data over the last 13 years, including (1) protecting the confidentiality of human subjects; (2) ensuring careful consideration of costs for archiving data requiring protection ; and (3) providing support to facilitate the discovery and use of the data.

Tobacco Use and Incidence of Adverse Oral Health Outcomes Among US Adults in the Population Assessment of Tobacco and Health Study.

Importance: Evolving tobacco use patterns, including increasing electronic nicotine delivery systems (ENDS) use, warrant re-examination of the associations between tobacco use and oral health. Objective: To examine associations between tobacco product use and incidence of adverse oral health outcomes. Design, Setting, and Participants: This cohort study used nationally representative data from wave (W) 1 to W5 (2013-2019) of the Population Assessment of Tobacco and Health Study. Recruitment used a stratified address-based, area-probability household sample of the noninstitutionalized US civilian population. The W1 cohort included respondents aged 18 years and older without lifetime history of oral health outcomes at W1 or W3, depending on when the outcome was first assessed. Data analysis was performed from October 2021 to September 2022. Exposures: Current (every day or someday use) established (lifetime use of at least 100 cigarettes or "fairly regular" use of other products) use of cigarettes, ENDS, cigars, pipes, hookah, snus, and smokeless tobacco, excluding snus at W1 to W4. Main Outcomes and Measures: The primary outcomes were past 12-month self-reported diagnosis of gum disease and precancerous oral lesions (W2-W5) and bone loss around teeth, bleeding after brushing or flossing, loose teeth, and 1 or more teeth removed (W4-W5). Results: Sample sizes varied across the 6 oral health outcomes (13 149 respondents for the gum disease sample, 14 993 respondents for the precancerous oral lesions sample, 16 312 respondents for the bone loss around teeth sample, 10 286 respondents for the bleeding after brushing or flossing sample, 15 686 respondents for the loose teeth sample, and 12 061 respondents for the 1 or more teeth removed sample). Slightly more than half of adults (52%-54% across the 6 samples) were women, and the majority were of non-Hispanic White race and ethnicity. Cox proportional hazards models were developed with covariates that included time-dependent tobacco use variables mutually adjusted for each other. Cigarette smoking was positively associated with incidence of gum disease diagnosis (adjusted hazard ratio [AHR], 1.33; 95% CI, 1.11-1.60), loose teeth (AHR, 1.35; 95% CI, 1.05-1.75), and 1 or more teeth removed (AHR, 1.43; 95% CI, 1.18-1.74). Cigar smoking was positively associated with incidence of precancerous oral lesions (AHR, 2.18; 95% CI, 1.38-3.43). In addition, hookah smoking was positively associated with incidence of gum disease diagnosis (AHR, 1.78; 95% CI, 1.20-2.63), and ENDS use was positively associated with incidence of bleeding after brushing or flossing (AHR, 1.27; 95% CI, 1.04-1.54). No associations were observed between snus and smokeless tobacco excluding snus and incidence of oral health outcomes. Conclusions and Relevance: The observed associations of combustible tobacco use with incidence of several adverse oral health outcomes and ENDS use with incidence of bleeding after brushing or flossing highlight the importance of longitudinal studies and emphasize the continued importance of tobacco cessation counseling and resources in clinical practice.

Association of tobacco product use with chronic obstructive pulmonary disease (COPD) prevalence and incidence in Waves 1 through 5 (2013-2019) of the Population Assessment of Tobacco and Health (PATH) Study.

BACKGROUND: We examined the association of non-cigarette tobacco use on chronic obstructive pulmonary disease (COPD) risk in the Population Assessment of Tobacco and Health (PATH) Study. METHODS: There were 13,752 participants ≥ 40 years with Wave 1 (W1) data for prevalence analyses, including 6945 adults without COPD for incidence analyses; W1-5 (2013-2019) data were analyzed. W1 tobacco use was modeled as 12 mutually-exclusive categories of past 30-day (P30D) single and polyuse, with two reference categories (current exclusive cigarette and never tobacco). Prevalence and incidence ratios of self-reported physician-diagnosed COPD were estimated using weighted multivariable Poisson regression. RESULTS: W1 mean (SE) age was 58.1(0.1) years; mean cigarette pack-years was similar for all categories involving cigarettes and exclusive use of e-cigarettes (all > 20), greater than exclusive cigar users (< 10); and COPD prevalence was 7.7%. Compared to P30D cigarette use, never tobacco, former tobacco, and cigar use were associated with lower COPD prevalence (RR = 0.33, (95% confidence interval-CI) [0.26, 0.42]; RR = 0.57, CI [0.47, 0.70]; RR = 0.46, CI [0.28, 0.76], respectively); compared to never tobacco use, all categories except cigar and smokeless tobacco use were associated with higher COPD prevalence (RR former = 1.72, CI [1.33, 2.23]; RR cigarette = 3.00, CI [2.37, 3.80]; RR e-cigarette = 2.22, CI [1.44, 3.42]; RR cigarette + e-cigarette = 3.10, CI [2.39, 4.02]; RR polycombusted = 3.37, CI [2.44, 4.65]; RR polycombusted plus noncombusted = 2.75, CI]1.99, 3.81]). COPD incidence from W2-5 was 5.8%. Never and former tobacco users had lower COPD risk compared to current cigarette smokers (RR = 0.52, CI [0.35, 0.77]; RR = 0.47, CI [0.32, 0.70], respectively). Compared to never use, cigarette, smokeless, cigarette plus e-cigarette, and polycombusted tobacco use were associated with higher COPD incidence (RR = 1.92, CI [1.29, 2.86]; RR = 2.08, CI [1.07, 4.03]; RR = 1.99, CI [1.29, 3.07]; RR = 2.59, CI [1.60, 4.21], respectively); exclusive use of e-cigarettes was not (RR = 1.36, CI [0.55, 3.39]). CONCLUSIONS: E-cigarettes and all use categories involving cigarettes were associated with higher COPD prevalence compared to never use, reflecting, in part, the high burden of cigarette exposure in these groups. Cigarette-but not exclusive e-cigarette-use was also strongly associated with higher COPD incidence. Compared to cigarette use, only quitting tobacco was protective against COPD development.