Pilot randomised controlled trial of a culturally aligned smoking cessation app for American Indian persons.

OBJECTIVE: To pilot test QuitGuide for Natives, a culturally aligned version of the National Cancer Institute's QuitGuide smartphone app for smoking cessation. METHODS: This randomised controlled trial was conducted remotely during 2022-2023. American Indian adults who smoked and resided in the Midwest (n=115) were randomised to QuitGuide for Natives or the general audience QuitGuide smartphone-based intervention. Group differences in feasibility (times the app was initiated), usability, acceptability ('How likely would you be to recommend the app to a friend?'), fit of app with culture and preliminary efficacy (24-hour quit attempts, cotinine-confirmed self-reported 7-day abstinence) outcomes were examined. RESULTS: QuitGuide for Natives versus the general audience QuitGuide did not differ in the number of times the app was opened (adjusted incidence rate ratio 0.94 (95% CI 0.63 to 1.40); p=0.743) nor in usability score (adjusted mean difference (aMD) 0.73 (95% CI: -5.00 to 6.46); p=0.801) or likeliness of recommending the app to a friend (aMD 0.62 (95% CI -0.02 to 1.27); p=0.058). Differences were observed for all cultural fit outcomes such as 'The app fits my American Indian culture (aMD 0.75 (95% CI 0.35 to 1.16); p<0.001). QuitGuide for Natives versus the general audience QuitGuide resulted in an average of 6.6 vs 5.1 24-hour quit attempts (p=0.349) and cotinine-confirmed 7-day abstinence was achieved by 6.9% vs 3.5% (p=0.679). CONCLUSIONS: Acceptability, cultural fit and preliminary efficacy findings are encouraging and will inform future, larger-scale evaluation of culturally aligned digital smoking cessation resources for American Indian adults.

Reduced nicotine in cigarettes in a marketplace with alternative nicotine systems: randomized clinical trial.

Background: Reducing cigarette addictiveness has the potential to avert millions of yearly tobacco-related deaths worldwide. Substantially reducing nicotine in cigarettes decreases cigarette consumption, but no large clinical trial has determined the effects of reduced-nicotine cigarettes when other nicotine-containing products are available. The aim of this study was to examine the effects of reduced-nicotine cigarettes in the context of the availability of alternative nicotine delivery systems. Methods: In a U.S. six-site, open-label, parallel-arm study, smokers were randomized for twelve weeks to an experimental marketplace containing cigarettes with either 0.4 mg or 15.8 mg nicotine per gram of tobacco; all had access to non-combusted alternative nicotine delivery systems (e.g., e-cigarettes; medicinal nicotine). Group differences in the primary outcomes (cigarettes per day, number of smoke-free days) were examined using linear and negative binomial regression, respectively (Trial Registration: NCT03272685). Findings: Among 438 randomized participants (mean [standard deviation (SD), range] age, 44.5 [11.9, 20-73] years, 225 [51.4%] women, 282 [64.4%] White and 339 [77.4%] trial completers), those in the 0.4 mg vs. 15.8 mg nicotine cigarette condition experienced significantly lower cigarettes per day at the end of intervention (mean [SD], 7.05 [7.88] vs. 12.95 [9.07], adjusted mean difference, -6.21 [95% CI, -7.66 to -4.75], P < 0.0001) and greater smoke-free days during intervention (mean [SD], 18.59 [27.97] vs. 5.06 [13.77], adjusted rate ratio, 4.25 [95% CI, 2.58-6.98], P < 0.0001). Interpretation: A reduced-nicotine cigarette standard in the context of access to other non-combusted nicotine products has the potential to benefit public health. Funding: U.S. NIH/FDA U54DA03165.

Menthol and filter ventilation in cigarettes: prevalence estimates and relationships with harm perception and smoking exposure.

INTRODUCTION: Menthol and filter ventilation (FV) contribute to cigarette appeal. This observational study examines the US prevalence of menthol versus non-menthol cigarette use by FV and how harm perceptions, cigarettes per day and biomarkers of exposure vary. METHODS: Population Assessment of Tobacco and Health Study (2013-2014) was merged with FV levels of cigarettes and restricted to daily smoking adults who had a usual cigarette variety and did not regularly use other tobacco (N=1614). Weighted descriptive statistics identified the prevalence of menthol and non-menthol use by low (0.02%-10.04%), moderate (10.05%-23.40%), high (23.41%-28.12%) and very high FV (28.13%-61.10%). Weighted linear regression was used to examine differences in outcomes by menthol/FV adjusted for potential confounders. RESULTS: The prevalence of a usual brand that was non-menthol, low FV was the lowest at 2.91%. Using non-menthol cigarettes with high and very high FV (≥23.4%) vs low FV (≤10.04%) was associated with a greater likeliness of misperceiving one's cigarette variety to be less harmful than other varieties (p values<0.05). Total nicotine equivalent, biomarker for nicotine exposure, was elevated (p values<0.05) among three non-menthol groups (low, moderate and very high FV) compared with two menthol groups (moderate, very high FV). CONCLUSION: The well-documented harm misperception linked to higher FV is more apparent in those using non-menthol than menthol cigarettes. Increased exposures were observed among some non-menthol cigarette users compared with some menthol cigarette users. These results should by no means delay a menthol ban but rather motivate concerted public health efforts to accompany the menthol ban to maximise smoking cessation.

American Indian Perspectives on Culturally Aligning a Digital Smoking Cessation Resource.

INTRODUCTION: Innovative smoking cessation approaches that overcome barriers such as traveling to program site or that require the staff and infrastructure for sustaining are likely needed to improve smoking quit rates among American Indian (AI) peoples in the United States. In this study, qualitative methods identified recommendations from AI peoples to guide alignment of an evidence-based smoking cessation smartphone app (i.e., QuitGuide) to the culture and needs of AI persons. METHODS: Semi-structured interviews were conducted with AI adults who smoke (n = 40) and with public health professionals (n = 6). Questions included: "The app asks if something triggered you to slip and lists several options. What options were you expecting to see on this list?" as well as how to make the app more engaging such as "What would make the app more helpful for AI peoples, like you, who want to quit smoking?." Constant comparative techniques were used to develop codes and themes. RESULTS: Loss, grief, and not accessing traditional tobacco were put forward as smoking triggers to be addressed in the app. Features that help users connect with and learn about AI cultures and promote healing, such as encouraging traditional tobacco use, being in community, embracing Native spirituality, and participating in cultural crafting were recommended. Some noted the need to motivate AI peoples to think about legacy and ability to care for younger generations and Indigenizing the app with Native imagery. CONCLUSIONS: Themes pointed towards promotion of strengths-based factors, such as healing, cultural connectedness and traditional tobacco use, in the app. IMPLICATIONS: Results will be used to culturally align a smartphone app for smoking cessation among AI peoples and may be insightful for other tribal, federal, and state public health efforts aimed at advancing health equity for AI peoples.

Smoking Quit Attempts and Associated Factors Among Rural Adults Who Smoke Daily in the US.

INTRODUCTION: Rural American communities are heavily affected by tobacco-related health disparities. This study aims to evaluate the prevalence of quit attempts (QA) and factors that promote or impede QA among rural adults who smoke daily. METHODS: Data from Wave 5 of the Population Assessment of Tobacco and Health study were analyzed. Multivariable logistic regression was used to identify factors associated with quit attempt. Backwards selection was used to identify variables included in the final model with statistical significance set at p <0.05. RESULTS: Among 1,610 rural adults who smoked daily, the prevalence of a quit attempt in the past 12 months was 25.6% (95% CI: 23.2, 28.2). Factors associated with greater QA odds: having greater education (aOR = 1.35, 95% CI: 1.03, 1.77), e-cigarette use (aOR=1.35 95% CI: 1.03, 1.80), disapproval of smoking from friends/family (aOR= 1.46, 95% CI: 1.09-1.94), greater frequency of thinking about the harm of tobacco (aOR = 1.48, 95% CI: 1.28, 1.71), fair/poor physical health (aOR=1.31, 95% CI: 1.00, 1.70), and being advised to quit by a doctor (aOR =1.63 , 95% CI:1.25, 2.13). Smokeless tobacco use (aOR = 0.67, 95% CI: 0.47, 0.96) and greater cigarettes per day (aOR = 0.67, 95% CI: 0.47, 0.96) were associated with QA lower odds. CONCLUSION: Only 1 in 4 rural adults who smoke made a past year quit attempt. Interventions that promote provider advice to quit smoking, tobacco health harms, and normative beliefs may increase quit attempts in rural communities. IMPLICATIONS: Along with higher smoking rates and lower quitting attempts, rural communities face limited access to programs, medication, and health care professionals as tools to help them quit smoking. Public Health initiatives should focus on developing cultural sensitivity training targeting health care professionals to advise patients to quit smoking and the role of multiple tobacco products use. Furthermore, given the low rates of smoking quitting attempts future mixed methods research is needed to inform policies and interventions targeted at eliminating tobacco-related health disparities.

Older age is associated with greater misperception of the relative health risk of e-cigarettes and cigarettes among US adults who smoke.

INTRODUCTION: The prevalence of cigarette smoking among adults aged ≥55 has remained stagnant over the past decade. National data modelling suggests no reduction in cigarette smoking prevalence attributable to e-cigarette use in the USA among people aged ≥45. Misperceptions about the absolute risks (ie, cigarettes are not harmful) and relative risks (ie, e-cigarettes are more harmful than cigarettes) of tobacco products may contribute to sustained smoking prevalence and hesitancy to switch from cigarettes to e-cigarettes among older adults. METHODS: Participants reported cigarette use (n=8072) at Wave 5 (2018-2019) of the Population Assessment of Tobacco and Health Study. Weighted multivariable logistic regressions included six age categories (independent variable) and cigarette and e-cigarette risk perceptions (outcomes). Additional models assessed the associations between dichotomous age (≥55 vs 18-54), risk perceptions and an interaction term (independent variables) with past 12-month quit attempts and past-month e-cigarette use (outcomes). RESULTS: Adults aged ≥65 were less likely than adults aged 18-24 to rate cigarettes as very/extremely harmful (p<0.05). Odds of rating e-cigarettes as more harmful than cigarettes among adults aged 55-64 and ≥65 were 1.71 (p<0.001) and 1.43 (p=0.024) greater than for adults aged 18-24. This misperception was negatively associated with past-month e-cigarette use and was stronger among adults aged ≥55 (p<0.001) than adults aged <55 (p<0.001). DISCUSSION: Adults aged ≥55 are more likely to have misperceptions about the absolute and relative risks of tobacco products, which may contribute to continued smoking. Health communications targeting this age group could modify beliefs about the perceived harms of tobacco products.

Feasibility of mailed biomarker data collection among U.S. young adults: Saliva-based cotinine and self-reported nicotine use.

BACKGROUND: Nationally representative self-report studies are the standard for data on the prevalence of substance use. Newly emerging biomarker assessments can add objective measurements of exposure. However, biomarker assessment has typically depended on in-person sample collection. The current study examined whether young adults in a national sample would be willing and able to provide a saliva sample via mail, and the correspondence of cotinine in the saliva sample with self-reported vaping and smoking. METHODS: Data collection for the Monitoring the Future (MTF) Vaping Supplement was from September to November 2020. Eligible participants (N = 4358) were selected from a nationally-representative sample of US 12th-grade students in MTF in spring 2019. The MTF Vaping Supplement surveyed individuals nationally about one year after the 12th grade MTF survey (in 2020, mean age = 19.6 years; N = 1244). Survey weights accounted for design and attrition. RESULTS: Of those surveyed, 66.2% consented to provide a saliva sample and, of those, 73.8% mailed a sample. There were no significant differences in providing a saliva sample across any demographic characteristic, but those who reported nicotine use were less likely to provide a sample. Cotinine cut-off measures of > 3 ng/mL and > 10 ng/mL had good correspondence with self-reported measures. CONCLUSIONS: Results support the feasibility of collecting saliva via the mail in a national sample and the validity of data collected in this way. These findings support future research innovations to expand existing survey research protocols to include biomarker data collection in representative samples of young adults.

Switching to cigarette brand variants with different filter ventilation levels: a descriptive analysis.

BACKGROUND: Regulation of filter ventilation (FV) has been proposed to reduce misperceptions that ventilation reduces the health risks of smoking. We describe smoking behaviour and exposure after switching to a cigarette brand variant (CBV) with a different FV level. METHODS: Wave 1 (2013-2014) of the Population Assessment of Tobacco Use and Health Study was merged with FV levels of participants' CBV and restricted to adults with a usual CBV, smoked daily and included in wave 4 (2016-2017; n=371). Generalised estimation equations method modelled changes in FV and cigarettes per day (CPD), quit interest, total nicotine equivalents (TNE) and total NNAL (biomarker of a tobacco-specific carcinogen). FV change was defined as a change in CBV resulting in a ≥20% increase or decrease in FV. Secondary analyses used FV change based on an increase from <5% to >10% or a decrease from >10% to <5%. RESULTS: A non-significant pattern indicating an increase of 0.97 and 0.49 CPD was observed among those who switched to a CBV and increased FV by ≥20% and from <5% to >10%, respectively. A non-significant pattern indicating a decrease of 1.31 and 1.97 CPD was observed among those who decreased FV by ≥20% and from >10% to <5%, respectively. Changes in quit interest and biomarkers were also non-significant with one exception: greater reduction in TNE among those who decreased from >10% to <5% FV versus no change (-8.51 vs -0.25 nmol/mg creatinine; p=0.0447). CONCLUSIONS: Switching to CBV with lower FV does not appear to increase exposure and may even reduce exposure for some. Additional investigations are recommended to confirm these descriptive findings.

Risk perceptions and continued smoking as a function of cigarette filter ventilation level among US youth and young adults who smoke.

BACKGROUND: While evidence demonstrates that the industry's marketing of cigarettes with higher filter ventilation (FV) misleads adults about their health risks, there is no research on the relationships between FV, risk perceptions and smoking trajectories among youth (ages 12-17) and young adults (ages 18-24). METHODS: Data on FV levels of major US cigarette brands/sub-brands were merged with the Population Assessment of Tobacco and Health Study to examine whether FV level in cigarettes used by wave 1 youth/young adults (n=1970) predicted continued smoking at waves 2-4, and whether those relationships were mediated by perceived risk of their cigarette brand. FV was modelled based on tertiles (0.2%-11.8%, low; 11.9%-23.2%, moderate; 23.3%-61.1%, high) to predict daily smoking, past 30-day smoking and change in number of days smoking at successive waves. RESULTS: The odds of perceiving one's brand as less harmful than other cigarette brands was 2.21 times higher in the high versus low FV group (p=0.0146). Relationships between FV and smoking outcomes at successive waves were non-significant (all p>0.05). CONCLUSION: Youth and young adults who use higher FV cigarettes perceived their brand as less harmful compared with other brands. However, level of FV was not associated with continued smoking.

Exploring Potential for a Personalized Medicine Approach to Smoking Cessation With an American Indian Tribe.

INTRODUCTION: A potential precision medicine approach to smoking cessation is tailoring pharmacotherapy to a biomarker known as the nicotine metabolite ratio (NMR). Little is known about the potential impact and acceptability of this approach for American Indian (AI) persons. AIMS AND METHODS: Tribal-academic collaboration was formed and during 2019-2020 AI adults who smoke(N = 54) were recruited to (1) examine correlations between NMR, dependence, and smoking exposure; (2) assess the extent to which pharmacotherapy preference aligned with NMR-informed recommendations; (3) explore acceptability of NMR-informed pharmacotherapy selection. Participants provided samples for assessment of salivary NMR and urinary total nicotine equivalents (TNE) and completed a questionnaire that assessed cigarettes per day (CPD), Fagerstrom Test for Cigarette Dependence (FTCD), pharmacotherapy preference, and perceptions of NMR-informed pharmacotherapy selection. RESULTS: Significant positive correlations were observed between NMR and FTCD (r = 0.29;p = .0383) and its abbreviated version Heaviness of Smoking Index (HIS) (r = 0.28;p =.0426). Post-hoc analyses suggest that relationships between dependence and NMR were driven by time to first cigarette. Nonsignificant, but directionally consistent, relationships were observed between NMR and CPD (r = 0.21; p =0.1436) and TNE (r = 0.24;p = .2906). Most participants preferred nicotine replacement therapy (71%) over varenicline (29%) and preference for pharmacotherapy matched NMR-based recommendations in 54% of participants. NMR-informed pharmacotherapy selection was supported by 62% of participants. CONCLUSION: In a sample of AI adults who smoke, NMR was related to cigarette dependence and about one-half of participants' pharmacotherapy preference matched their NMR-informed recommendation. There was lower acceptability of NMR-informed approach in this sample of AI adults than prior studies among white or black/African American people who smoke. IMPLICATIONS: Relationships between NMR, dependence, and self-preference for pharmacotherapy suggest that NMR-informed pharmacotherapy selection may have potential for enhancing smoking quitting success in this Tribe. Lower acceptability of NMR-informed pharmacotherapy in this Tribe suggests that this approach may not be equitably utilized. Future work could include identifying community-driven solutions to mitigate precision medicine concerns.

Educating the Public on the Health Risks of Very Low Nicotine Content Cigarettes: Results From a US-Based Convenience Sample.

INTRODUCTION: US FDA issued an advance notice of proposed rulemaking to reduce nicotine in cigarettes. To maximize the benefits of this potential standard, very low nicotine content (VLNC) cigarettes must be communicated in a way that does not result in misperceptions. AIMS AND METHODS: Adults (n = 567 who smoke; n = 610 non-smokers) from an online platform were randomized to a control message previously associated with accurate addictiveness perceptions of VLNC cigarettes but health misperceptions or to one of five messages that also included messaging on nicotine morbidity effects or VLNC cigarettes morbidity or mortality effects. p value <.01 was significant. RESULTS: In participants who smoke, perceived lung cancer risk (responses: 1, very little risk to 10, very high risk) if smoked VLNC cigarettes regularly was higher in conditions that communicated mortality effects of VLNC cigarettes compared to the control (7.12-7.18 vs. 5.97, p values < .01). In non-smokers, perceived lung cancer risk was higher in all five message conditions when compared with the control (7.58-8.22 vs. 6.35, p values < .01). Proportion who responded accurately (ie, False) to the statement Cigarettes with 95% less nicotine are safer than cigarettes with normal nicotine levels was higher in conditions describing VLNC morbidity or mortality effects when compared with the control in both participants who smoke (52.04-67.37% vs. 30.85%, p values < .01) and do not smoke (62.50-72.38% vs. 32.00%, p values < .01). CONCLUSIONS: Messaging on mortality effects of VLNC cigarettes (ie, cigarettes with 95% less nicotine are as deadly as current cigarettes) was associated with more accurate perceptions of the health risks of VLNC cigarettes than the control; however, misperceptions remained in one-third of participants. IMPLICATIONS: One approach to communicating a VLNC cigarette standard to the public is to include messaging on the mortality effects of VLNC cigarettes. However, further study and possible refinement of this message condition are recommended since approximately one-third of participants exposed to this message still perceived VLNC cigarettes to be safer than normal nicotine content cigarettes.

Racial/ethnic group comparisons of quit ratios and prevalences of cessation-related factors among adults who smoke with a quit attempt.

BACKGROUND: Smoking-related disparities exist among racial/ethnic minoritized groups. OBJECTIVE: We compared quit ratios and smoking cessation-related protective and risk factors by race/ethnicity to inform approaches to reduce disparities. METHODS: Among adults who smoke with a quit attempt from Wave 4 (2016-2017) Population Assessment of Tobacco Use and Health Study, the following factors were examined by racial/ethnic group (American Indians/Alaska Native [AI/AN;n = 165], Black/African American [AA;n = 526], Asian [n = 38], Hispanic/Latino/Latina/Spanish [n = 475], or White [n = 1,960]), wherein each were nearly gender-balanced: cessation medications, counseling/self-help materials, home smoking ban, social support, e-cigarette use, sleep, and mental health. RESULTS: Quit ratio was lower for AI/AN (adjusted odds ratio[aOR]:0.61) and Black/AA (aOR:0.49) and higher for Asian (aOR:1.90) and Hispanic/Latino/Latina/Spanish (aOR:1.30) than White adults. Medication use was low among all and lower among Black/AA (aOR:0.70) and Hispanic/Latino/Latina/Spanish (aOR:0.56) than White adults. Use of counseling/self-help materials were low among all and higher in AI/AN (aOR:1.85), Black/AA (aOR:1.87), and Hispanic/Latino/Latina/Spanish (aOR:1.49) than White adults. Presence of a smoking ban was lower among Black/AA (aOR:0.40) and higher in Hispanic/Latino/Latina/Spanish (aOR:1.59) than White adults. E-cigarette use was lower in Black/AA (aOR:0.53) and Hispanic/Latino/Latina/Spanish (aOR:0.43) than White adults. Sadness, anxiety, and sleep difficulties were higher in AI/AN (aORs:1.57, 1.50, 1.64) than White adults. CONCLUSIONS: All racial/ethnic groups would benefit from policies and programs that increase cessation medications and counseling. Quit ratios were particularly low among Black/AA and AI/AN adults. Black/AA adults may benefit from efforts to increase smoking bans, while AI/AN adults may benefit from cessation approaches that simultaneously target sleep and mental health.

Risk Perceptions of Low Nicotine Cigarettes and Alternative Nicotine Products across Priority Smoking Populations.

BACKGROUND: As the U.S. Food and Drug Administration considers a low nicotine product standard for cigarettes, it is important to examine how people who smoke, especially individuals from priority populations disproportionately affected by smoking, perceive low nicotine content (LNC) cigarettes and their relative risk perceptions of alternative nicotine delivery system (ANDS) products, including e-cigarettes and snus, and medicinal nicotine. METHODS: Data are from Wave 4 (2016-2017) of the adult Population Assessment of Tobacco Use and Health (PATH) Study. We examined respondents' absolute risk perceptions about nicotine, LNC cigarettes, ANDS products and medicinal nicotine; their relative risk perceptions of LNC cigarettes and ANDS products compared to conventional cigarettes; and their relative risk perceptions of medicinal nicotine compared to ANDS products. RESULTS: The majority of respondents across priority smoking populations indicated snus, e-cigarettes, and LNC cigarettes were 'about the same' level of harmfulness or addictiveness as conventional cigarettes. The majority of respondents indicated e-cigarettes to be 'about the same' harmfulness as medicinal nicotine. CONCLUSIONS: Our study indicates that adults who smoke cigarettes generally have misperceptions about the harms of nicotine and the relative risks of ANDS products and such misperceptions exist regardless of their racial/ethnic identity, sexual orientation, and gender identity.

Tobacco Industry Marketing Exposure and Commercial Tobacco Product Use Disparities among American Indians and Alaska Natives.

Background: Non-Hispanic American Indians and Alaska Natives (NH AI/AN) have the highest commercial tobacco use (CTU) among U.S. racial/ethnic groups. Tobacco marketing is a risk factor, however few studies examine it among NH AI/AN. Objective: We identified prevalence of tobacco industry marketing exposure and correlates of CTU among NH AI/AN compared to other racial/ethnic groups. Methods: Data were from wave 1 (2013-2014; N = 32,320) of the Population Assessment of Tobacco and Health Study, analyzing self-reported exposure to tobacco ads from stores, tobacco package displays, direct mail and email marketing. Correlates of CTU were identified and interactions between racial/ethnic groups and tobacco marketing were assessed. Results: NH AI/AN (n = 955) had a higher prevalence of exposure to retail tobacco ads (64.5% vs 59.3%; p < 0.05), mail (20.2% vs.14.3%; p < 0.001) and email (17.0% vs.10.6%; p < 0.001) marketing than NH Whites (n = 19,297). Adjusting for tobacco use and related risk factors, exposure to email marketing remained higher among NH AI/AN than NH Whites. Interactions between racial/ethnic groups and marketing exposures on CTU were nonsignificant. CTU was higher among NH AI/AN than NH Whites and among adults who reported exposure to tobacco ads, mail, and email marketing. Conclusions/importance: There is higher tobacco marketing exposure in stores and via mail for NH AI/AN. Email marketing exposure was higher, even after controlling for tobacco-related risk factors. The tobacco industry may be targeting NH AI/AN through emails, which include coupons and other marketing promotions. Culturally relevant strategies that counter-act tobacco industry direct marketing tactics are needed to reduce disparities in this population.

Development and Piloting Testing of an Experimental Tobacco and Nicotine Product Marketplace.

INTRODUCTION: We describe the development and pilot testing of the experimental tobacco and nicotine product marketplace (ETM)-a method for studying tobacco and nicotine product (TNP) choices and use behavior in a standardized way. AIMS AND METHODS: The ETM resembles an online store populated with TNPs. Surveillance activities and data from a US representative survey and consumer reports were used to determine the most popular TNPs for inclusion in the ETM. Standardized information and videos demonstrating how to use the TNPs were provided. To test the feasibility of using the ETM, smokers (n = 119) underwent monitoring of usual brand cigarette smoking and other TNP use (Baseline Phase) followed by access to the ETM (ETM Phase) that included their usual brand cigarettes, e-cigarettes, moist snuff, snus, and nicotine replacement therapy. During the ETM Phase, participants were provided points based on their baseline TNP consumption to exchange for TNPs in the ETM. Participants were advised to exchange points for enough TNPs to last until their next visit and to refrain from using TNPs not obtained in the ETM. A subset of the participants (n = 62) completed a survey on their experience with the ETM. RESULTS: The majority of the participants stated they were comfortable with navigating the ETM (97%), it was easy to determine product characteristics (89%), and they were satisfied with the products included in the marketplace (85%). CONCLUSIONS: The ETM was well received by the vast majority of the participants and can be utilized by researchers to investigate a variety of TNP policy and regulatory science research questions. IMPLICATIONS: Patterns of TNP use are complex due to greater availability, marketing, and promotion of a diverse array of TNPs. Innovative methods are needed to experimentally study TNP choices and patterns. Through describing the development of the ETM, we provide researchers with a tool that can be readily adapted to studying a variety of phenomena challenging public health.

The relationship between nicotine metabolism and nicotine and carcinogen exposure among American Indian commercial cigarette smokers and electronic nicotine delivery system users.

BACKGROUND: In American Indian (AI) tobacco users from the southern plains region of the US, we examined the relationship between nicotine and carcinogen exposure and nicotine metabolism. METHODS: Smokers (n = 27), electronic nicotine delivery system (ENDS) users (n = 21), and dual users (n = 25) of AI descent were recruited from a southern plains state. Urinary biomarkers of nicotine metabolism (nicotine metabolite ratio [NMR]), nicotine dose (total nicotine equivalents [TNE]), and a tobacco-specific lung carcinogen (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides [total NNAL] were measured. RESULTS: The geometric mean of NMR was 3.35 (95% Confidence Interval(CI): 2.42, 4.65), 4.67 (95% CI: 3.39, 6.43), and 3.26 (95% CI: 2.44, 4.37) among smokers, ENDS users, and dual users. Each of the three user groups had relatively low levels of TNE, indicative of light tobacco use. Among smokers, there were inverse relationships between NMR and TNE (r = -0.45) and between NMR and NNAL (r = -0.50). Among dual users, NMR and TNE, and NMR and NNAL were not associated. Among ENDS users, NMR and TNE were not associated. CONCLUSIONS: AI tobacco users with higher NMR did not have higher TNE or NNAL exposure than those with lower NMR. This supports prior work among light tobacco users who do not alter their tobacco consumption to account for nicotine metabolism. IMPACT: The high prevalences of smoking and ENDS among AI in the southern plains may not be related to nicotine metabolism. Environmental and social cues may play a more important role in light tobacco users and this may be particularly true among AI light tobacco users who have strong cultural ties.

Biomarkers of Exposure in ENDS Users, Smokers, and Dual Users of American Indian Descent.

Objectives: We measured biomarkers of exposure among American Indian (AI) ENDS users, smokers, and dual users. Methods: Urine was analyzed for total nicotine equivalents (TNE) and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol(NNAL). Expired-air carbon monoxide (CO) was collected. Two analyses were performed. "CO analysis" included smokers and dual users whose CO was ≥ 6 ppm and ENDS users whose CO was < 6 ppm. "NNAL analysis" included smokers and dual users whose NNAL was ≥ 47.3 pg/mg, and ENDS users whose NNAL was < 47.3 pg/mg. Biomarkers were summarized by geometric means (GM) and compared with nonparametric tests. Results: In both analyses, TNE was no different across the groups, and NNAL and CO were lower in ENDS users. In the NNAL analysis the GM of NNAL was 261.4, 6.1, and 228.0 pg/mg among smokers, ENDS users, and dual users (p < .001). Also in the NNAL analysis, the GM of CO was 14.7, 2.4, and 16.8 ppm among smokers, ENDS users, and dual users (p < .001). Conclusions: ENDS users did not differ in nicotine and had lower exposure to a lung carcinogen and a cardiovascular toxicant than smokers or dual users. Dual users and smokers did not differ in biomarker levels. Results should be used to inform tribal regulations and to educate the AI community on ENDS.

Community-Based Study Recruitment of American Indian Cigarette Smokers and Electronic Cigarette Users.

Data on the effectiveness of strategies for the recruitment of American Indians (AIs) into research is needed. This study describes and compares methods for identifying and recruiting AI tobacco users into a pilot study. Community-based strategies were used to recruit smokers (n = 35), e-cigarette users (n = 28), and dual users (n = 32) of AI descent. Recruitment was considered proactive if study staff contacted the individual at a pow wow, health fair, or vape shop and participation on-site or reactive if the individual contacted the study staff and participation occurred later. Screened, eligible, participated and costs and time spent were compared with Chi square tests. To understand AI descent, the relationship between number of AI grandparents and AI blood quantum was examined. Number of participants screened via the proactive strategy was similar to the reactive strategy (n = 84 vs. n = 82; p-value = 0.8766). A significantly greater proportion of individuals screened via the proactive than the reactive strategy were eligible (77 vs. 50%; p-value = 0.0002) and participated (75 vs. 39%; p-value = < 0.0001). Per participant cost and time estimated for the proactive strategy was $89 and 87 min compared to $79 and 56 min for the reactive strategy. Proportion at least half AI blood quantum was 32, 33, and 70% among those with 2, 3, and 4 AI grandparents, respectively (p = 0.0017). Proactive strategies resulted in two-thirds of the sample, but required more resources than reactive strategies. Overall, we found both strategies were feasible and resulted in the ability to reach sample goals. Lastly, number of AI biological grandparents may be a good, non-invasive indicator of AI blood quantum.