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BackgroundSuicide is an important public health concern in the United States and around the world. There has been significant work examining machine learning approaches to identify and predict intentional self-harm and suicide using existing data sets. With recent advances in computing, deep learning applications in health care are gaining momentum. ObjectiveThis study aimed to leverage the information in clinical notes using deep neural networks (DNNs) to (1) improve the identification of patients treated for intentional self-harm and (2) predict future self-harm events. MethodsWe extracted clinical text notes from electronic health records (EHRs) of 835 patients with International Classification of Diseases (ICD) codes for intentional self-harm and 1670 matched controls who never had any intentional self-harm ICD codes. The data were divided into training and holdout test sets. We tested a number of algorithms on clinical notes associated with the intentional self-harm codes using the training set, including several traditional bag-of-words–based models and 2 DNN models: a convolutional neural network (CNN) and a long short-term memory model. We also evaluated the predictive performance of the DNNs on a subset of patients who had clinical notes 1 to 6 months before the first intentional self-harm event. Finally, we evaluated the impact of a pretrained model using Word2vec (W2V) on performance. ResultsThe area under the receiver operating characteristic curve (AUC) for the CNN on the phenotyping task, that is, the detection of intentional self-harm in clinical notes concurrent with the events was 0.999, with an F1 score of 0.985. In the predictive task, the CNN achieved the highest performance with an AUC of 0.882 and an F1 score of 0.769. Although pretraining with W2V shortened the DNN training time, it did not improve performance. ConclusionsThe strong performance on the first task, namely, phenotyping based on clinical notes, suggests that such models could be used effectively for surveillance of intentional self-harm in clinical text in an EHR. The modest performance on the predictive task notwithstanding, the results using DNN models on clinical text alone are competitive with other reports in the literature using risk factors from structured EHR data.

Background: Cigarette smoking has major detrimental effects on oral health. Tobacco interventions in dental settings are effective, but rarely delivered. The American Dental Hygienists Association recommends that oral health providers: Ask patients about tobacco use, Advise quitting tobacco use, and Refer to state quitlines (Ask-Advise-Refer; AAR). While AAR connects patients to counseling, it does not directly connect patients to medication. Nicotine replacement therapy sampling (NRTS) is an empirically supported intervention to provide starter packs of nicotine replacement therapy (NRT) to people who smoke. NRTS combined with AAR could be an effective tobacco treatment intervention for dental settings., Methods: This manuscript describes the study protocol for the Free Samples for Health (FreSH) study, a group randomized clinical trial testing the effectiveness of NRTS + AAR vs. AAR alone on long-term smoking abstinence. Fifty dental practices in the Midwest and Northeast nodes of the National Dental Practice-Based Research Network are randomly assigned to provide AAR and either a 2-week supply of 14-mg nicotine patches and 4-mg nicotine lozenges (NRTS condition) or an electric toothbrush (ET condition). Approximately 1,200 patients who currently smoke-regardless of interest in quitting- are recruited during dental visits. Participants complete a baseline survey in-person, then after visit, 1-, 3-, and 6-month follow-up surveys remotely. The primary outcome is carbon monoxide-confirmed 7-day point prevalence abstinence from combustible tobacco measured at 6 months post-enrollment. Secondary outcomes include: 24-h intentional quit attempts, change in cigarettes smoked per day, NRT utilization, attitudes toward NRT, intention to use NRT, and intention to quit smoking. A key informant process evaluation and cost effectiveness analysis will provide information for future implementation of NRTS., Discussion: This is the first clinical trial to assess the effectiveness of NRTS on promoting smoking cessation in dental settings. If effective, this treatment could be implemented to increase the provision of smoking cessation interventions in dental settings to provide an additional treatment access point for people who smoke., Trial Registration: Registered at ClincalTrials.gov (NCT05627596) on 11/25/2022., (© 2024. The Author(s).)

Background: To address enduring age-related tobacco disparities, it is critical to promote cessation treatment among older adults (aged 65+ years). Digital health platforms offer opportunities for wide dissemination of evidence-based behavioral cessation support. However, existing digital cessation treatments are not tailored to unique aging-related needs and preferences, resulting in low uptake. Detailed information is needed about how to best adapt these treatments for this age group., Objective: We aimed to collect detailed, hypothesis-generating information about expectations and preferences for cessation digital treatment among older adults who smoke cigarettes., Methods: Semistructured interviews were conducted with adults aged 65+ years currently smoking or who had quit within the past month. Interviews included open-ended questions regarding prior experiences with digital health platforms and expectations and preferences for cessation treatment via various modalities (app-delivered, texting-based, or videoconferencing counseling). Interviews also elicited questions regarding digital modalities that integrated social components (app-delivered social forums and group videoconferencing counseling). Using an iterative, team-based approach, the thematic analysis identified meaningful themes. Interviews were supplemented with quantitative measures assessing sociodemographics, digital literacy, and physical health symptoms., Results: Participants (12/20, 60% men; 15/20, 75% White; 4/20, 20% Black or African American; 1/20, 5% Asian) were currently smoking (17/20, 85%) or had recently quit (3/20, 15%). Thematic analysis identified 3 meaningful themes across all digital modalities: convenience, accessibility, and personalization. Expected benefits of digital platforms included convenient treatment access, without reliance on transportation. Participants preferred treatments to be personalized and deliver content or strategies beyond standard education. Most (17/20, 85%) were unfamiliar with cessation apps but found them appealing given the potential for offering a novel quitting strategy. App ease of use (eg, easy navigation) was preferred. Half (10/20, 50%) would try a texting-based intervention, with many preferring texting with a counselor rather than automated messaging. Most (17/20, 85%) would use videoconferencing and expected this modality to deliver better quality counseling than via telephone. Expected videoconferencing challenges included looking presentable onscreen, technological difficulties, and privacy or security. Videoconferencing was regarded as the most personalized digital treatment, yet benefits unique to app-delivered and texting-based treatments included anonymity and access to treatment 24/7. Participants expected integrating social components into digital treatment to be useful for quit success and social connection, yet were concerned about possible interpersonal challenges., Conclusions: Because a long history of quit attempts and familiarity with standard quitting advice is common among older adults who smoke cigarettes, digital platforms might offer appealing and novel strategies for cessation that are accessible and convenient. Overall, this population was open to trying digital cessation treatments and would prefer that these platforms prioritize ease of use and personalized content. These findings challenge the bias that older adults are uninterested or unwilling to engage with digital treatments for behavioral health., (©Margaret C Fahey, Mathew J Carpenter, Riley O'Neal, Kinsey Pebley, Melissa R Schick, Emily Ware, Benjamin A Toll, Jennifer Dahne. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 28.08.2024.)

Background: Cannabis use is prevalent among cancer patients and survivors and may provide some therapeutic benefits for this population. However, benefits may be attenuated when cannabis is co-used with tobacco, which is associated with more severe tobacco and cannabis use and adverse outcomes in noncancer populations. We compared cannabis use, primary mode of use, and therapeutic and/or nontherapeutic use among 3 groups of patients and survivors based on cigarette smoking status., Methods: Survey data was collected from patients and survivors with cancer (n = 1732) at 2 US National Cancer Institute-designated cancer centers in states with varying cannabis regulatory policy. Prevalence of cannabis use (prior to diagnosis, after diagnosis, before treatment, after treatment), primary mode of use, and therapeutic and/or nontherapeutic use were assessed by cigarette smoking status (current, former, never) within and across centers using weighted bivariate analyses and multivariable logistic regression, controlling for demographic and clinical variables., Results: Current cigarette use was associated with greater rates of cannabis use prior to diagnosis, after diagnosis, during treatment, and after treatment within each center (all P < .001) and in pooled analyses across centers (all P < .001). Primary mode of use, knowledge of cannabis products, and therapeutic and/or nontherapeutic use also statistically differed by tobacco status and study site., Conclusions: Results illustrate the importance of conducting assessments for both tobacco and cannabis use among cancer patients during and after cancer treatment, regardless of the cannabis regulatory environment. Given previous data indicating harms from co-use and continued tobacco use during cancer treatment, this issue introduces new priorities for cancer care delivery and research., (© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objectives: Cigarette smoking negatively affects oral health. Nicotine replacement therapies (NRT; e.g. nicotine patch or lozenge) and brief interventions (e.g. Ask-Advise-Refer; AAR) can improve cessation outcomes but are underutilized. NRT sampling (NRTS) increases NRT utilization by providing patients with samples of NRT as part of routine healthcare. Ask-Advise-Refer is a brief intervention where practitioners: ask patients about tobacco use, advise those using tobacco to quit and refer to the state quit line. The objective of this qualitative study was to explore dental care practitioners' and patients' attitudes and experiences regarding tobacco cessation treatment and perceptions of two brief intervention models, assessed separately: NRTS and AAR., Methods: Twenty-four dental care practitioners and nine patients, recruited through the National Dental Practice-Based Research Network, participated in semi-structured telephone interviews. Interviews assessed experiences with tobacco use intervention and attitudes towards NRTS and AAR. Thematic analysis identified emergent themes related to feasibility and acceptability of NRTS and AAR., Results: Practitioners varied on how they address tobacco use, from systematically to idiosyncratically. Some practitioners recommend NRT; few had prescribed it. Practitioners had favourable attitudes towards AAR and NRTS, with most believing that both interventions would be acceptable and feasible to implement. Concerns regarding AAR were time and patient resistance to discussing tobacco use. Concerns regarding NRTS were patient resistance to using NRT, side effects or medication interactions, and capacity to provide follow-up. Patients reported that oral health practitioners generally ask about tobacco use but do not provide interventions. Patients were open to discussing their tobacco use with practitioners and had favourable attitudes about NRTS., Conclusions: This formative work suggests that NRTS and AAR may be feasible to implement in dental care settings. Future studies are needed to assess the effectiveness and implementation potential of NRTS in dental care settings., (© 2023 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Introduction: To improve the feasibility of remote biochemical verification of smoking status, our team developed "COast," a mobile app integrated with REDCap that allows a research participant to complete self-report research assessments and provide a breath sample via the iCOQuit Smokerlyzer for the purposes of carbon monoxide (CO) testing. The aims of the present study were to examine (1) the validity of remote CO data capture using COast as compared to gold-standard approaches (salivary cotinine, stand-alone CO monitor) and (2) the feasibility of remote CO data capture using COast as applied to both daily and weekly CO collection schedules., Methods: Participants (N = 143, 59% Female), including recently quit (n = 36) and current (n = 107) smokers, completed a baseline video session to capture validity data, and then were randomized to daily or weekly CO monitoring for a period of 1 month., Results: Balancing both sensitivity and specificity, optimal cut-points for defining abstinence using the COast system were <4 parts per million (ppm) with salivary cotinine as the referent (Sensitivity = 100%, Specificity = 92.8%) and <8 ppm with the stand-alone CO monitor as the referent (Sensitivity = 100%, Specificity = 88.9%). Compliance across groups with CO monitoring was high with average compliance of 74% for the daily group and 84% for the weekly group. Self-reported feasibility and acceptability of using the system were strong., Conclusions: Pairing the iCOQuit with REDCap via the COast app was both valid and feasible among a sample of adults who smoke cigarettes enrolled remotely. This integration may help to improve the rigor of decentralized smoking cessation trials., Implications: With increasing prevalence of decentralized trial designs, innovative methods are needed to remotely capture biomarkers. Methods that leverage existing widely available research data capture platforms may be particularly useful for promoting adoption. The COast app, which integrates a Bluetooth-enabled CO monitor with REDCap, is a fitting, valid, and feasible solution to remotely biochemically verify smoking status., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Depression is prevalent among individuals who smoke cigarettes and increases risk for relapse. A previous clinical trial suggests that Goal2Quit, a behavioral activation-based smoking cessation mobile app, effectively increases smoking abstinence and reduces depressive symptoms. Objective: Secondary analyses were conducted on these trial data to identify predictors of success in depression-specific digitalized cessation interventions. Methods: Adult who smoked cigarettes (age = 38.4 ± 10.3, 53% women) were randomized to either use Goal2Quit for 12 weeks ( N  = 103), paired with a 2-week sample of nicotine replacement therapy (patch and lozenge) or to a Treatment-As-Usual (TAU) control ( N  = 47). The least absolute shrinkage and selection operator was utilized to identify a subset of baseline variables predicting either smoking or depression intervention outcomes. The retained predictors were then fitted via linear regression models to determine relations to each intervention outcome. Results: Relative to TAU, only individuals who spent significant time using Goal2Quit (56 ± 46 min) were more likely to reduce cigarette use by at least 50% after 12 weeks, whereas those who spent minimal time using Goal2Quit (10 ± 2 min) did not exhibit significant changes. An interaction between educational attainment and treatment group revealed that, as compared to TAU, only app users with an educational degree beyond high school exhibited significant reductions in depression. Conclusions: The findings highlight the importance of tailoring depression-specific digital cessation interventions to individuals' unique engagement needs and educational level. This study provides a potential methodological template for future research aimed at personalizing technology-based treatments for cigarette users with depressive symptoms.

Purpose: Body image distress (BID) among head and neck cancer (HNC) survivors is a debilitating toxicity associated with depression, anxiety, stigma, and poor quality of life. BRIGHT (Building a Renewed ImaGe after Head & neck cancer Treatment) is a brief cognitive behavioral therapy (CBT) that reduces BID for these patients. This study examines the mechanism underlying BRIGHT., Methods: In this randomized clinical trial, HNC survivors with clinically significant BID were randomized to receive five weekly psychologist-led video tele-CBT sessions (BRIGHT) or dose-and delivery matched survivorship education (attention control [AC]). Body image coping strategies, the hypothesized mediators, were assessed using the Body Image Coping Skills Inventory (BICSI). HNC-related BID was measured with the Inventory to Measure and Assess imaGe disturbancE-Head and Neck (IMAGE-HN). Causal mediation analyses were used to estimate the mediated effects of changes in BICSI scores on changes in IMAGE-HN scores., Results: Among 44 HNC survivors with BID allocated to BRIGHT (n = 20) or AC (n = 24), mediation analyses showed that BRIGHT decreased avoidant body image coping (mean change in BICSI-Avoidance scale score) from baseline to 1-month post-intervention relative to AC (p = 0.039). Decreases in BICSI-Avoidance scores from baseline to 1-month resulted in decreases in IMAGE-HN scores from baseline to 3 months (p = 0.009). The effect of BRIGHT on IMAGE-HN scores at 3 months was partially mediated by a decrease in BICSI-Avoidance scores (p = 0.039)., Conclusions: This randomized trial provides preliminary evidence that BRIGHT reduces BID among HNC survivors by decreasing avoidant body image coping. Further research is necessary to confirm these results and enhance the development of interventions targeting relevant pathways to reduce BID among HNC survivors., Trial Registration: ClinicalTrials.gov identifier NCT03831100 ., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Cigarette smoking remains the leading cause of preventable disease and death in the United States. Primary care offers an ideal setting to reach adults who smoke cigarettes and improve uptake of evidence-based cessation treatment. Although U.S. Preventive Services Task Force Guidelines recommend the 5As model (Ask, Advise, Assess, Assist, Arrange) in primary care, there are many barriers to its implementation. Automated, comprehensive, and proactive tools are needed to overcome barriers. Our team developed and preliminarily evaluated a proactive electronic visit (e-visit) delivered via the Electronic Health Record patient portal to facilitate evidence-based smoking cessation treatment uptake in primary care, with promising initial feasibility and efficacy. This paper describes the rationale, design, and protocol for an ongoing Hybrid Type I effectiveness-implementation trial that will simultaneously assess effectiveness of the e-visit intervention for smoking cessation as well as implementation potential across diverse primary care settings., Methods: The primary aim of this remote five-year study is to examine the effectiveness of the e-visit intervention vs. treatment as usual (TAU) for smoking cessation via a clinic-randomized clinical trial. Adults who smoke cigarettes are recruited across 18 primary care clinics. Clinics are stratified based on their number of primary care providers and randomized 2:1 to either e-visit or TAU. An initial baseline e-visit gathers information about patient smoking history and motivation to quit, and a clinical decision support algorithm determines the best evidence-based cessation treatment to prescribe. E-visit recommendations are evaluated by a patient's own provider, and a one-month follow-up e-visit assesses cessation progress. Main outcomes include: (1) cessation treatment utilization (medication, psychosocial cessation counseling), (2) reduction in cigarettes per day, and (3) biochemically verified 7-day point prevalence abstinence (PPA) at six-months. We hypothesize that patients randomized to the e-visit condition will have better cessation outcomes (vs. TAU). A secondary aim evaluates e-visit implementation potential at patient, provider, and organizational levels using a mixed-methods approach. Implementation outcomes include acceptability, adoption, fidelity, implementation cost, penetration, and sustainability., Discussion: This asynchronous, proactive e-visit intervention could provide substantial benefits for patients, providers, and primary care practices and has potential to widely improve reach of evidence-based cessation treatment., Trial Registration: NCT05493254., (© 2023. The Author(s).)

Background: Depression is common among adults who smoke cigarettes. Existing depression-specific cessation interventions have limited reach and are unlikely to improve smoking prevalence rates among this large subgroup of smokers., Objective: This study aimed to determine whether a mobile app-based intervention tailored for depression paired with a mailed sample of nicotine replacement therapy (NRT) is efficacious for treating depression and promoting smoking cessation., Methods: A 2-arm nationwide remote randomized clinical trial was conducted in the United States. Adults (N=150) with elevated depressive symptoms (Patient Health Questionnaire-8≥10) who smoked were enrolled. The mobile app ("Goal2Quit") provided behavioral strategies for treating depression and quitting smoking based on Behavioral Activation Treatment for Depression. Goal2Quit participants also received a 2-week sample of combination NRT. Treatment as usual participants received a self-help booklet for quitting smoking that was not tailored for depression. Primary end points included Goal2Quit usability, change in depression (Beck Depression Inventory-II) across 12 weeks, and smoking cessation including reduction in cigarettes per day, incidence of 24-hour quit attempts, floating abstinence, and 7-day point prevalence abstinence (PPA)., Results: In total, 150 participants were enrolled between June 25, 2020, and February 23, 2022, of which 80 were female (53.3%) and the mean age was 38.4 (SD 10.3) years. At baseline, participants on average reported moderate depressive symptoms and smoked a mean of 14.7 (SD 7.5) cigarettes per day. Goal2Quit usability was strong with a mean usability rating on the System Usability Scale of 78.5 (SD 16.9), with 70% scoring above the ≥68 cutoff for above-average usability. Retention data for app use were generally strong immediately following trial enrollment and declined in subsequent weeks. Those who received Goal2Quit and the NRT sample reported lower mean depressive symptoms over the trial duration as compared to treatment as usual (difference of mean 3.72, SE 1.37 points less; P=.01). Across time points, all cessation outcomes favored Goal2Quit. Regarding abstinence, Goal2Quit participants reported significantly higher rates of 7-day PPA at weeks 4 (11% vs 0%; P=.02), 8 (7-day PPA: 12% vs 0%; P=.02), and 12 (16% vs 2%; P=.02)., Conclusions: A mobile app intervention tailored for depression paired with a sample of NRT was effective for depression treatment and smoking cessation. Findings support the utility of this intervention approach for addressing the currently unmet public health treatment need for tailored, scalable depression-specific cessation treatments., Trial Registration: ClinicalTrials.gov NCT03837379; https://clinicaltrials.gov/ct2/show/NCT03837379., (©Jennifer Dahne, Amy E Wahlquist, Jacob Kustanowitz, Noelle Natale, Margaret Fahey, Evan M Graboyes, Vanessa A Diaz, Matthew J Carpenter. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 01.11.2023.)

Purpose: Body image distress (BID) among head and neck cancer (HNC) survivors leads to depression, social isolation, stigma, and poor quality of life. BRIGHT (Building a Renewed ImaGe after Head and neck cancer Treatment) is a brief, tailored cognitive behavioral therapy (CBT) that reduces HNC-related BID. This trial examines the effect of BRIGHT on psychosocial outcomes among HNC survivors with BID., Methods: In this pilot randomized trial, HNC survivors with clinically significant BID were randomized to 5 weekly psychologist-led tele-CBT sessions (BRIGHT) or dose and delivery-matched survivorship education (attention control [AC]). Secondary psychosocial outcomes were assessed using validated patient-reported outcomes at baseline and 1 and 3-month post-intervention., Results: Among 44 HNC survivors with BID, BRIGHT resulted in a greater reduction in depression relative to AC (mean model-based 1-month difference in Δ PROMIS SF v1.0-Depression 8a score, -3.4; 90% CI, -6.4 to -0.4; 3-month difference, -4.3; 90% CI, -7.8 to -0.8). BRIGHT also decreased shame and stigma relative to AC (mean model-based 3-month difference in Δ Shame and Stigma Scale score, -9.7; 90% CI, -15.2 to -4.2) and social isolation (mean model-based 3-month difference in Δ PROMIS SF v2.0 Social Isolation 8a score, -2.9; 90% CI, -5.8 to -0.1)., Conclusions: In this planned secondary analysis of a pilot RCT, BRIGHT improved a broad array of psychosocial outcomes among HNC survivors with BID., Trial Registration: ClinicalTrials.gov identifier: NCT03831100 ., Implications for Cancer Survivors: These promising preliminary data suggest the need for a large efficacy trial evaluating the effect of BRIGHT on psychosocial outcomes among HNC survivors with BID., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: As summarised in the most recent Cochrane review, the few clinical trials on e-cigarettes are largely focused on smoking cessation. We aimed to determine the naturalistic uptake, use, and impact of e-cigarettes among adults who may or may not want to stop smoking., Methods: In this naturalistic, randomised, controlled clinical trial, adult smokers, across the motivational spectrum and with minimal history of e-cigarette use, were recruited online from the general community within 11 cities across the USA. Participants were randomly assigned (2:1) to either receive either a free 4-week supply of flavoured, tank-style e-cigarette, or not. E-cigarette group participants received a battery and device with up to 30 pre-filled tanks, offered among five flavours, with minimal instructions on use. The study's primary purpose was to descriptively assess naturalistic uptake and usage of the e-cigarette, and to secondarily assess its impact on smoking behavior. The latter, assessed through six months of follow-up, included: a) self-reported 7-day point prevalence abstinence, b) incidence of quit attempts, and c) smoking reduction. This trial is registered at ClinicalTrials.gov, NCT03453385., Findings: Between 5/2018 and 3/2022, 638 adult smokers were enrolled and randomly assigned (427 in the e-cigarette group and 211 in the no-product control group). Uptake of e-cigarettes was robust: approximately 70% of participants used the product, with average usage exceeding 4 days per week during the initial 30 days. Based on an intent-to-treat approach where missing data is imputed as smoking, almost all behavioral outcomes favored the e-cigarette group relative to no-product control, including point prevalence abstinence at six months (Odds Ratio [OR] = 1.8; 95% Confidence Interval [CI] = 1.0-3.1), cumulative incidence of 24-hr quit attempts (OR = 1.5; 95% CI = 1.0-2.2), and having reduced smoking by at least 50% since baseline (OR = 1.8; 95% CI = 1.2-2.7). Results were similar under an alternative imputation., Interpretation: Complementing cessation-focused trials, results suggest that unguided e-cigarette use also leads to smoking cessation, allaying the notion that causal effects of e-cigarettes on cessation are not reflective of real-world scenario of self-determined use. For smokers who may not be able to quit using existing pharmacologic approaches, e-cigarettes may be considered to achive that purpose., Funding: National Cancer Institute., Competing Interests: KMC has served as a paid expert witness in litigation filed against the tobacco industry. KMG has provided consultation to Jazz Pharmaceuticals and has received research funding from Aelis Farma. MLG has served as a member of the Scientific Advisory Board to Johnson & Johnson; he has also consulted with both the World Health Organization and Campaign for Tobacco Free Kids on toxicity of tobacco products and tobacco control products; MLG is also a Member of the IASLC Tobacco Control and Smoking Cessation Committee; and a leadership role with the American Association for Cancer Research. JD is a co-owner of Behavioral Activation Tech LLC, a small business that develops digital interventions for behavioral health treatment. E-cigarette products (tanks and liquids) were purchased directly from NJoy; no study support provided from industry. All other authors declare no competing interests., (© 2023 The Author(s).)

Introduction: NicoBloc is a viscous fluid applied to the cigarette filter designed to block tar and nicotine. This novel and understudied smoking cessation device presents a nonpharmacological means for smokers to gradually reduce nicotine and tar content while continuing to smoke their preferred brand of cigarette. This pilot study aimed to assess the feasibility, acceptability, and initial efficacy of NicoBloc as compared with nicotine replacement therapy (nicotine lozenge)., Methods: A community sample of predominately Black smokers (N = 45; 66.7% Black) were randomized to receive NicoBloc or nicotine lozenge. Both groups engaged in 4 weeks of smoking cessation therapy followed by 2 months of independent usage with monthly check-ins to assess medication adherence. The intervention lasted 12 weeks, and the study concluded with a 1-month postintervention follow-up visit (week 16)., Results: NicoBloc was comparable with nicotine lozenge in smoking reduction, feasibility, symptom adverse effects, and reported acceptability at week 16. Participants in the lozenge group endorsed higher treatment satisfaction ratings during the intervention and lower cigarette dependence. Adherence to NicoBloc was superior throughout the study., Conclusion: NicoBloc was feasible and acceptable to community smokers. NicoBloc presents a unique, nonpharmacological intervention. Future research is needed to examine whether this intervention may be most effective in subpopulations where pharmacological approaches are restricted or in combination with established pharmacological methods such as nicotine replacement therapy., Competing Interests: The authors report no conflicts of interest., (Copyright © 2023 American Society of Addiction Medicine.)

Older adults are a high priority population for smoking cessation. This study observed the influence of older age on the relationship between quitting predictors and cessation. Secondary analysis was conducted of a primary care trial of adults who smoke cigarettes randomized to standard advice to quit or advice plus 2 week supply of nicotine replacement therapy. Logistic regressions assessed interactions of age (<60 vs. ≥ 60 years) by predictors in relation to quit attempts and 6-month cessation controlling for treatment. Predicting quit attempts, there was an interaction of age by motivation ( p = .025) and trend of age by nicotine dependence ( p = .057). Predicting 6-month cessation, an interaction of age by motivation was observed ( p = .020) and a trend of age by dependence ( p = .067). For those with high nicotine dependence, older adults had less successful outcomes compared to younger counterparts. Yet among participants unmotivated to quit, older adults had more successful outcomes than those younger.

Purpose: Cannabis use among patients with cancer is common, yet data are limited regarding use patterns, reasons for use, and degree of benefit, which represents an unmet need in cancer care delivery. This need is salient in states without legal cannabis programs, where perceptions and behavior among providers and patients may be affected., Methods: A cross-sectional survey of patients with cancer and survivors at the Hollings Cancer Center at the Medical University of South Carolina (no legal cannabis marketplace in SC) was completed as part of the NCI Cannabis Supplement. Patients (ages 18 +) were recruited using probability sampling from patient lists (N = 7749 sampled; N = 1036 completers). Weight-adjusted Chi-square tests compared demographics and cancer details among patients using cannabis since diagnosis versus those not using cannabis, while weighted descriptives are presented for cannabis use prevalence, consumption, symptom management, and legalization beliefs., Results: Weighted prevalence of cannabis use since diagnosis was 26%, while current cannabis use was 15%. The most common reasons for cannabis use after diagnosis were difficulty sleeping (50%), pain (46%), and mood changes and stress, anxiety, or depression (45%). Symptom improvement was endorsed for pain (57%), stress/anxiety/depression (64%), difficulty sleeping (64%), and loss of appetite (40%)., Conclusions: Among patients with cancer and survivors at a NCI-designated cancer center within SC, a state without legal access to medical cannabis, prevalence rates, and reasons for cannabis use are consistent with emerging literature in oncology populations. These findings have implications for care delivery, and work is needed to inform recommendations for providers and patients., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Introduction: As clinical trials adopt remote methodologies, there is need to optimize efficiency of remote enrollment. Within a remote clinical trial, we aim to (1) assess if sociodemographic factors differ among those consenting via mail vs. technology-based procedures (e-consent), (2) determine if, among those consenting via mail, a small unconditional monetary reward ($5) increases likelihood of subsequent enrollment, (3) economically evaluate additional cost per additional participant enrolled with $5 reward., Methods: In the parent nationwide randomized clinical trial of adult smokers ( N = 638), participants could enroll via mail or e-consent. Logistic regression models assessed relationships between sociodemographics and enrollment via mail (vs e-consent). Mailed consent packets were randomized (1:4) to include $5 unconditional reward or not, and logistic regression modeling examined impact of reward on subsequent enrollment, allowing for a randomized study within a study. Incremental cost-effectiveness ratio analysis estimated additional cost per additional participant enrolled with $5 incentive., Results: Older age, less education, lower income, and female sex predicted enrolling via mail vs e-consent ( p < .05's). In adjusted model, older age (AOR = 1.02, p = .016) and less education (AOR = 2.23, p < .001) remained predictive of mail enrollment. The $5 incentive (vs none) increased enrollment rate by 9% (AOR = 1.64, p = .007), with estimated cost of additional $59 per additional participant enrolled., Conclusions: As e-consent methods become more common, they have potential to reach many individuals but with perhaps diminished inclusion across all sociodemographic groups. Provision of an unconditional monetary incentive is possibly a cost-effective mechanism to increase recruitment efficiency for studies employing mail-based consenting procedures., Competing Interests: The authors have no conflicts of interest to declare., (© The Author(s) 2023.)

Background: Pharmacotherapies remain a central focus of successful tobacco control, but uptake remains very low., Objective: To estimate the cost effectiveness of a primary care nicotine replacement therapy (NRT) sampling intervention., Design: A Markov cohort simulation model was constructed to conduct cost-effectiveness analyses. Clinical trial results were used to initialize the Markov model. All other model parameters were derived from the literature. The study was conducted over a lifetime horizon, from the payers' budgetary perspective., Participants: Smokers with a primary care visit., Intervention: Medication sampling, which provided short, starter packets of NRT (nicotine patch and lozenge) to smokers in the primary care setting., Main Measures: Lifetime healthcare expenditures, quality-adjusted life years, and life years., Key Results: Medication sampling was the dominant strategy compared to standard care. Our intervention cost $75, yielding a discounted lifetime savings of $1065 in healthcare expenditures, and increased both discounted quality-adjusted life years and discounted life years by 0.01. One-way sensitivity analyses showed that medication sampling remained dominant in plausible ranges except when it failed to increase cessation relative to standard care. Probabilistic sensitivity analyses confirmed that medication sampling was dominant in 94.1% of the simulated cases, with an implementation cost of $74 (95% CI $73-$76) and discounted lifetime savings in health expenditures of $1061 (- $1106 to - $1,017), increasing quality-adjusted life years by 0.008 (0.0085-0.0093) and life years by 0.008 (0.0081-0.0089)., Conclusion: Medication sampling, an easily implementable, scalable and low-cost intervention to encourage smoking cessation, is cost saving and improves quality of life., (© 2022. The Author(s) under exclusive licence to Society of General Internal Medicine.)

Background: Most smokers with chronic obstructive pulmonary disease (COPD) have not yet been diagnosed, a statistic that has remained unchanged for over two decades. A dual-focused telehealth intervention that promotes smoking cessation, while also facilitating COPD screening, could help address national priorities to improve the diagnosis, prevention, treatment, and management of COPD. The purpose of this study was to preliminarily evaluate an integrated asynchronous smoking cessation and COPD screening e-visit (electronic visit) that could be delivered proactively to adult smokers at risk for COPD, who are treated within primary care., Objective: The aims of this study were (1) to examine e-visit feasibility and acceptability, particularly as compared to in-lab diagnostic pulmonary function testing (PFT), and (2) to examine the efficacy of smoking cessation e-visits relative to treatment as usual (TAU), all within primary care., Methods: In a randomized clinical trial, 125 primary care patients who smoke were randomized 2:1 to receive either proactive e-visits or TAU. Participants randomized to the e-visit condition were screened for COPD symptoms via the COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE). Those with scores ≥2 were invited to complete both home spirometry and in-lab PFTs, in addition to two smoking cessation e-visits. Smoking cessation e-visits assessed smoking history and motivation to quit and included completion of an algorithm to determine the best Food and Drug Administration-approved cessation medication to prescribe. Primary outcomes included measures related to (1) e-visit acceptability, feasibility, and treatment metrics; (2) smoking cessation outcomes (cessation medication use, 24-hour quit attempts, smoking reduction ≥50%, self-reported abstinence, and biochemically confirmed abstinence); and (3) COPD screening outcomes., Results: Of 85 participants assigned to the e-visits, 64 (75.3%) were invited to complete home spirometry and in-lab PFTs based on CAPTURE. Among those eligible for spirometry, 76.6% (49/64) completed home spirometry, and 35.9% (23/64) completed in-lab PFTs. At 1 month, all cessation outcomes favored the e-visit, with a significant effect for cessation medication use (odds ratio [OR]=3.22). At 3 months, all cessation outcomes except for 24-hour quit attempts favored the e-visit, with significant effects for cessation medication use (OR=3.96) and smoking reduction (OR=3.09)., Conclusions: A proactive, asynchronous e-visit for smoking cessation and COPD screening may offer a feasible, efficacious approach for broad interventions within primary care., Trial Registration: ClinicalTrials.gov NCT04155073; https://clinicaltrials.gov/ct2/show/NCT04155073., (©Jennifer Dahne, Marty S Player, Charlie Strange, Matthew J Carpenter, Dee W Ford, Kathryn King, Sarah Miller, Ryan Kruis, Elizabeth Hawes, Johanna E Hidalgo, Vanessa A Diaz. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 30.08.2022.)

Background: This study examined whether exposure to misinformation found on Twitter about e-cigarette harms leads to inaccurate knowledge and misperceptions of harms of e-cigarette use among cigarette smokers., Methods: We conducted an online randomized controlled experiment in November 2019 among an online sample of 2400 adult US and UK cigarette smokers who did not currently use e-cigarettes. Participants viewed four tweets in one of four conditions: 1) e-cigarettes are as or more harmful than smoking, 2) e-cigarettes are completely harmless, 3) e-cigarette harms are uncertain and 4) control (physical activity). Outcomes were knowledge about e-cigarettes and harm perceptions of e-cigarette use for five diseases. We conducted multiple logistic and linear regressions to analyze the effect of experimental conditions on outcomes, controlling for baseline knowledge and perceived harms., Findings: Participants in the 'as or more harmful' condition (vs. control group) had higher odds of accurate knowledge about e-cigarettes containing toxic chemicals ( p  < 0.001), not containing only water vapor (p < 0.001) and containing formaldehyde ( p  < 0.001). However, these participants had lower odds of accurate knowledge that e-cigarettes did not contain tar ( p  < 0.001) and contained fewer toxins than cigarettes ( p  < 0.001). Exposure to 'as or more harmful' tweets also increased harm perceptions for five diseases (all p  < 0.001), with the greatest effect observed for lung cancer (β = 0.313, p  < 0.001). This effect was greater among UK participants for all diseases., Interpretation: Brief exposure to misinformation on Twitter reduced accurate knowledge of the presence of tar and the level of toxins compared with smoking and increased harm perceptions of e-cigarette use., Competing Interests: Declaration of conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article. OE is currently an employee of AstraZeneca but was not employed there during the design of the research or the time when the study was fielded., (© The Author(s) 2022.)

Background: Despite efforts towards gender parity and some improvement over time, gender bias in peer review remains a pervasive issue. We examined gender representation and homophily in the peer review process for Drug and Alcohol Dependence (DAD)., Methods: We extracted data for papers submitted to DAD between 2004 and 2019, inclusive. Inferred gender was assigned to handling editors and reviewers using the NamSor gender inference Application Programming Interface (API)., Results: Men and women handling editors were approximately equally likely to invite women reviewers over time, with only a few exceptions. Over time, 47.1% of editors were women, and 42.6% of review invitations were sent to women. Men were largely consistent over time in their likelihood of accepting a review invitation, while the likelihood of women accepting a review invitation was more variable over time. Gender differences in rates of accepting a review invitation were minimal; however, as women approached half of all invited reviewers in recent years, there has been a greater trend for women, relative to men, to decline review invitations. Evidence of homophily on the part of reviewers accepting invitations was minimal, but in certain years, a tendency to accept review invitations at higher rates from editors of the same gender was observed., Discussion: Given the benefits of diversity in scientific advancement, these results underline the importance of continuing efforts to increase gender diversity among editors and in reviewer pools, and the need for reviewers to be mindful of their own reviewing practices., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: Nicotine vaping among youth has increased, warranting concern from tobacco control proponents. Many youth who vape indicate interest in quitting; however, few empirically supported vaping cessation interventions exist. This pilot feasibility study adapted an established behavioral intervention, contingency management (CM), delivered via telehealth to promote vaping cessation among young adults., Methods: Participants (N = 27; ages 17-21) vaping nicotine regularly were recruited via social media and digital advertisements from across the US (June 2020-January 2021). Participants were randomized at approximately 4:1 to CM or Monitoring control (22:5). CM was delivered through DynamiCare Health's smartphone app for 4 weeks, in which financial incentives were delivered contingent on abstinent cotinine samples after the quit day until the end of treatment (EOT; Days 7-28; 10 expected submissions). Control participants earned incentives for submitting cotinine, regardless of abstinence. Feasibility, acceptability, and abstinence was collected throughout treatment, at EOT, and at 1-month follow-up., Results: The majority of enrolled participants completed treatment (Monitoring: 5/5; CM: 20/22), and intervention components were rated favorably overall (> 80%). CM participants submitted 112/220 (55%) abstinent cotinine samples throughout the quit attempt, while the Monitoring group submitted 4/50 (8%) negative samples. There were no differences in abstinence between groups at EOT or follow-up., Conclusion: This pilot study of a telehealth-based youth vaping cessation intervention demonstrated preliminary feasibility and acceptability. These results suggest that CM for young adult vaping cessation, delivered remotely, is a promising direction for future work and fully powered trials are warranted to assess intervention efficacy., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: Information and misinformation on the internet about e-cigarette harms may increase smokers' misperceptions of e-cigarettes. There is limited research on smokers' engagement with information and misinformation about e-cigarettes on social media., Objective: This study assessed smokers' likelihood to engage with-defined as replying, retweeting, liking, and sharing-tweets that contain information and misinformation and uncertainty about the harms of e-cigarettes., Methods: We conducted a web-based randomized controlled trial among 2400 UK and US adult smokers who did not vape in the past 30 days. Participants were randomly assigned to view four tweets in one of four conditions: (1) e-cigarettes are as harmful or more harmful than smoking, (2) e-cigarettes are completely harmless, (3) uncertainty about e-cigarette harms, or (4) control (physical activity). The outcome measure was participants' likelihood of engaging with tweets, which comprised the sum of whether they would reply, retweet, like, and share each tweet. We fitted Poisson regression models to predict the likelihood of engagement with tweets among 974 Twitter users and 1287 non-Twitter social media users, adjusting for covariates and stratified by UK and US participants., Results: Among Twitter users, participants were more likely to engage with tweets in condition 1 (e-cigarettes are as harmful or more harmful than smoking) than in condition 2 (e-cigarettes are completely harmless). Among other social media users, participants were more likely to likely to engage with tweets in condition 1 than in conditions 2 and 3 (e-cigarettes are completely harmless and uncertainty about e-cigarette harms)., Conclusions: Tweets stating information and misinformation that e-cigarettes were as harmful or more harmful than smoking regular cigarettes may receive higher engagement than tweets indicating e-cigarettes were completely harmless., Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 16082420; https://doi.org/10.1186/ISRCTN16082420., (©Jessica Liu, Caroline Wright, Philippa Williams, Olga Elizarova, Jennifer Dahne, Jiang Bian, Yunpeng Zhao, Andy S L Tan. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 21.12.2021.)

There is a gap in knowledge on the affective mechanisms underlying effects of exposure to health misinformation. This study aimed to understand whether discrete emotional responses and perceived relative harm of e-cigarettes versus smoking mediate the effect of exposure to tweets about the harms of e-cigarettes on Twitter and intention to purchase e-cigarettes among adult smokers. We conducted a web-based experiment in November 2019 among 2400 adult smokers who were randomly assigned to view one of four conditions of tweets containing different levels of misinformation. We fitted mediation models using structural equation modeling and bootstrap procedures to assess the indirect effects of exposure to tweets through perceived relative harm of e-cigarettes and six discrete emotions. Our findings support that exposure to tweets about harms of e-cigarettes influence intention to purchase e-cigarettes through perceived relative harm, discrete emotional responses, and serially through emotional responses and perceived relative harm. Feeling worried, hopeful, and happy mediated the effects of condition on intention to purchase e-cigarettes. Feeling scared, worried, angry, and hopeful mediated the effects serially through perceived relative harm. Affective responses and perceived relative harm following exposure to misinformation about e-cigarette harm may mediate the relationship with intention to purchase e-cigarettes among adult smokers.

Objectives: To assess the effect of exposure to misinformation about e-cigarette harms found on Twitter on adult current smokers' intention to quit smoking cigarettes, intention to purchase e-cigarettes and perceived relative harm of e-cigarettes compared with regular cigarettes., Setting: An online randomised controlled experiment conducted in November 2019 among USA and UK current smokers., Participants: 2400 adult current smokers aged ≥18 years who were not current e-cigarette users recruited from an online panel. Participants' were randomised in a 1:1:1:1 ratio using a least-fill randomiser function., Interventions: Viewing 4 tweets in random order within one of four conditions: (1) e-cigarettes are just as or more harmful than smoking, (2) e-cigarettes are completely harmless, (3) e-cigarette harms are uncertain, and (4) a control condition of tweets about physical activity., Primary Outcomes Measures: Self-reported post-test intention to quit smoking cigarettes, intention to purchase e-cigarettes, and perceived relative harm of e-cigarettes compared with smoking., Results: Among US and UK participants, after controlling for baseline measures of the outcome, exposure to tweets that e-cigarettes are as or more harmful than smoking versus control was associated with lower post-test intention to purchase e-cigarettes (β=-0.339, 95% CI -0.487 to -0.191, p<0.001) and increased post-test perceived relative harm of e-cigarettes (β=0.341, 95% CI 0.273 to 0.410, p<0.001). Among US smokers, exposure to tweets that e-cigarettes are completely harmless was associated with higher post-test intention to purchase e-cigarettes (β=0.229, 95% CI 0.002 to 0.456, p=0.048) and lower post-test perceived relative harm of e-cigarettes (β=-0.154, 95% CI -0.258 to -0.050, p=0.004)., Conclusions: US and UK adult current smokers may be deterred from considering using e-cigarettes after brief exposure to tweets that e-cigarettes were just as or more harmful than smoking. Conversely, US adult current smokers may be encouraged to use e-cigarettes after exposure to tweets that e-cigarettes are completely harmless. These findings suggest that misinformation about e-cigarette harms may influence some adult smokers' decisions to consider using e-cigarettes., Trial Registration Number: ISRCTN16082420., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Background: Internet cognitive behavioural therapy (iCBT) is a viable delivery format of CBT for depression. However, iCBT programmes include training in a wide array of cognitive and behavioural skills via different delivery methods, and it remains unclear which of these components are more efficacious and for whom., Methods: We did a systematic review and individual participant data component network meta-analysis (cNMA) of iCBT trials for depression. We searched PubMed, PsycINFO, Embase, and the Cochrane Library for randomised controlled trials (RCTs) published from database inception to Jan 1, 2019, that compared any form of iCBT against another or a control condition in the acute treatment of adults (aged ≥18 years) with depression. Studies with inpatients or patients with bipolar depression were excluded. We sought individual participant data from the original authors. When these data were unavailable, we used aggregate data. Two independent researchers identified the included components. The primary outcome was depression severity, expressed as incremental mean difference (iMD) in the Patient Health Questionnaire-9 (PHQ-9) scores when a component is added to a treatment. We developed a web app that estimates relative efficacies between any two combinations of components, given baseline patient characteristics. This study is registered in PROSPERO, CRD42018104683., Findings: We identified 76 RCTs, including 48 trials contributing individual participant data (11 704 participants) and 28 trials with aggregate data (6474 participants). The participants' weighted mean age was 42·0 years and 12 406 (71%) of 17 521 reported were women. There was suggestive evidence that behavioural activation might be beneficial (iMD -1·83 [95% credible interval (CrI) -2·90 to -0·80]) and that relaxation might be harmful (1·20 [95% CrI 0·17 to 2·27]). Baseline severity emerged as the strongest prognostic factor for endpoint depression. Combining human and automated encouragement reduced dropouts from treatment (incremental odds ratio, 0·32 [95% CrI 0·13 to 0·93]). The risk of bias was low for the randomisation process, missing outcome data, or selection of reported results in most of the included studies, uncertain for deviation from intended interventions, and high for measurement of outcomes. There was moderate to high heterogeneity among the studies and their components., Interpretation: The individual patient data cNMA revealed potentially helpful, less helpful, or harmful components and delivery formats for iCBT packages. iCBT packages aiming to be effective and efficient might choose to include beneficial components and exclude ones that are potentially detrimental. Our web app can facilitate shared decision making by therapist and patient in choosing their preferred iCBT package., Funding: Japan Society for the Promotion of Science., Competing Interests: Declaration of interests TAF reports grants from Japan Society for Promotion of Science, during the conduct of the study; grants and personal fees from Mitsubishi-Tanabe, personal fees from MSD, grants and personal fees from Shionogi, outside the submitted work; a patent 2018-177688 concerning smartphone CBT apps pending; and an intellectual properties for Kokoro-app licensed to Tanabe-Mitsubishi. AC reports personal fees from Italian Network for Paediatric Trials and CARIPLO Foundation; and grants and personal fees from Angelini Pharma, outside the submitted work. EGO reports personal fees from Angelini Pharma, outside the submitted work. PCa reports personal fees from Osmond Foundation and Sandoz, outside the submitted work. JD is co-owner of Behavioral Activation Tech LLC, a small business that develops and evaluates mobile app-based treatments for depression and co-occurring disorders. DDE has served as a consultant to or on the scientific advisory boards of Sanofi, Novartis, Minddistrict, Lantern, Schoen Kliniken, Ideamed, German health insurance companies (BARMER, Techniker Krankenkasse), and a number of federal chambers for psychotherapy; is a stakeholder of the Institute for health training online (GET.ON), which aims to implement scientific findings related to digital health interventions into routine care. NRF is an employee of AbleTo. JPK reports grants and personal fees from Servier; personal fees from Beltz, Elsevier, Hogrefe, and Springer, outside the submitted work; funding for clinical trials (German Federal Ministry of Health and Servier); payments for presentations on internet interventions (Servier); and payments for workshops and books (Beltz, Elsevier, Hogrefe, and Springer) on psychotherapy for chronic depression and on psychiatric emergencies. BM is an employee of GAIA AG. DCM reports personal fees from Apple, Pear Therapeutics, and Otsuka Pharmaceuticals and has an equity interest in Adaptive Health, outside the submitted work. JMM is supported by a Wellcome Trust Grant (104908/Z/14/Z). SN is an employee of GET.ON Institut. DR is an employee of SilverCloud Health. LBS is an employee of Influents Innovations. PZ reports grants and non-financial support from Techniker Krankenkasse (German public health insurance company), outside the submitted work. CK reports personal fees from Oberbergklinik and Servier; and grants and non-financial support from Techniker Krankenkasse, outside the submitted work. MH reports grants and non-financial support from Techniker Krankenkasse, outside the submitted work. All other authors declare no competing interests., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Introduction: Medication sampling is a clinically useful tool to engage smokers in the quitting process. Whether varenicline is suitable for sampling purposes is unclear. The purpose of this study was to examine the feasibility, uptake, and preliminary outcomes of varenicline sampling., Methods: Smokers (N = 99), both motivated to quit and not, were recruited and randomized to varenicline sampling versus not, with 12 week follow-up. The intervention consisted of mailing one-time samples of varenicline (lasting 2-4 wks), with minimally suggestive guidance on use., Results: Uptake of varenicline was strong, at 2 weeks (54% any use, 66% daily use) and 4 weeks (38%, 46%), with 58% of medication users seeking additional medication. Most users followed conventional titration patterns, self-titrating from 0.5 mg to 2 mg. Relative to control, varenicline sampling increased motivation (p = 0.006) and confidence to quit (p = 0.02), and decreased cigarette smoking (p = 0.02). Smokers receiving varenicline samples were significantly more likely to achieve 50% reduction in cigarettes per day (CPD), both immediately following the sampling exercise (Adjusted Odds Ratio [AOR] = 4.12; 95% CI: 1.39 to 12.17) and at final follow-up (AOR = 4.50; 95% CI: 1.56 to 13.01). Though cessation outcomes were not statistically significant, there was a 1.5 to 3-fold increase in quit attempts and abstinence from varenicline sampling throughout follow-up. These outcomes were comparable among smokers motivated to quit and not., Conclusions: Unguided, user-driven sampling of varenicline sampling is a concrete behavioral exercise that is feasible to do and seems to suggest clinical utility. Sampling is a pragmatic clinical approach to engage more smokers in quitting., Implications: Use of evidence-based pharmacotherapies for smoking cessation is low. Medication sampling is a pragmatic behavioral exercise that allows smokers to experience the benefits of using them, while promoting positive downstream effects towards quitting. While previous studies have shown that nicotine replacement therapy (NRT) sampling is viable and effective, whether this extends to varenicline is unclear. Results from this trial demonstrate that varenicline sampling is feasible, safe, and suggestive of clinically important steps toward quitting, deserving of a larger trial., Clinical Trial Registration: NCT #03742154., (© The Author(s) 2020. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved.For permissions, please e-mail: journals.permissions@oup.com.)

Introduction: Newly available, smartphone-enabled carbon monoxide (CO) monitors are lower in cost than traditional stand-alone monitors and represent a marked advancement for smoking research. New products are promising, but data are needed to compare breath CO readings between smartphone-enabled and stand-alone monitors. The purpose of this study was to (1) determine the agreement between the mobile iCO (Bedfont Scientific Ltd) with two other monitors from the same manufacturer (Micro+ pro and Micro+ basic) and (2) determine optimal, monitor-specific, cotinine-confirmed abstinence cutoff values., Methods: Adult (≥18) smokers (n = 26) and nonsmokers (n = 21) provided three breath CO samples (using three different monitors) in each of 10 sessions, and urine cotinine was measured for gold standard determination of abstinence. CO comparisons (N = 437) were analyzed using regression-based Bland-Altman Analysis of Agreement; receiver operating characteristics curves were used to determine optimal abstinence cutoffs., Results: Bland-Altman analyses indicated that the iCO monitor provided higher CO results than both Micro+ monitors. Sensitivity and specificity analyses showed that the optimal CO cutoff for determining abstinence was <3 ppm for the Micro+ pro (88% sensitivity, 93% specificity) and Micro+ basic (83% sensitivity, 98% specificity), but was higher for the iCO (<6 ppm; 73% sensitivity, 100% specificity)., Conclusions: Relative to both Micro+ monitors, the smartphone-enabled iCO provided systematically higher CO values and required a higher cutoff to reliably determine smoking abstinence. This does not indicate that CO values obtained using the iCO are not valid; instead, these results suggest that monitor-specific abstinence cutoffs are needed to ensure accurate bioverification of smoking status., Implications: Results from this study indicate that CO values from the smartphone-enabled iCO should not be used interchangeably with the stand-alone Micro+ pro and Micro+ basic, particularly when lower CO values (<10 ppm) are critical (ie, determination of abstinence vs confirming smoking status for study inclusion). Optimal CO cutoffs recommended for determining abstinence on Micro+ and iCO monitors are at <3 and <6 ppm, respectively., (© The Author(s) 2020. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Best practice guidelines for smoking cessation treatment through primary care advise the 5As model. However, compliance with these guidelines is poor, leaving many smokers untreated. The purpose of this study was to develop and preliminarily evaluate an asynchronous smoking cessation electronic visit (e-visit) that could be delivered proactively through the electronic health record (EHR) to adult smokers treated within primary care. The goal of the e-visit is to automate 5As delivery to ensure that all smokers receive evidence-based cessation treatment. As such, the aims of this study were twofold: (1) to examine acceptability, feasibility, and treatment metrics associated with e-visit utilization and (2) to preliminarily examine efficacy relative to treatment as usual (TAU) within primary care. Methods: Participants ( n  = 51) were recruited from primary care practices between November 2018 and October 2019 and randomized 2:1 to receive either the smoking cessation e-visit or TAU. Participants completed assessments of cessation outcomes 1-month and 3-months postenrollment and e-visit analytics data were gathered from the EHR. Results: Self-report feedback from e-visit participants indicated satisfaction with the intervention and interest in using e-visits again in the future. Nearly all e-visits resulted in prescription of a U.S. Food and Drug Administration (FDA)-approved smoking cessation medication. In general, smoking cessation outcomes favored the e-visit condition at both 1 (odds ratios [ORs]: 2.10-5.39) and 3 months (ORs: 1.31-4.67). Conclusions: These results preliminarily indicate the feasibility, acceptability, and efficacy of this smoking cessation e-visit within primary care. Future studies should focus on larger scale examination of effectiveness and implementation across settings. The clinicaltrials.gov registration number for this trial is NCT04316260.

Introduction: The 5As model is a standard component of most guidelines for tobacco treatment. Unfortunately, provider adherence to this model is modest., Aims: Providing physicians with adjunctive tools to adhere to 5As guidelines may serve as a catalyst for brief advice delivery., Methods: This was a secondary data analysis of a cluster randomized clinical trial assessing the uptake and impact of free nicotine replacement therapy (NRT) sampling versus standard care in primary care. Patients reported receipt of separate elements of the 5As model, assessed one month following a baseline visit. Analyses compared patients who recalled receipt of brief advice among those who received NRT vs. standard care. Additional analyses examined demographic predictors of receiving brief advice., Results/findings: Medication sampling did not improve compliance with ask, advise, or assess. Receipt of "assistance" was significantly higher among NRT recipients (70%) ( p ≤ 0.0001). The NRT sampling group was more likely to have received all components ( p = 0.004). As age increased, being asked ( p = 0.006), advised ( p = 0.05), and assessed ( p = 0.003) decreased. Non-Whites reported higher rates of assessment ( p = 0.02)., Conclusions: Provision of NRT sampling increased provider compliance with some elements of the brief advice model, thus enhancing the impact of cessation advice within primary care., Trial Registration: This trial is registered with ClinicalTrials.gov NCT02096029., Competing Interests: Conflicts of Interest Drs. Carpenter and Toll have received consulting honoraria from Pfizer. Dr. Toll has additionally served as a paid expert witness in litigation filed against the tobacco industry. All other authors declare no conflict of interest.

Most tobacco-focused clinical trials are based on locally conducted studies that face significant challenges to implementation and successful execution. These challenges include the need for large, diverse, yet still representative study samples. This often means a protracted, costly, and inefficient recruitment process. Multisite clinical trials can overcome some of these hurdles but incur their own unique challenges. With recent advances in mobile health and digital technologies, there is now a promising alternative: Remote Trials. These trials are led and coordinated by a local investigative team, but are based remotely, within a given community, state, or even nation. The remote approach affords many of the benefits of multisite trials (more efficient recruitment of larger study samples) without the same barriers (cost, multisite management, and regulatory hurdles). The Coronavirus Disease 2019 (COVID-19) global health pandemic has resulted in rapid requirements to shift ongoing clinical trials to remote delivery and assessment platforms, making methods for the conduct of remote trials even more timely. The purpose of the present review is to provide an overview of available methods for the conduct of remote tobacco-focused clinical trials as well as illustrative examples of how these methods have been implemented across recently completed and ongoing tobacco studies. We focus on key aspects of the clinical trial pipeline including remote: (1) study recruitment and screening, (2) informed consent, (3) assessment, (4) biomarker collection, and (5) medication adherence monitoring. Implications With recent advances in mobile health and digital technologies, remote trials now offer a promising alternative to traditional in-person clinical trials. Remote trials afford expedient recruitment of large, demographically representative study samples, without undo burden to a research team. The present review provides an overview of available methods for the conduct of remote tobacco-focused clinical trials across key aspects of the clinical trial pipeline., (© The Author(s) 2020. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved.For permissions, please e-mail: journals.permissions@oup.com.)

The purpose of the present study was (1) to examine demographic differences between smokers who successfully quit (n = 1809), who relapsed (n = 6548), and who did not attempt to quit (n = 11 102) within the last year, and (2) to examine state-level tobacco policies/programs as predictors of quit success. Data were utilized from the 2014-2015 Tobacco Use Supplement to the Current Population Survey, which were paired with 2014 data on taxation, appropriations, and smoke-free air laws. As compared with smokers who relapsed, those who successfully quit were more likely to be white, married, more highly educated, of higher income, and heavier smokers. Compared with those who did not attempt to quit, those who attempted to quit, regardless of success, were younger and more likely to be Hispanic. State comprehensive smoke-free air laws and tobacco excise taxation significantly predicted quit success. Thus, expansions of these policies should be considered to promote successful quitting.

Background and Aims: Within the context of busy clinical settings, health-care providers need practical, evidence-based options to engage smokers in quitting. Sampling of nicotine replacement therapy [i.e. provision of nicotine replacement therapy (NRT starter kits)] is a brief, pragmatic strategy to address this need. We aimed to compare the effects of NRT sampling plus standard care (SC), relative to SC alone, provided by primary care providers during routine clinic visits., Design: Cluster-randomized clinical trial., Setting: Twenty-two primary care clinics in South Carolina, USA., Participants: Adult smokers [n = 1245; 61% female, mean age = 50.7, standard deviation (SD) = 13.5] both motivated and unmotivated to quit, seen during routine clinical visit. Interventions were provider-delivered SC (n = 652, 12 clinics) cessation advice or SC + a 2-week supply of both nicotine patch and lozenge, with minimal instructions on use (n = 593; 10 clinics)., Measurements: The primary outcome was 7-day point prevalence smoking abstinence at 6-month follow-up, using intent-to-treat. Additional outcomes included NRT use and quit attempts, assessed at 1, 3 and 6 months following baseline., Findings: Seven-day point prevalence abstinence rates were significantly higher in the NRT sampling group throughout follow-up, including at 6 months [12 versus 8%, odds ratio (OR) = 1.5, 95% confidence interval (CI) = 1.0-2.4]. NRT sampling increased prevalence of any use of NRT (65 versus 25%, OR = 5.8, 95% CI = 4.3-7.7), with higher prevalence of use at 6 months (25 versus 14%, OR = 2.0, 95% CI = 1.5-2.7). NRT sampling increased the rate of quit attempts in the initial month (24 versus 18%, OR = 1.5, 95% CI = 1.0-2.3) but had no significant effect on overall rate of quit attempts (48 versus 45%, OR = 1.2, 95% CI = 0.8-1.7)., Conclusion: Providing smokers with a free 2-week starter kit of nicotine replacement therapy increased quit attempts, use of stop smoking medications and smoking abstinence compared with standard care in a primary care setting., (© 2020 Society for the Study of Addiction.)

Cigarette smoking is increasingly concentrated among marginalized populations with limited access to evidence-based cessation treatment. This includes racial/ethnic minorities, lower income individuals, those with lower educational attainment, and residents of rural areas. To reach Healthy People 2020 objectives, successful cessation interventions must narrow these disparities. Nicotine replacement therapy (NRT) sampling is an easily translatable and scalable intervention that could enhance treatment access and thus narrow disparities. The present study examined individual-level demographic moderators of the impact of NRT sampling on cessation-related behaviors including: 1) use of a cessation medication, 2) making a 24-hour quit attempt, 3) floating abstinence, and 4) 7-day point prevalence abstinence at 6-months. Study participants included N = 1245 adult smokers enrolled in the Tobacco Intervention in Primary Care Treatment Opportunities for Providers (TIP TOP) study, a recently concluded large-scale clinical trial of NRT sampling relative to standard care within 22 primary care clinics across South Carolina. Generalized linear models examined individual-level demographic moderators of treatment effect. Results suggest that NRT sampling may be more effective among some of the most disadvantaged groups of smokers, including smokers with lower income and education, as well those who live in more rural areas. The effects of NRT sampling did not differ by race. In sum, NRT sampling is a low-cost, low-burden intervention that could be disseminated broadly to reach large numbers of smokers and potentially narrow cessation disparities., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background and Introduction:   Comprehensive monitoring and follow-up after traumatic injury is important for psychological recovery. However, scalable services to facilitate this are limited. Automated text message-based symptom self-monitoring (SSM) may be a feasible approach. This study examined its implementation and utility in identifying patients at risk for mental health difficulties after traumatic injury. Materials and Methods:   Five hundred two patients admitted to a Level I trauma center between June 20, 2016 and July 31, 2017 were offered enrollment in a text message-based SSM service. Patients who enrolled received daily text message prompts over 30 days and most participated in a mental health screening 30 days postbaseline. Results:   Approximately 67% of patients enrolled in the service; of these, 58% responded to the text messages, with an average response rate of 53%. Younger patients and those with elevated peritraumatic distress were more likely to enroll. Patients with higher levels of mental health stigma, who were White, or had been in a motor vehicle collision were more likely to enroll and respond to text messages once enrolled. Patients' daily ratings of distress detected clinically elevated 30-day mental health screens with high sensitivity (83%) and specificity (70%). Discussion and Conclusions:   Text message-based SSM can be implemented as a clinical service in Level I trauma centers, and patient participation may increase engagement in mental health follow-up. Further, it can inform the use of risk assessments in practice, which can be used to identify patients with poor psychological recovery who require additional screening.

Mobile technologies can be leveraged to meet the need for evidence-based psychological depression treatment via primary care. The purpose of the present study was to preliminarily examine the feasibility and efficacy of a self-help brief behavioral activation mobile application (app; "Moodivate") for depressive symptoms among adults treated via primary care. Participants (N = 52) were recruited from primary care practices between January and December 2017 and were randomized 2:2:1 to receive (a) Moodivate, (b) an active control cognitive-behavioral therapy-based mobile app ("MoodKit"), or (c) treatment as usual (TAU; no app). Participants completed assessments of depressive symptoms weekly for 8 weeks. App analytics data were captured to examine Moodivate feasibility (analytics unavailable for control app). Moodivate participants on average had 46.76 (SD = 30.10) app sessions throughout the trial duration, spent 3.50 (2.76) minutes using the app per session, and spent 120.76 (101.02) minutes using the app in total throughout the trial. Nearly 70% of Moodivate participants continued to use the app 1 month after trial enrollment and 50% at the end of the 8-week follow-up period. A generalized estimating equation model examining change in depressive symptoms over time by treatment condition indicated a significant interaction between time and treatment condition (χ 2 = 42.21, df = 14, p < .001). As compared to TAU, participants in both app conditions evidenced significant decreases in depressive symptoms over time, and these treatment gains were sustained across the trial period. These results preliminarily indicate feasibility of Moodivate as well as efficacy of both Moodivate and MoodKit for the treatment of depression among adults recruited via primary care. Future studies should focus on larger-scale examinations of treatment efficacy and effectiveness across primary care settings., (Copyright © 2019. Published by Elsevier Ltd.)

Background: To address the need for disseminable, evidence-based depression treatment options for Latinx adults with limited English proficiency (LEP), our team developed ¡Aptívate!, a Spanish-language Behavioral Activation self-help mobile application. Primary aims of this study were to: 1) examine feasibility and uptake of ¡Aptívate! among depressed Latinx adults with LEP and 2) preliminarily examine ¡Aptívate! efficacy for depression treatment., Methods: Participants (N = 42) with elevated depressive symptoms were randomized 2:1:1 to: 1) ¡Aptívate! (n = 22), 2) an active control Spanish-language app ("iCouch CBT"; n = 9), or 3) Treatment As Usual (i.e., no app; n = 11). Feasibility was assessed via self-reported app utilization and app analytics data. Depressive symptoms were assessed weekly for eight weeks via self report., Results: All ¡Aptívate! participants used the app at least once, 81.8% of participants used the app ≥8 times, and 36.4% of participants used the app ≥56 times. Weekly retention was strong: 72.7% and 50% of participants continued to use the app at one- and two-months post-enrollment, respectively. Generalized Estimating Equation models indicated a significant interaction between time and treatment, such that ¡Aptívate! participants reported significantly lower depressive symptoms over time than TAU. Depressive symptoms did not differ on average across time between the iCouch and TAU conditions, nor between iCouch and ¡Aptívate!., Limitations: Limitations include small sample size, limited follow-up, and lack of analytics data for the active control condition., Conclusions: With further research, ¡Aptívate! may offer a feasible, efficacious approach to extend the reach of evidence-based depression treatment for Latinx adults with LEP., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Treatment for depression is a core health disparity for Latino/as in the United States. U.S. Latino/as are most likely to report depressive symptoms to primary care physicians, who often have limited resources for providing evidence-based psychological depression treatment. This limited treatment accessibility is further compounded by additional treatment barriers, including stigma related to seeking mental health treatment and limited English proficiency. Mobile technologies, including smartphones and mobile applications (apps) delivered via smartphone, are promising for addressing this treatment need. Herein, we discuss the development of a Spanish-language brief behavioral activation mobile application, ¡Aptívate!, that was developed to disseminate depression-based psychological treatment via primary care to Spanish-speaking Latino/as. This article focuses on the description of (a) rationale for ¡Aptívate! treatment development, (b) treatment components, and (c) a clinical case example describing potential implementation in primary care. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Background: Cessation fatigue, a construct theorized to reflect exhaustion of coping resources due to quitting smoking, has been found to predict relapse. This study examines the association between cessation fatigue and duration of abstinence among 1397 adult former smokers who participated in the 2016 International Tobacco Control (ITC) Four Country Smoking and Vaping Wave 1 Survey (4CV). We hypothesized lower levels of cessation fatigue will be correlated with longer duration of abstinence., Method: Data for this cross-sectional study were collected in a web-based survey which recruited national samples from Australia, Canada, England, and United States. Former smokers were abstinent up to five years., Results: Lower cessation fatigue was associated with longer duration of smoking abstinence. Cessation fatigue was highest in former smokers that had been quit for up to six months, with lower cessation fatigue found in those quit for at least seven months and another drop-off in fatigue observed for those quit for at least two years., Conclusions: Cessation fatigue is highest soon after quitting smoking but declines over time for those who remain abstinent. Understanding the mechanisms by which cessation fatigue is related to abstinence could potentially offer insights into ways to help individuals sustain quitting., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Objective: Long-term abstinence can be undermined by cessation fatigue-an exhaustion of coping resources attributable to quitting smoking/staying quit. The current study examines the predictive validity of a Cessation Fatigue Scale (CFS; three subscales). Among current smokers, we hypothesized higher fatigue would predict longer latency to both quit initiation and achieving 7-day point prevalence abstinence (7-day PPA). Among recent quitters, we expected higher cessation fatigue would confer greater lapse/relapse risk. Lower rates of abstinence at 2-month follow-up were expected for those with higher fatigue., Method: Current smokers motivated to quit in the next month (n = 301) and recent quitters (n = 242) were assessed biweekly over the course of 2 months. Retention rates were high (>85%). Cox and logistic regression analyses tested hypotheses., Results: Among smokers, greater emotional exhaustion predicted longer delay to achieving 7-day PPA (HR = .53, 95% CI [.40, -.68], p < .001) and lower likelihood of 7-day PPA at 2-month follow-up (OR = .27, 95% CI [.16, -.46], p < .001), even after controlling for nicotine dependence and motivation to quit. Among recent quitters, emotional exhaustion progressively increased over the first 6 weeks since quit initiation. Elevated exhaustion was associated with greater lapse (HR = 1.65, 95% CI [1.06, 2.56], p < .05) and relapse (HR = 2.33, 95% CI [1.37, 3.97], p < .01) risk, and lower likelihood of 7-day PPA at 2-month follow-up (OR = .39, 95% CI [.16, .94], p < .05), even after controlling for nicotine withdrawal and motivation to quit., Conclusions: Cessation fatigue, as measured by the CFS's emotional exhaustion subscale, prospectively predicted important cessation milestones. Findings suggest that cessation fatigue is a novel process that undermines smoking cessation and a viable target for intervention. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Introduction: Evidence-based cessation methods including nicotine replacement therapy (NRT), non-NRT medications, quitlines, and behavioral treatments are underutilized by smokers attempting to quit. Although a number of studies have demonstrated a relationship between state-level tobacco policies (eg, taxation, appropriations) and cessation, whether such state-level factors influence likelihood of using an evidence-based treatment is unclear. Accordingly, the aims of the present study were: (1) to describe evidence-based cessation method utilization by state and (2) to examine the effect of state-level factors on cessation method utilization above and beyond individual-level predictors., Methods: Data were utilized from the 2010-2011 Tobacco Use Supplement to the Current Population Survey (TUS-CPS). Participants included 9232 smokers who reported a past-year quit attempt. Data on 11 state-level predictors were collated from national datasets. Analyses were based on: (1) descriptive characterization of quit method usage, (2) logistic regression models to determine state-level factors as predictors of quit method utilization, controlling for individual-level predictors, (3) cluster analyses grouping states with similar state-level factors, and (4) examination of cluster as a predictor of cessation method., Results: Tobacco control appropriations significantly predicted NRT, quitline, and behavioral treatment utilization. Additional state-level factors that demonstrated significant relationships included Medicaid coverage of non-NRT medications and behavioral treatment, tobacco tax rate, smoking prevalence, and percentage of population uninsured. State clustering significantly predicted quit method across all four methods., Conclusions: State-level factors influence the likelihood of residents utilizing evidence-based quit methods. Results are discussed in terms of implications for tobacco policy at the state level., Implications: Results from the present study highlight state tobacco control appropriations as a robust predictor of evidence-based cessation method utilization. Other significant state-level predictors of evidence-based cessation method utilization included Medicaid coverage of non-NRT medications and behavioral treatment, tobacco tax rate, smoking prevalence, and percentage of population uninsured. Moreover, state-level predictors clustered together to significantly predict evidence-based cessation method utilization. Thus, increasing tobacco control appropriations, extending health insurance coverage, maximizing revenue from tobacco taxation and tobacco settlements, and ultimately decreasing smoking prevalence are important targets for individual states to promote utilization of evidence-based cessation methods.