Cytisinicline for Vaping Cessation in Adults Using Nicotine E-Cigarettes: The ORCA-V1 Randomized Clinical Trial.

Importance: The prevalence of e-cigarette use among US adults, especially young adults, is rising. Many would like to quit vaping nicotine but are unable to do so. Cytisinicline, a plant-based alkaloid, targets nicotinic acetylcholine receptors, reduces nicotine dependence, and helps adults to stop smoking cigarettes. Cytisinicline may also help e-cigarette users to quit vaping. Objective: To determine the efficacy and safety of cytisinicline vs placebo to produce abstinence from e-cigarette use in adults seeking to quit vaping nicotine. Design, Setting, and Participants: This double-blind placebo-controlled randomized clinical trial compared 12 weeks of treatment with cytisinicline vs placebo, with follow-up to 16 weeks. It was conducted from July 2022 to February 2023 across 5 US clinical trial sites. A total of 160 adults who vaped nicotine daily, sought to quit, and did not currently smoke cigarettes were enrolled, and 131 (81.9%) completed the trial. Intervention: Participants were randomized (2:1) to cytisinicline, 3 mg, taken 3 times daily (n = 107) or placebo (n = 53) for 12 weeks. All participants received weekly behavioral support. Main Outcomes and Measures: Biochemically verified continuous e-cigarette abstinence during the last 4 weeks of treatment (weeks 9-12; primary outcome) and through 4 weeks posttreatment (weeks 9-16; secondary outcome). Missing outcomes were counted as nonabstinence. Results: Of 160 randomized participants (mean [SD] age, 33.6 [11.1] years; 83 [51.9%] female), 115 (71.9%) formerly smoked (≥100 lifetime cigarettes). Continuous e-cigarette abstinence in cytisinicline and placebo groups occurred in 34 of 107 participants (31.8%) vs 8 of 53 participants (15.1%) (odds ratio, 2.64; 95% CI, 1.06-7.10; P = .04) at end of treatment (weeks 9-12) and in 25 of 107 participants (23.4%) vs 7 of 53 participants (13.2%) during weeks 9 to 16 (odds ratio, 2.00; 95% CI, 0.82-5.32; P = .15). There was no evidence, based on nonsignificant interactions, that cytisinicline efficacy differed in subgroups defined by demographic characteristics, vaping pattern, e-cigarette dependence, or smoking history. Cytisinicline was well tolerated, with 4 participants (3.8%) discontinuing cytisinicline due to an adverse event. Conclusions and Relevance: In this randomized clinical trial, cytisinicline for 12 weeks, with behavioral support, demonstrated efficacy for cessation of e-cigarette use at end of treatment and was well tolerated by adults, offering a potential pharmacotherapy option for treating nicotine e-cigarette use in adults who seek to quit vaping. These results need confirmation in a larger trial with longer follow-up. Trial Registration: ClinicalTrials.gov Identifier: NCT05431387.

Adapting a Financial Incentives Intervention for Smoking Cessation with Alaska Native Families: Phase 1 Qualitative Research to Inform the Aniqsaaq (To Breathe) Study.

INTRODUCTION: Alaska Native and American Indian (ANAI) peoples in Alaska currently experience a disproportionate burden of morbidity and mortality from tobacco cigarette use. Financial incentives for smoking cessation are evidence-based, but a family-level incentive structure has not been evaluated. We used a community-based participatory research and qualitative approach to culturally adapt a smoking cessation intervention with ANAI families. METHODS: We conducted individual, semi-structured telephone interviews with 12 ANAI adults who smoke, 12 adult family members, and 13 Alaska Tribal Health System stakeholders statewide between November 2022-March 2023. Through content analysis, we explored intervention receptivity, incentive preferences, culturally aligned recruitment and intervention messaging, and future implementation needs. RESULTS: Participants were receptive to the intervention. Involving a family member was viewed as novel and aligned with ANAI cultural values of commitment to community and familial interdependence. Major themes included choosing a family member who is supportive and understanding, keeping materials positive and encouraging, and offering cash and non-cash incentives for family members to choose (e.g., fuel, groceries, activities). Participants indicated that messaging should emphasize family collaboration and that cessation resources and support tips should be provided. Stakeholders also reinforced that program materials should encourage the use of other existing evidence-based cessation therapies (e.g., nicotine replacement, counseling). CONCLUSIONS: Adaptations, grounded in ANAI cultural strengths were made to the intervention and recruitment materials based on participant feedback. Next steps include a beta-test for feasibility and a randomized controlled trial for efficacy. IMPLICATIONS: This is the first study to design and adapt a financial incentives intervention promoting smoking cessation among Alaska Native or American Indian (ANAI) peoples and the first to involve the family system. Feedback from this formative work was used to develop a meaningful family-level incentive structure with ANAI people who smoke and family members and ensure intervention messaging is supportive and culturally aligned. The results provide qualitative knowledge that can inform future family-based interventions with ANAI communities, including our planned randomized controlled trial of the intervention.

Smoking Cessation, or How to Avert Half a Billion Premature Deaths - Now.

An estimated 1.1 billion people currently smoke cigarettes,1 and 50 to 70% likely will die from tobacco-related causes.2 This translates to 550 to 770 million expected tobacco deaths among those who currently smoke. Many additional deaths will accrue in successive generations if the status quo continues. Of interest is the reversibility of the excess mortality risk of smoking. The meta-analysis by Cho et al.3 of four large national cohorts of nearly 1.5 million adults followed on average 14.8 years yielded 23.0 million person-years of observational data with over 120,000 deaths identified through linked death registries.

Predictors of Patient Engagement in Telehealth-Delivered Tobacco Cessation Treatment during the COVID-19 Pandemic.

Smoking causes one in three cancer deaths and may worsen COVID-19 outcomes. Telehealth tobacco cessation treatment is offered as a covered benefit for patients at the Stanford Cancer Center. We examined predictors of engagement during the COVID-19 pandemic. Data were abstracted from the Electronic Health Record between 3/17/20 (start of pandemic shelter-in-place) and 9/20/22, including patient tobacco use, demographics, and engagement in cessation treatment. Importance of quitting tobacco was obtained for a subset (53%). During the first 2.5 years of the pandemic, 2595 patients were identified as recently using tobacco, and 1571 patients were contacted (61%). Of the 1313 patients still using tobacco (40% women, mean age 59, 66% White, 13% Hispanic), 448 (34%) enrolled in treatment. Patient engagement was greater in pandemic year 1 (42%) than in year 2 (28%) and year 3 (19%). Women (41%) engaged more than men (30%). Patients aged 36-45 (39%), 46-55 (43%), 56-65 (37%), and 66-75 (33%) engaged more than patients aged 18-35 (18%) and >75 (21%). Hispanic/Latinx patients (42%) engaged more than non-Hispanic/Latinx patients (33%). Engagement was not statistically significantly related to patient race. Perceived importance of quitting tobacco was significantly lower in pandemic year 1 than year 2 or 3. Nearly one in three cancer patients engaged in telehealth cessation treatment during the COVID-19 pandemic. Engagement was greater earlier in the pandemic, among women, Hispanic/Latinx individuals, and patients aged 36 to 75. Sheltering-in-place, rather than greater perceived risk, may have facilitated patient engagement in tobacco cessation treatment.

Non-alcoholic beverage consumption among US adults who consume alcohol.

BACKGROUND AND AIMS: Non-alcoholic beverages (NABs) that mimic alcohol without inducing intoxication, such as non-alcoholic beers, non-alcoholic wines and spirit-free drinks, are increasing in popularity. It is unknown whether NABs help to mitigate or stimulate alcohol use. The present study aimed to describe NAB consumption practices among US adults consuming alcohol, characterize who is likely to consume NABs and examine whether NAB use influences desire for and perceived consumption of alcohol. DESIGN AND PARTICIPANTS: The survey study used data collected June-July 2023 from an on-line convenience sample. The first survey (n = 1906) assessed frequency of NAB consumption among US adults who consume alcohol. A second more detailed survey on use patterns was conducted with 466 respondents who reported past-year NAB consumption, of whom 153 (32.83%) screened positive on the CAGE questionnaire for alcohol use disorder (AUD). SETTING: This study took place in the United States. MEASUREMENTS: NAB consumption measures included type of NAB consumed, frequency, quantity, first consumption age, consumption reasons, consumption contexts and perceived effect on desire for and consumption of alcohol. Alcohol use measures included frequency, quantity and first consumption age. FINDINGS: Past-year NAB use was endorsed by 28.44% of respondents (61.70% ever used). Non-alcoholic liquor/'mocktails' were the most common NAB type consumed (83.69%). Compared with respondents without AUD, those who screened positive for AUD were significantly more likely to consume NABs in an effort to decrease or abstain from drinking alcohol [adjusted odds ratio (AOR) = 3.54, 95% confidence interval (CI) = 2.24-5.58] and 67.97% endorsed less alcohol consumption (3.23% endorsed more) due to their NAB use. NAB consumption frequency and quantity were significantly positively predicted by alcohol consumption frequency (AOR = 1.46, 95% CI = 1.17-1.83) and quantity (ß = 0.25, 95% CI = 0.15-0.35), respectively. CONCLUSION: Adults who consume alcohol and screen positive for alcohol use disorder report drinking non-alcoholic beverages as a harm reduction strategy.

Active Social Media Use and Health Indicators Among Sexual and Gender Minority Adults.

Purpose: Sexual and gender minority (SGM) individuals may receive social support through active use of social media (i.e., posting and interacting). This study examined associations between active social media use, social support, and health indicators in a large sample of SGM adults in the United States. Methods: Data were derived from the 2017 wave of The PRIDE Study, a national cohort study of SGM health. SGM-identified adults reporting social media use (N = 5995) completed measures of active social media use, social support, depressive symptoms, cigarette smoking, hazardous drinking, sleep, and physical activity. Regression models examined main and interactive effects of active social media use and social support on health indicators. Results: The sample reported a moderate level of active social media use (mean [M] = 3.2 [1.0], scale = 1-5) and relatively high social support (M = 16.7 [3.3], scale = 4-20); 31.8% reported moderate-to-severe depressive symptoms. Participants with greater active social media use were more likely to experience depressive symptoms (adjusted odds ratio [AOR] = 1.18, 95% confidence interval [CI] = 1.10-1.26), cigarette smoking (AOR = 1.11, 95% CI = 1.01-1.22), insufficient sleep (AOR = 1.13, 95% CI = 1.06-1.21), and physical inactivity (AOR = 1.09, 95% CI = 1.02-1.15) than those with less active social media use. Active social media use did not significantly interact with social support to predict any health indicators (p values >0.159). Conclusions: Among SGM adults, active social media use was associated with several negative health indicators. Active social media use may increase health risks, or SGM adults with poor health may actively use social media to maintain social connections. Moderate active social media use may be compatible with health.

Kratom availability in California vape shops.

Kratom products are derived from trees native to Southeast Asia and have dose-dependent stimulant and opioid-like effects. Despite being on the Drug Enforcement Administration "Drugs and Chemicals of Concern List," kratom is legal for sale in most US states. However, there are scarce data on its availability. The goal of this study was to examine kratom availability in vape shops across the state of California and assess shop compliance with a local kratom sales ban (enacted in 2016) in San Diego City. As part of a larger study about retail tobacco marketing near colleges, availability of kratom was assessed in summer 2019 in a random sample of 614 vape shops that was stratified to compare stores near (≤ 3 miles) and distant (>3 miles) from colleges. Logistic regression examined kratom availability as a function of store type (stores that sold vape products only vs. stores selling other tobacco), nearness to college, and tract-level demographics. Kratom was available in 62.4% of observed stores and more often in vape-and-smoke (81.1%) than vape-only shops (11.5%, AOR = 40.4, 95% CI = 23.3-74.1). Kratom availability did not differ by nearness to colleges. In San Diego City, 46.2% of observed stores (95% CI = 28.8-64.5) sold kratom products. Findings indicate that kratom was available in the majority of vape shops and most commonly in vape-and-smoke shops. Widespread availability in tobacco specialty shops suggests the need for research on dual use with tobacco, kratom advertising and cross-product promotion, and the potential of state and local tobacco retail licensing to prohibit sales.

Acceptability and Utility of a Smartphone App to Support Adolescent Mental Health (BeMe): Program Evaluation Study.

BACKGROUND: Adolescents face unprecedented mental health challenges, and technology has the opportunity to facilitate access and support digitally connected generations. The combination of digital tools and live human connection may hold particular promise for resonating with and flexibly supporting young people's mental health. OBJECTIVE: This study aimed to describe the BeMe app-based platform to support adolescents' mental health and well-being and to examine app engagement, usability, and satisfaction. METHODS: Adolescents in the United States, aged 13 to 20 years, were recruited via the web and enrolled between September 1 and October 31, 2022. App engagement, feature use, clinical functioning, and satisfaction with BeMe were examined for 30 days. BeMe provides content based on cognitive behavioral therapy, dialectical behavior therapy, motivational interviewing, and positive psychology; interactive activities; live text-based coaching; links to clinical services; and crisis support tools (digital and live). RESULTS: The average age of the sample (N=13,421) was 15.04 (SD 1.7) years, and 56.72% (7612/13,421) identified with she/her pronouns. For the subsample that completed the in-app assessments, the mean scores indicated concern for depression (8-item Patient Health Questionnaire mean 15.68/20, SD 5.9; n=239), anxiety (7-item Generalized Anxiety Disorder Questionnaire mean 13.37/17, SD 5.0; n=791), and poor well-being (World Health Organization-Five Well-being Index mean 30.15/100, SD 16.1; n=1923). Overall, the adolescents engaged with BeMe for an average of 2.38 (SD 2.7) days in 7.94 (SD 24.1) sessions and completed 11.26 (SD 19.8) activities. Most adolescents engaged with BeMe's content (12,270/13,421, 91.42%), mood ratings (13,094/13,421, 97.56%), and interactive skills (10,098/13,421, 75.24%), and almost one-fifth of the adolescents engaged with coaching (2539/13,421, 18.92%), clinical resources (2411/13,421, 17.96%), and crisis support resources (2499/13,421, 18.62%). Overall app engagement (total activities) was highest among female and gender-neutral adolescents compared with male adolescents (all P<.001) and was highest among younger adolescents (aged 13-14 years) compared with all other ages (all P<.001). Satisfaction ratings were generally high for content (eg, 158/176, 89.8% rated as helpful and 1044/1139, 91.66% improved coping self-efficacy), activities (5362/8468, 63.32% helpful and 4408/6072, 72.6% useful in coping with big feelings), and coaching (747/894, 83.6% helpful and 747/894, 83.6% improved coping self-efficacy). Engagement (total activities completed) predicted the likelihood of app satisfaction (P<.001). CONCLUSIONS: Many adolescents downloaded the BeMe app and completed multiple sessions and activities. Engagement with BeMe was higher among female and younger adolescents. Ratings of BeMe's content, activities, and coaching were very positive for cognitive precursors aimed at reducing depression and anxiety and improving well-being. The findings will inform future app development to promote more sustained engagement, and future evaluations will assess the effects of BeMe on changes in mental health outcomes.

Data envelopment analysis to evaluate the efficiency of tobacco treatment programs in the NCI Moonshot Cancer Center Cessation Initiative.

BACKGROUND: The Cancer Center Cessation Initiative (C3I) is a National Cancer Institute (NCI) Cancer Moonshot Program that supports NCI-designated cancer centers developing tobacco treatment programs for oncology patients who smoke. C3I-funded centers implement evidence-based programs that offer various smoking cessation treatment components (e.g., counseling, Quitline referrals, access to medications). While evaluation of implementation outcomes in C3I is guided by evaluation of reach and effectiveness (via RE-AIM), little is known about technical efficiency-i.e., how inputs (e.g., program costs, staff time) influence implementation outcomes (e.g., reach, effectiveness). This study demonstrates the application of data envelopment analysis (DEA) as an implementation science tool to evaluate technical efficiency of C3I programs and advance prioritization of implementation resources. METHODS: DEA is a linear programming technique widely used in economics and engineering for assessing relative performance of production units. Using data from 16 C3I-funded centers reported in 2020, we applied input-oriented DEA to model technical efficiency (i.e., proportion of observed outcomes to benchmarked outcomes for given input levels). The primary models used the constant returns-to-scale specification and featured cost-per-participant, total full-time equivalent (FTE) effort, and tobacco treatment specialist effort as model inputs and reach and effectiveness (quit rates) as outcomes. RESULTS: In the DEA model featuring cost-per-participant (input) and reach/effectiveness (outcomes), average constant returns-to-scale technical efficiency was 25.66 (SD = 24.56). When stratified by program characteristics, technical efficiency was higher among programs in cohort 1 (M = 29.15, SD = 28.65, n = 11) vs. cohort 2 (M = 17.99, SD = 10.16, n = 5), with point-of-care (M = 33.90, SD = 28.63, n = 9) vs. no point-of-care services (M = 15.59, SD = 14.31, n = 7), larger (M = 33.63, SD = 30.38, n = 8) vs. smaller center size (M = 17.70, SD = 15.00, n = 8), and higher (M = 29.65, SD = 30.99, n = 8) vs. lower smoking prevalence (M = 21.67, SD = 17.21, n = 8). CONCLUSION: Most C3I programs assessed were technically inefficient relative to the most efficient center benchmark and may be improved by optimizing the use of inputs (e.g., cost-per-participant) relative to program outcomes (e.g., reach, effectiveness). This study demonstrates the appropriateness and feasibility of using DEA to evaluate the relative performance of evidence-based programs.

Aniqsaaq (To Breathe): Study protocol to develop and evaluate an Alaska Native family-based financial incentive intervention for smoking cessation.

Background: Alaska Native and American Indian (ANAI) communities in Alaska are disproportionately affected by commercial tobacco use. Financial incentive interventions promote cigarette smoking cessation, but family-level incentives have not been evaluated. We describe the study protocol to adapt and evaluate the effectiveness and implementation of a remotely delivered, family-based financial incentive intervention for cigarette smoking among Alaskan ANAI people. Methods: The study has 3 phases: 1) qualitative interviews with ANAI adults who smoke, family members, and stakeholders to inform the intervention, 2) beta-test of the intervention, and 3) randomized controlled trial (RCT) evaluating intervention reach and effectiveness on verified, prolonged smoking abstinence at 6- and 12-months post-treatment. In the RCT, adult dyads (ANAI person who smokes [index participant] and family member) recruited throughout Alaska will be randomized to a no-incentives control condition (n = 328 dyads) or a 6-month incentive intervention (n = 328 dyads). All dyads will receive cessation support and family wellness materials. Smoking status will be assessed weekly for four weeks and at three and six months. Intervention index participants will receive escalating incentives for verified smoking abstinence at each time point (maximum $750 total); the family member will receive rewards of equal value. Results: A community advisory committee contributed input on the study design and methods for relevance to ANAI people, particularly emphasizing the involvement of families. Conclusion: Our study aligns with the strength and value AIAN people place on family. Findings, processes, and resources will inform how Indigenous family members can support smoking cessation within incentive interventions. Clinical Trials Registry: NCT05209451.

Current tobacco smoking and risk of SARS-CoV-2 infection and hospitalization: Evaluating the role of socio-demographic factors and comorbidities.

Our recently published study of >2.4 million adults in Northern California indicated that current versus never-tobacco smoking was associated with lower risk of SARS-CoV-2 infection and less severe coronavirus disease 2019 (COVID-19). We extended this research by evaluating whether these associations were moderated by socio-demographic factors and medical comorbidities. This retrospective cohort study of 1,885,826 adults with current or never-smoking status in Kaiser Permanente Northern California from 3/5/2020 (baseline) to 12/31/2020 (pre-vaccine) included electronic health record-based socio-demographics (sex, age, race/ethnicity, neighborhood deprivation index (NDI)) and medical comorbidities (obesity, cardiovascular conditions, diabetes, renal disease, respiratory conditions). We estimated the adjusted risk of SARS-CoV-2 infection and hospitalization (≤30 days of infection) associated with smoking status using Cox proportional hazard regression models. We estimated associations within subgroups of socio-demographics and comorbidities, and tested for effect modification using interaction terms. During the study, 35,627 patients had SARS-CoV-2 infection. Current versus never-smoking status was associated with lower adjusted rates of SARS-CoV-2 infection (aHR ranging from 0.51 to 0.89) and hospitalization (aHR ranging from 0.32 to 0.70) within nearly every socio-demographic and comorbidity subgroup. Statistically significant interactions showed that the magnitude of protection for SARS-CoV-2 infection varied by sex, age, race/ethnicity, NDI, cardiovascular conditions and diabetes, and for SARS-CoV-2 hospitalization by age and renal disease. Taken together, results indicated that while some socio-demographics and comorbidities moderated the associations, the lower risk of SARS-CoV-2 infection and hospitalization associated with current versus never-smoking status persisted among patients regardless of socio-demographics or comorbidities.

Moving outside the board room: A proof-of-concept study on the impact of walking while negotiating.

PURPOSE: Negotiation is a consequential activity that can exacerbate power differentials, especially for women. While traditional contexts can prime stereotypical gender roles and promote conditions that lead to performance differences, these can be mitigated by context shifts. This proof-of-concept study explores whether an easy-to-apply context shift, moving from seated indoors to walking outside, can help improve the quality of negotiated interactions. Here we examine walking's effects on negotiation and relational outcomes as well as experienced emotions, moderated by gender. DESIGN: Same-gender pairs were randomly assigned to either sitting or walking as either candidate or recruiter negotiating a job offer. PARTICIPANTS: Eighty-one pairs of graduate students or community members participated: sitting pairs: 27 women, 14 men; walking pairs: 23 women, 17 men. INTERVENTION: Participants negotiated either while seated (across from each other) or walking (side by side along a path). MEASURES: We measured: negotiation performance (total points) and outcome equity (difference between negotiating party points); subjective outcomes of positive emotions, negative emotions, mutual liking, and mutual trust. With mixed effects models, we tested main effects of condition, gender, and interaction of condition x gender. RESULTS: Relative to sitting, walking was associated with: increased outcome equality for women, but decreased for men (B = 3799.1, SE = 1679.9, p = .027); decreased negative emotions, more for women than men (IRR = .83, 95% CI:[.69,1.00], p = .046); and greater mutual liking for both genders (W = 591.5, p-value = 0.027). No significant effects were found for negotiation point totals, positive emotions, or mutual trust. CONCLUSION: This study provides a foundation for investigating easy-to-implement changes that can mitigate stereotyped performance differences in negotiation.

Rapid-response surveillance of the first US test market for VLN cigarettes.

INTRODUCTION: VLN King menthol and non-menthol are the first combustible cigarettes to receive US Food and Drug Administration (FDA) authorisation as modified risk tobacco products. Focusing on the first retail test market, this study characterised VLN advertising, product placement, discounts and price. METHODS: All Chicago-area Circle K stores (n=133) were telephoned to assess whether they sold VLN. Single-pack price of non-menthol was obtained in 57 of 100 stores that sold VLN. In fall 2022, trained data collectors visited those 57 stores to assess VLN product placement, advertising, discounts and prices. Paired t-tests compared observed VLN price with telephone price and to price of other cigarette brands. RESULTS: Nearly all stores (91.1%) displayed exterior advertisements for VLN, and 41.1% displayed interior advertising, with 8.9% of stores advertising VLN in the power wall but never in the header row. VLN cigarettes were displayed in the power wall exclusively and among high-nicotine cigarettes. Some VLN marketing claims were not FDA-authorised. VLN advertised a sweepstakes offer and rewards programme. Most stores (85.7%) offered VLN discounts. VLN was priced like a premium brand (mean=$10.90, SD=$1.53), and prices obtained by telephone did not differ from observed prices several months later. CONCLUSIONS: Retail marketing strategies for VLN mimic those for high-nicotine cigarettes. Deviations from FDA-authorised marketing claims were evident. Surveillance in future test markets is recommended to assess compliance with marketing claims and examine relative price and discount offers. Of interest is how premium-priced, low-nicotine cigarettes stand to compete in a market dominated by cheaper high-nicotine cigarettes.

A relational agent for treating substance use in adults: Protocol for a randomized controlled trial with a psychoeducational comparator.

BACKGROUND: Substance use disorders (SUDs) are prevalent and compromise health and wellbeing. Scalable solutions, such as digital therapeutics, may offer a population-based strategy for addressing SUDs. Two formative studies supported the feasibility and acceptability of the relational agent Woebot, an animated screen-based social robot, for treating SUDs (W-SUDs) in adults. Participants randomized to W-SUDs reduced their substance use occasions from baseline to end-of-treatment (EOT) relative to a waitlist control. OBJECTIVE: To further develop the evidence base, the current randomized trial extends follow-up to 1-month post-treatment and will test the efficacy of W-SUDs relative to a psychoeducational control. METHODS: This study will recruit, screen, and consent 400 adults online reporting problematic substance use. Following baseline assessment, participants will be randomized to 8 weeks of W-SUDs or a psychoeducational control. Assessments will be conducted at weeks 4, 8 (EOT), and 12 (1-month post-treatment). Primary outcome is past-month number of substance use occasions, summed across all substances. Secondary outcomes are number of heavy drinking days, the percent of days abstinent from all substances, substance use problems, thoughts about abstinence, cravings, confidence to resist substance use, symptoms of depression and anxiety, and work productivity. If significant group differences are found, we will explore moderators and mediators of treatment effects. CONCLUSIONS: The current study builds upon emerging evidence of a digital therapeutic for reducing problematic substance use by examining sustained effects and testing against a psychoeducational control condition. If efficacious, the findings have implications for scalable mobile health interventions for reducing problematic substance use. TRIAL REGISTRATION: NCT04925570.

Understanding Hesitation to Use Nicotine Replacement Therapy: A Content Analysis of Posts in Online Tobacco-Cessation Support Groups.

PURPOSE: We aimed to better understand hesitancy to use nicotine replacement therapy (NRT) to quit smoking. DESIGN: We content coded and analyzed NRT-related posts in online quit smoking support groups to understand NRT-use hesitancy and to examine associations with health outcomes. SETTING: NRT posts were analyzed in unmoderated social-media support groups with free NRT. SAMPLE: Adults who smoked daily (n = 438) and posted about NRT were studied, 339 of whom reported on NRT usage and 403 reported on smoking abstinence. MEASURES: Surveys at 1-month post-quit date assessed NRT usage and smoking abstinence. ANALYSIS: Relationships among NRT posts, NRT usage and smoking abstinence were analyzed using GEE models accounting for support group and covariates. RESULTS: Nearly all (96.17%) participants reported using the study-provided NRT once, most (70.21%) used NRT during the past week, but less than half (45.72%) used NRT daily for the full month as recommended. Nearly two-thirds (65.34%) of NRT posts were negative. Posts reflecting dislike or no longer needing NRT were associated with a lower likelihood of using NRT in the past week at least once (B = -.66, P = .005 and B = -.37, P = .045), use occasions (B = -1.86, P = .018 and B = -1.10, P = .016) and used daily for full month (B = -.56, P = .044 and B = -.53, P = .009). Posts related to the effectiveness of NRT related to past-week NRT used at least once (B = .15, P = .023), used daily for full month (B = .25, P = .001), and smoking abstinence (B = .27, P = .002). CONCLUSION: Strategies are needed to address dislike of NRT and strengthen perceptions of NRT efficacy, especially on social media where posts may be amplified.

Native owned and grown or demeaning and offensive? American Indian adults' perspectives on Natural American Spirit branded cigarettes.

INTRODUCTION: Owned by a major US tobacco company with no American Indian/Alaska Native (AI/AN) tribal affiliation, Natural American Spirit (NAS) cigarette packs feature an American Indian warrior, thunderbird and peace pipe. The current study examined AI/AN adults' perceptions of NAS cigarette packs in the US, which have not been reported on prior. METHODS: AI/AN adults were recruited via Qualtrics national panels (n=500; 64% female, age M=39.9 years, 47% current smokers) in 2020. After viewing NAS pack images online (front, back and sides), participants were asked about NAS tribal affiliation, health perceptions and purchase intentions. Participants also wrote-in what the NAS pack logos meant to them. RESULTS: Most participants (65%) believed NAS is AI/AN-owned and/or grown on tribal lands. Among current smokers, beliefs of an AI/AN affiliation were associated with misperceptions of NAS being a healthier cigarette and with greater intention to purchase NAS cigarettes (p's<0.01). Participants who did not believe NAS was grown or owned by AI/AN tribes were more likely to describe the NAS warrior logo as cultural misappropriation (17%) than participants who believed NAS was AI/AN tribally affiliated (4%, p<0.001). CONCLUSIONS: The findings indicate a dichotomy in beliefs among surveyed AI/AN adults regarding NAS brand cigarettes. A majority held the misconception that NAS is tribally affiliated, while an informed and concerned minority characterised the branding as cultural misappropriation. The current packaging is reasonably expected to result in beliefs that NAS cigarettes are AI/AN tribally affiliated, and these beliefs may be associated with misperceptions of lesser harm.

Tobacco Smoking and Risk of SARS-CoV-2 Infection and Disease Severity Among Adults in an Integrated Healthcare System in California.

INTRODUCTION: The relationship between tobacco smoking status and SARS-CoV-2 infection and coronavirus disease 2019 (COVID-19) severity is highly debated. We conducted a retrospective cohort study of >2.4 million adults in a large healthcare system to evaluate whether smoking is associated with SARS-CoV-2 infection and disease severity. AIMS AND METHODS: This retrospective cohort study of 2,427,293 adults in KPNC from March 5, 2020 (baseline) to December 31, 2020 (pre-vaccine) included smoking status (current, former, never), socio-demographics, and comorbidities from the electronic health record. SARS-CoV-2 infection (identified by a positive PCR test) and COVID-19 severity (hospitalization, ICU admission or death ≤ 30 days of COVID-19 diagnosis) were estimated in time-to-event analyses using Cox proportional hazard regression models adjusting for covariates. Secondary analyses examined COVID-19 severity among patients with COVID-19 using logistic regression. RESULTS: During the study, 44,270 patients had SARS-CoV-2 infection. Current smoking was associated with lower adjusted rates of SARS-CoV-2 infection (aHR = 0.64 95% CI: 0.61-0.67), COVID-19-related hospitalization (aHR = 0.48 95% CI: 0.40-0.58), ICU admission (aHR = 0.62 95% CI: 0.42-0.87), and death (aHR = 0.52 95% CI: 0.27-0.89) than never-smoking. Former smoking was associated with a lower adjusted rate of SARS-CoV-2 infection (aHR = 0.96 95% CI: 0.94-0.99) and higher adjusted rates of hospitalization (aHR = 1.10 95% CI: 1.03-1.08) and death (aHR = 1.32 95% CI: 1.11-1.56) than never-smoking. Logistic regression analyses among patients with COVID-19 found lower odds of hospitalization for current versus never-smoking and higher odds of hospitalization and death for former versus never-smoking. CONCLUSIONS: In the largest US study to date on smoking and COVID-19, current and former smoking showed lower risk of SARS-CoV-2 infection than never-smoking, while a history of smoking was associated with higher risk of severe COVID-19. IMPLICATIONS: In this cohort study of 2.4 million adults, adjusting for socio-demographics and medical comorbidities, current tobacco smoking was associated with a lower risk of both SARS-CoV-2 infection and severe COVID-19 illness compared to never-smoking. A history of smoking was associated with a slightly lower risk of SARS-CoV-2 infection and a modestly higher risk of severe COVID-19 illness compared to never-smoking. The lower observed COVID-19 risk for current versus never-smoking deserves further investigation. Results support prioritizing individuals with smoking-related comorbidities for vaccine outreach and treatments as they become available.

Facebook Intervention to Connect Alaska Native People With Resources and Support to Quit Smoking: CAN Quit Pilot Randomized Controlled Trial.

INTRODUCTION: There is some evidence that social media interventions can promote smoking cessation. This randomized controlled pilot study is the first to evaluate the feasibility and potential efficacy of a Facebook smoking cessation intervention among Alaska Native (AN) adults. AIMS AND METHODS: Recruitment and data collection occurred from December 2019 to March 2021. Participants were recruited statewide in Alaska using Facebook advertisements with a targeted sample of 60 enrolled. Participants were stratified by gender, age, and rural or urban residence and randomly assigned to receive referral resources on evidence-based cessation treatments (EBCTs) (control, n = 30) or these resources plus a 3-month, closed (private), culturally tailored, Facebook group (intervention, n = 31) that connected participants to EBCT resources and was moderated by two Alaska Native Trained Tobacco Specialists. Assessments were conducted online post-randomization at 1, 3, and 6 months. Outcomes were feasibility (recruitment, retention, and intervention engagement), self-reported use of EBCTs, and biochemically confirmed seven-day point-prevalence smoking abstinence. RESULTS: Of intervention participants, 90% engaged (eg posted, commented) more than once. Study retention was 57% at 6 months (no group differences). The proportion utilizing EBCTs was about double for intervention compared with the control group participants at 3 and 6 months. Smoking abstinence was higher for intervention than control participants at 3 months (6.5% vs. 0%, p = .16) but comparable at 6 months (6.4% vs. 6.7%, p = .97). CONCLUSIONS: While additional research is needed to promote long-term cessation, this pilot trial supports recruitment feasibility during the Coronavirus Disease 2019 (COVID-19) pandemic, consumer uptake, and a signal for intervention efficacy on the uptake of cessation treatment and short-term smoking abstinence. IMPLICATIONS: This study is the first evaluation of a social media intervention for smoking cessation among Indigenous people. We learned that statewide Facebook recruitment of AN adults who smoke was feasible and there was a signal for the efficacy of a Facebook intervention on the uptake of EBCT and short-term (3 months) biochemically verified smoking abstinence. Clinically, social media platforms may complement current care models by connecting AN individuals and others living in hard-to-reach communities to cessation treatment resources.