Total Results: 16
Carroll, Dana Mowls; Tan, Andy; Differding, Mackenzie; Wackowski, Olivia A.; Rubenstein, Dana; Hatsukami, Dorothy K.; Noonan, Devon; McClernon, F. Joseph
2025.
Beliefs regarding nicotine replacement therapy among rural residing people who smoke: a step towards promoting uptake.
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Objective: Rural areas in the United States (U.S.) have a higher smoking prevalence than urban areas. This disparity is influenced by lower odds of quitting smoking in rural versus urban areas, and lower use of evidence-based treatments, including nicotine replacement therapy (NRT). To inform strategies for promoting NRT, this qualitative study elicited and ranked NRT beliefs among rural people who smoke cigarettes. Methods: In 2023, we conducted an online, semi-qualitative, elicitation survey with US rural residing adults (ages 21+) who smoke (n = 52), using open-ended questions to probe about: perceived advantages/disadvantages of using NRT to quit smoking and facilitators/barriers towards using NRT. Responses were coded based on belief themes and the frequencies of these themes were tabulated. Results: Leading perceived advantages of NRT for a quit attempt included help with cravings (42 %), making quitting easier (23 %) and easing withdrawal (17 %), while perceived disadvantages were concerns about becoming addicted to another product (29 %), high cost (23 %), side effects (19 %), and being ineffective (13–17 %). Leading perceived barriers to NRT use referred to high cost (52 %), negative taste (19 %), not enough nicotine (13 %), and lack of access (11 %), while leading perceived facilitators to use were free or lower cost (54 %) and better access/availability (13 %) and flavors/taste (13 %). Conclusions: Boosting NRT use among rural communities could be achieved by (1) adopting approaches to enhance the affordability and accessibility of NRT, (2) rectifying NRT misperceptions, and (3) offering guidance on the proper use of NRT and managing side effects.
Hackworth, Emily E; Carroll, Dana Mowls; Donny, Eric C; Denlinger-Apte, Rachel L; Hatsukami, Dorothy
2025.
Policy support and potential black-market use in response to a reduced nicotine standard: responses following a 12-week open-label clinical trial.
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A reduced nicotine standard (RNS) could be one of the most significant tobacco control policies in history. The recent proposed rule issued by the U.S. Food and Drug Administration for an RNS is based on evidence showing that very low nicotine content (VLNC) cigarettes potentially decrease smoking rates, resulting in a substantial decline in smoking-related disease.1 One potential concern of an RNS is the potential to contribute to a pervasive black market for normal nicotine content (NNC) cigarettes.2 Furthermore, support for an RNS is likely to be discussed as part of the rationale for (or against) its implementation. To address these concerns, the present study describes the intent to seek black-market cigarettes and policy support for an RNS among adults after non-blinded assignment to VLNC cigarettes in a 12-week clinical trial.
Participants were randomised to receive either VLNC or NNC cigarettes and also had access to non-combusted tobacco/nicotine products (eg, e-cigarettes, oral tobacco) in an experimental marketplace (methods reported elsewhere).3 The full demographics of the VLNC arm of …
Said, Ridwan J.; Carroll, Dana Mowls; Luo, Xianghua; Hu, Jiayi; Cao, Qing; Tessier, Katelyn M.; Bittencourt, Lorna; Hatsukami, Dorothy K.
2025.
Secondary analysis of a randomized clinical trial of very low nicotine cigarettes: Outcomes across social and demographic groups.
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Hackworth, Emily E; Carroll, Dana Mowls; Donny, Eric C; Denlinger-Apte, Rachel L; Hatsukami, Dorothy
2025.
Policy support and potential black-market use in response to a reduced nicotine standard: responses following a 12-week open-label clinical trial.
Abstract
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Full Citation
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Google
A reduced nicotine standard (RNS) could be one of the most significant tobacco control policies in history. The recent proposed rule issued by the U.S. Food and Drug Administration for an RNS is based on evidence showing that very low nicotine content (VLNC) cigarettes potentially decrease smoking rates, resulting in a substantial decline in smoking-related disease.1 One potential concern of an RNS is the potential to contribute to a pervasive black market for normal nicotine content (NNC) cigarettes.2 Furthermore, support for an RNS is likely to be discussed as part of the rationale for (or against) its implementation. To address these concerns, the present study describes the intent to seek black-market cigarettes and policy support for an RNS among adults after non-blinded assignment to VLNC cigarettes in a 12-week clinical trial.
Participants were randomised to receive either VLNC or NNC cigarettes and also had access to non-combusted tobacco/nicotine products (eg, e-cigarettes, oral tobacco) in an experimental marketplace (methods reported elsewhere).3 The full demographics of the VLNC arm of …
Said, Ridwan J.; Carroll, Dana Mowls; Luo, Xianghua; Hu, Jiayi; Cao, Qing; Tessier, Katelyn M.; Bittencourt, Lorna; Hatsukami, Dorothy K.
2025.
Secondary analysis of a randomized clinical trial of very low nicotine cigarettes: Outcomes across social and demographic groups.
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Hackworth, Emily E; Carroll, Dana Mowls; Donny, Eric C; Denlinger-Apte, Rachel L; Hatsukami, Dorothy
2025.
Policy support and potential black-market use in response to a reduced nicotine standard: responses following a 12-week open-label clinical trial.
Abstract
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Full Citation
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Google
A reduced nicotine standard (RNS) could be one of the most significant tobacco control policies in history. The recent proposed rule issued by the U.S. Food and Drug Administration for an RNS is based on evidence showing that very low nicotine content (VLNC) cigarettes potentially decrease smoking rates, resulting in a substantial decline in smoking-related disease.1 One potential concern of an RNS is the potential to contribute to a pervasive black market for normal nicotine content (NNC) cigarettes.2 Furthermore, support for an RNS is likely to be discussed as part of the rationale for (or against) its implementation. To address these concerns, the present study describes the intent to seek black-market cigarettes and policy support for an RNS among adults after non-blinded assignment to VLNC cigarettes in a 12-week clinical trial.
Participants were randomised to receive either VLNC or NNC cigarettes and also had access to non-combusted tobacco/nicotine products (eg, e-cigarettes, oral tobacco) in an experimental marketplace (methods reported elsewhere).3 The full demographics of the VLNC arm of …
Said, Ridwan J.; Carroll, Dana Mowls; Luo, Xianghua; Hu, Jiayi; Cao, Qing; Tessier, Katelyn M.; Bittencourt, Lorna; Hatsukami, Dorothy K.
2025.
Secondary analysis of a randomized clinical trial of very low nicotine cigarettes: Outcomes across social and demographic groups.
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Carroll, Dana Mowls; Jennings, Dylan; Stately, Antony; Kamath, Amika; Tessier, Katelyn M; Cotoc, Crina; Egbert, Andrew; Begnaud, Abbie; Businelle, Michael; Hatsukami, Dorothy; Pickner, Wyatt; Dana, Dr; Carroll, Mowls
2024.
Pilot randomised controlled trial of a culturally aligned smoking cessation app for American Indian persons.
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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.
Eaton, Anne A; Hatsukami, Dorothy K; Stepanov, Irina; Shields, Peter G; Carroll, Dana Mowls
2024.
Estimating the causal effect of filter ventilation levels in cigarettes on past 30-day smoking.
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Eaton, Anne A; Hatsukami, Dorothy K; Stepanov, Irina; Shields, Peter G; Carroll, Dana Mowls
2024.
Estimating the causal effect of filter ventilation levels in cigarettes on past 30-day smoking.
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Eaton, Anne A; Hatsukami, Dorothy K; Stepanov, Irina; Shields, Peter G; Carroll, Dana Mowls
2024.
Estimating the causal effect of filter ventilation levels in cigarettes on past 30-day smoking.
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Noonan, Devon; Frisbee, Suzanne; Bittencourt, Lorna; Rubenstein, Dana; McClernon, F. Joseph; Carroll, Dana Mowls
2024.
Rural-urban differences in smoking quit ratios and cessation-related factors: Results from a nationally representative sample.
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Purpose: There are significant rural/urban disparities that exist in cancer and chronic disease morbidity and mortality, many of which are attributed to increased tobacco use prevalence in rural populations compared to urban. Understanding differences in rural and urban tobacco use patterns is key to developing targeted interventions. Methods: Using nationally representative data from Wave 5 of the Population Assessment of Tobacco Use and Health (PATH), we examined weighted frequencies and conducted multivariable logistic regression to examine the use of cessation supports in people who currently smoke with a quit attempt in the last 12 months (recent attempters) by rural and urban status and geographic region. Our second objective was to examine lifetime quitting in rural versus urban people who smoke and by geographic region. Results: Rural people who recently attempted to quit were less likely to use any FDA-approved cessation aids, less likely to use Nicoctine Replacement Therapy (NRT), and less likely to be exposed to a home smoking ban in the adjusted analysis. The adjusted odds of quitting were lower in the rural Northeast, Midwest, and South compared to the urban regions. Conclusions: Findings from this data can serve to inform the development of targeted interventions for rural communities.
Hatsukami, Dorothy K.; Jensen, Joni A.; Carroll, Dana Mowls; Luo, Xianghua; Strayer, Lori G.; Cao, Qing; Hecht, Stephen S.; Murphy, Sharon E.; Carmella, Steven G.; Denlinger-Apte, Rachel L.; Colby, Suzanne; Strasser, Andrew A.; McClernon, F. Joseph; Tidey, Jennifer; Benowitz, Neal L.; Donny, Eric C.
2024.
Reduced nicotine in cigarettes in a marketplace with alternative nicotine systems: randomized clinical trial.
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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.
Rubenstein, Dana; Denlinger-Apte, Rachel L; Ross, Jennifer Cornacchione; Carroll, Dana Mowls; McClernon, F Joseph
2023.
Older age is associated with greater misperception of the relative health risk of e-cigarettes and cigarettes among US adults who smoke.
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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.
Carroll, Dana Mowls; Tessier, Katelyn; Luo, Xianghua; Stepanov, Irina S; Shields, Peter G; O'connor, Richard; Rees, Vaughan W; Cummings, Michael; Bickel, Warren; Hatsukami, Dorothy; Dana, Dr; Carroll, Mowls
2023.
Switching to cigarette brand variants with different filter ventilation levels: a descriptive analysis.
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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.
Cooley, Chelsea; Pickner, Wyatt; Widome, Rachel; Jennings, Dylan; Stately, Antony; Cole, Ashley B; Cash, Jennifer; Dorr, Casey; Hernadez, Carol; Hatsukami, Dorothy; Businelle, Michael; Carroll, Dana Mowls
2023.
American Indian perspectives on culturally aligning a digital smoking cessation resource.
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Introduction: Innovative smoking cessation approaches that overcome barriers such as traveling
Total Results: 16