Effect of a Personalized Tobacco Treatment Intervention on Smoking Abstinence in Individuals Eligible for Lung Cancer Screening.

INTRODUCTION: To determine whether personalized gain-framed messaging and biomarker feedback related to tobacco cessation or reduction decrease smoking behavior in patients undergoing or eligible for lung cancer screening. METHODS: Between 2016 and 2020, 188 patients were enrolled in a two-phase, sequential, randomized controlled trial. Phase 1 evaluated whether standard of care (SC) (five in-person counseling sessions and 8 weeks of nicotine patch) plus gain-framed messaging (GFM) versus SC would increase 8-week biochemically verified smoking cessation rates. In 143 participants randomized in phase 2, we tested whether feedback on smoking-related biomarkers would reduce 6-month self-reported number of cigarettes smoked per day compared with a no feedback control. Chi-square test and mixed effects repeated measures analyses were used to evaluate group differences. RESULTS: Participants were 62.5 ± 5.6 (mean ± SD) years of age, had a 50.3 ± 21 pack-year smoking history, and were smoking 16.9 ± 9.9 cigarettes per day. At 8 weeks, there was no difference in quit rates between those randomized to SC plus GFM (n = 15 of 93, 16.1%) and those randomized to SC (n = 16 of 95, 16.8%), with p equals to 0.90. At the 6-month post-randomization follow-up, number of cigarettes smoked per day was similar in the feedback (least-squares mean = 7.5, 95% confidence interval: 6.0-9.1) and no feedback arms (7.7, 95% confidence interval: 6.2-9.3), with p equals to 0.87. CONCLUSIONS: Gain-framed messaging and health feedback did not significantly improve quit rates relative to comprehensive standard of care. Nevertheless, the overall program achieved clinically meaningful smoking quit rates in this older high pack-year cohort, highlighting the importance of intensive tobacco treatment for patients undergoing lung cancer screening. CLINICAL TRIAL REGISTERED WITH CLINICALTRIALS.GOV: NCT02658032.

Smoking Cessation Pharmacotherapy Efficacy in Comorbid Medical Populations: Secondary Analysis of the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) Randomized Clinical Trial.

INTRODUCTION: This study sought to compare medication efficacy in participants with medical comorbidities who smoke in the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) trial, a double-blind, triple-dummy, placebo- and active-controlled randomized controlled trial. AIMS AND METHODS: Participants were from the U.S. cohort of the main trial and randomized (1:1:1:1) to varenicline, bupropion, nicotine replacement therapy (NRT) patch, or placebo for 12 weeks with follow-up through week 24. Medical comorbidity data were derived from the baseline medical screening questionnaire and categorized into four subgroups (cardiac, respiratory, vascular, and diabetes). Within each comorbidity, generalized linear mixed models were used to assess the association between treatment and continuous abstinence rates from weeks 9-12 to 9-24. Similar models were used to test the effect of number of comorbidities on abstinence. RESULTS: Varenicline resulted in the highest week 12 abstinence rates across all pharmacotherapies and compared to placebo in all comorbidity subgroups: Cardiac (40.0% vs. 3.6%; odds ratios [OR] = 23.3 [5.1-107.1]), respiratory (24.7% vs. 12.8%; OR = 2.2 [1.3-3.8]), vascular (29.1% vs. 10.4%; OR = 3.6 [2.3-5.7]), and diabetes (30.9% vs. 8.3%; OR = 6.5 [2.3-19.0]). This was maintained at week 24 for those with cardiac (23.3% vs. 1.8%; OR = 21.7 [2.7-178.2]), vascular (18.9% vs. 7.1%; OR = 3.1 [1.8-5.3]), and diabetes (20.6% vs. 4.2%; OR = 8.4 [2.1-33.7]) comorbidities. Treatment contrasts within some comorbidity subgroups revealed superior efficacy of varenicline over other pharmacotherapies. All pharmacotherapies increased the odds of abstinence regardless of number of comorbidities. CONCLUSIONS: Varenicline is the most efficacious option for patients with manageable cardiac, respiratory, vascular, and diabetes conditions to quit smoking, supporting recent clinical practice guidelines that recommend varenicline as first-line pharmacotherapy. Bupropion and NRT demonstrated efficacy for some comorbidity subgroups. IMPLICATIONS: This secondary analysis of the EAGLES trial demonstrated that varenicline is the most efficacious option for patients with cardiac, respiratory, vascular, and diabetes diagnoses to quit smoking. This demonstration of varenicline efficacy among individuals with comorbid medical conditions supports recent clinical practice guidelines that recommend varenicline as a first-line pharmacotherapy for smoking cessation.

Shift From Smoking Cigarettes to Vaping Nicotine in Young Adults.

This survey study assesses trends in nicotine use among young adults in the US between 2013 and 2021.

Implementation of an "Opt-Out" Tobacco Treatment Program in Six Hospitals in South Carolina.

Objective: To describe the implementation an opt-out tobacco treatment program (TTP) in 6 diverse hospitals located in different regions of South Carolina. Methods: Between March 8, 2021 and December 17, 2021, adult patients (≥ 18 years) admitted to 6 hospitals affiliated with the Medical University of South Carolina (MUSC) were screened for their cigarette status. Patients who smoked cigarettes were referred to an TTP offering a brief bedside consult and automated post-discharge follow-up calls with an opportunity to receive a referral to the South Carolina Quitline (SCQL). The hospitals included in this study ranged in size from 82 to 715 beds with diverse patient populations. Herein, we report on the results of screening and referring patients to the TTP, delivery of smoking cessation treatments, and patient smoking status assessed in a sample of patients followed 6-weeks after discharge from the hospital. Results: Smoking prevalence ranged from 14-49% across the 6 hospitals. Among eligible patients reached, 85.6% accepted the bedside consult. Only 3.4% of patients reached were deemed ineligible because they claimed not to be currently smoking cigarettes. The automated post-discharge follow-up calls were answered by 43% of patients, with about a third of those who had relapsed back to smoking accepting the offer of a referral to the SCQL. Overall, about half of the 6,000 patients referred to the TTP received some type of treatment. Self-reported smoking abstinence rates assessed 6-weeks after discharge were similar across the five acute care hospitals ranging from about 20-30%. Conclusion: The findings demonstrate the broad reach of implementing an opt-out TTP for patients in hospitals of varying size, rurality and patient populations.

A Secondary Analysis of a Preliminary Contingency Management Intervention for Presurgical Cancer Patients: Evaluating Individual Participant Data.

INTRODUCTION: Contingency management (CM) interventions deliver monetary reinforcers contingent upon biochemically verified abstinence from smoking. CM has been found to be effective, however, individual participant, analyses are warranted to further elucidate how individual-level behavior patterns vary during the intervention period, both within and across treatment groups. AIMS AND METHODS: This is a secondary analysis of a randomized controlled pilot trial of presurgical cancer patients who smoke (RCT N = 40). All participants were current everyday smokers and were enrolled in cessation counseling, offered nicotine replacement therapy, and submitted breath CO testing 3 times per week for 2-5 weeks. Participants randomized to CM received monetary reinforcers for breath CO ≤6 ppm on an escalating schedule of reinforcement with a reset for positive samples. Sufficient breath CO data exist for 28 participants (CM = 14; monitoring only [MO] = 14). Effect size was calculated for differences in negative CO tests. Time to first negative test was tested using survival analysis. Fisher's exact test was used to assess relapse. RESULTS: The CM group achieved abstinence more quickly (p < .05), had a lower percentage of positive tests (h = 0.80), and experienced fewer lapses following abstinence (p = .00). While 11 of 14 participants in the CM group achieved and sustained abstinence by their third breath test, this was only true for 2 of the 14 MO participants. CONCLUSIONS: Those in CM achieved abstinence quicker and with fewer lapses than those engaged in MO speaking to the efficacy of the schedule of financial reinforcement. This is particularly important within presurgical populations given the potential benefits to postoperative cardiovascular and wound infection risk. IMPLICATIONS: While the efficacy of CM as an intervention is well established, this secondary analysis provides insight into the individual behavior patterns underlying successful abstinence. Those assigned to CM were not only more likely to achieve abstinence, but did so more quickly and with fewer instances of relapse. This is of particular importance to those scheduled for surgery where achieving abstinence as early as possible impacts on the risk of postoperative complications. CM interventions may be particularly well suited for critical windows in which timely and sustained abstinence is advantageous.

Tobacco use and cancer-related symptom burden: Analysis of the US Population Assessment of Tobacco and Health Study.

BACKGROUND: Understanding the relationship between tobacco use and symptom burden may inform tobacco treatment interventions tailored to the needs of individuals with cancer. METHODS: The study included 1409 adult cancer survivors from Wave 5 of the US Food and Drug Administration Population Assessment of Tobacco and Health (PATH) Study. A multivariate analysis of variance controlling for age, sex, and race/ethnicity assessed the association of cigarette smoking and vaping on cancer-related symptom burden (fatigue, pain, emotional problems) and quality of life (QoL). Generalized linear mixed models controlling for the same factors were used to assess associations among symptom burden, QoL, and quit-smoking intentions, quit-smoking likelihood, and past 12-month smoking quit attempts. RESULTS: Weighted rates of current cigarette smoking and vaping were 14.21% and 2.88%, respectively. Current smoking was associated with greater fatigue (p < .0001; partial η 2  = .02), pain (p < .0001; partial η 2  = .08), emotional problems (p < .0001; partial η 2  = .02), and worse QoL (p < .0001; partial η 2  = .08). Current vaping was associated with greater fatigue (p = .001; partial η 2  = .008), pain (p = .009; partial η 2  = .005), and emotional problems (p = .04; partial η 2  = .003), but not worse QoL (p = .17). Higher cancer symptom burden was not associated with reduced interest in quitting, likelihood of quitting, or odds of past year quit attempts (p > .05 for each). CONCLUSIONS: Among adults with cancer, current smoking and vaping were associated with greater symptom burden. Survivors' interest in and intentions to quit smoking were not related to symptom burden. Future research should examine the role of tobacco cessation in improving symptom burden and QoL.

E-Cigarette Screening in Primary Care.

INTRODUCTION: Primary care visits present an opportune time to assess behaviors that contribute to patient health. Smoking, alcohol use, and illicit drugs are routinely documented in electronic health records, but less is known about screening for E-cigarette use and the prevalence of E-cigarette use in primary care settings. METHODS: Data include 134,931 adult patients who visited 1 of 41 primary care clinics within a 12-month period (June 1, 2021-June 1, 2022). Data on demographics, combustible tobacco, alcohol, illicit drug, and E-cigarette use were extracted from electronic medical records. Logistic regression was utilized to examine the variables associated with differential odds of being screened for E-cigarette use. RESULTS: Rates of E-cigarette screening (n=46,997; 34.8%) were significantly lower than that of tobacco (n=134,196; 99.5%), alcohol (n=129,766; 96.2%), and illicit drug (n=129,766; 92.6%) use. Of those assessed for E-cigarette use, 3.6% (n=1,669) reported current use. Of those with documented nicotine use (n=7,032), 17.2% (n=1,207) used mono E-cigarettes exclusively, 76.3% (n=5,364) used combustible tobacco exclusively, and 6.6% (n=461) reported dual use (both E-cigarette use and combustible tobacco use). Those who used combustible tobacco or illicit substances as well as younger patients were more likely to have been screened for E-cigarette use. CONCLUSIONS: Overall rates of E-cigarette screening were significantly lower than those of other substances. The use of combustible tobacco or illicit substances was associated with an increased likelihood of being screened. This finding may be because of the relatively recent proliferation of E-cigarettes, the recent addition of E-cigarette documentation to the electronic health record, or a lack of training on screening for E-cigarette use.

Interest in quitting e-cigarette use by device type and smoking history in US adults.

BACKGROUND: The use of e-cigarettes has been increasing, especially since the introduction of 'pod' devices to the marketplace since 2018. Most adults who vape report interest in quitting. The present study examined level of interest in e-cigarette cessation between users with varying cigarette smoking histories and device types. METHODS: Data obtained from wave 5 (2018-2019) of the Population Assessment of Tobacco and Health study (n=34 309). Analyses were conducted on adult current established e-cigarette users, categorised on cigarette smoking history (current, former or never) and device type (disposable, cartridge/pod, tank or mod). Participants reported if they planned to ever quit e-cigarettes, attempted to quit in the past year and attempted to quit by cutting back in the past year. RESULTS: Of the 2922 established e-cigarette users, 68.21% reported plans to quit vaping; 17.27% reported attempting to quit e-cigarettes in the past year; and 29.28% reported attempting to quit by cutting back in the past year. Cartridge users had higher odds of interest in quitting than tank and mod users. Disposable and cartridge users had higher odds of reporting a past year quit attempt than tank and mod users. Individuals with no smoking history had higher odds of reporting a past year quit attempt or cutting back relative to those reporting dual use (of both e-cigarettes and cigarettes) and former smoking. CONCLUSIONS: Tobacco control should consider the type of e-cigarette device that is being used, alongside users' cigarette smoking history, when developing interventions and other resources for vaping cessation.

Nicotine replacement therapy for vaping cessation among mono and dual users: A mixed methods preliminary study.

Many adults express interest in e-cigarette cessation; however, there are few empirically tested interventions for quitting vaping. This study seeks to (1) evaluate reasons for quitting e-cigarettes in treatment-seeking adults, and (2) assess the feasibility and acceptability of nicotine replacement therapy (NRT) for e-cigarette cessation. Adult daily e-cigarette users completed qualitative interviews about quitting e-cigarettes, then were randomized to either 28-day supply of combination NRT (21 mg patches, 4 mg lozenges) + supportive booklet or Quitline referral. Primary aims were feasibility (number who enrolled) and acceptability (NRT use, adverse side effects). Exploratory aims evaluated abstinence (7-day point-prevalence) at end of treatment. Of the 30 participants who were enrolled, 50 % (n = 15) were dual users, and 50 % (n = 15) were mono-vapers, 26.6 % (n = 8) of whom were former smokers. Participants reported seeking treatment due to health concerns, dependence, stigma, and cost. Anticipated challenges of quitting vaping were withdrawal, negative mood, sensorimotor habits, and convenience. Most completed the end of treatment survey (n = 24; 80 %). Participants who received NRT reported using the patch M = 10.89 days and lozenges M = 6.39 days, with few days of adverse effects (M = 2.67). At end of treatment, 6/18 (33.3 %; 6 mono and 0 dual users) in the intervention group reported abstinence from vaping, compared to 0 in the control group (Fisher = 5.00, p =.057). In conclusion, adults are interested in quitting e-cigarettes due to negative consequences of use and are willing to use pharmacotherapy. Future research should confirm these results in a larger trial, address cigarette smoking in dual users, and aim to disseminate treatments.

Factors Associated With Smoking Cessation Attempts in Lung Cancer Screening: A Secondary Analysis of the National Lung Screening Trial.

BACKGROUND: Lung cancer remains the leading cause of cancer-related mortality in the United States. The National Lung Screening Trial (NLST) demonstrated a 20% reduction in lung cancer mortality resulting from lung cancer screening (LCS) with an additive reduction from smoking abstinence. However, successful smoking cessation within LCS is variable. RESEARCH QUESTION: What patient and treatment factors are associated with attempts to quit smoking among those screened for lung cancer? STUDY DESIGN AND METHODS: In a secondary analysis of the American College of Radiology Imaging Network arm of the NLST, patient demographics, patient smoking behaviors, and tobacco treatment variables were stratified by patient smoking status. The Cox proportional hazards ratio was used to evaluate each variable's effect on attempting to quit smoking. RESULTS: Seven thousand three hundred sixty-nine patients were smoking actively at enrollment in the NLST. Of the patients who reported they were smoking, 73.4% did not receive any pharmacologic tobacco treatment. More patients who attempted to quit received pharmacologic tobacco treatment than those who continued to smoke: (nicotine replacement therapy [NRT], 18.0% vs 12.4% [P < .01]; bupropion, 7.9% vs 6.9% [P = .02]; both NRT and bupropion, 5.6% vs 3.9% [P < .01]). Stable users were more likely to be women (47.8% vs 43.8%; P < .01), to be African American (8.2% vs 6.3%; P = .007), to be unmarried (43.2% vs 36.9% [P < .01]), and to have less than a college education (47.7% vs 42.3%; P < .01). Patients with high dependence who received dual therapy with bupropion and NRT showed the highest likelihood of quit attempt (hazard ratio, 2.07; 95% CI, 1.75-2.44). INTERPRETATION: In this analysis, only one-quarter of patients who underwent LCS and who smoked were treated with pharmacologic therapy, which is associated with increased likelihood of attempting to quit. Certain characteristics are associated with difficulty with attempting to quit smoking. Those with high nicotine dependence benefitted most from dual pharmacologic therapy.

Optimizing tobacco treatment delivery for people with HIV: trial protocol for a randomized controlled trial.

BACKGROUND: With advances in antiretroviral therapy, people with HIV (PWH) are living longer and are less likely to die from AIDS-related complications. Yet, prior research has shown that smoking is often not addressed in the context of HIV care, and few individuals are offered cessation treatment. Optimizing tobacco treatment delivery for PWH may increase engagement with evidence-based treatments and successful quit attempts. METHODS: The current study is a type 1 hybrid effectiveness-implementation trial to evaluate the impact of a proactive, opt-out tobacco treatment intervention on cessation outcomes and advance understanding of key barriers and facilitators of implementation processes. A total of 230 PWH who smoke will be recruited from an infectious diseases clinic at an academic medical center and will be randomized to receive (1) treatment as usual (TAU) or (2) Proactive Outreach with Medication Opt-out for Tobacco Treatment Engagement (PrOMOTE). Primary outcomes include: biochemically verified 7-day point prevalence abstinence (PPA) rates, continuous abstinence (Weeks 9-12), and the number of 24-hour quit attempts at the end of study treatment (Week 12). Secondary outcomes include: participant reach (proportion reached out of contact attempts), implementation fidelity (including number of prescriptions written), participant adherence to prescribed pharmacotherapy, acceptability (participant and provider satisfaction with intervention delivery and content), and perceived barriers. DISCUSSION: This study will examine a novel approach to optimizing tobacco treatment delivery for PWH. Integrating effectiveness and implementation results will help define best practices for engaging PWH with evidence-based tobacco treatment interventions. The intervention is low-cost, has the potential to be highly scalable, and could be translatable to other ambulatory HIV clinic settings. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05019495 (August 24, 2021).

Accelerating integration of tobacco use treatment in the context of lung cancer screening: Relevance and application of implementation science to achieving policy and practice.

Based on the findings from the National Lung Screening Trial, the U.S. Preventive Services Task Force recommends annual low dose computed tomography (LDCT) lung cancer screening (LCS) among high-risk adults. Approximately 54% of individuals seeking LCS report current cigarette smoking. Effective smoking cessation interventions, offered at the time of LCS, enhances the health benefits of screening that are attributable to reductions in lung cancer overall and tobacco-related mortality. Considering these data, the Centers for Medicare & Medicaid Services' (CMS) 2015 decision to cover LCS with LDCT required that radiology imaging facilities make tobacco cessation interventions available for people who smoke. In February 2022, CMS reversed their 2015 coverage requirement for delivering tobacco use treatment at the time of LDCT; CMS retained the requirement for counseling during the shared decision-making visit prior to the exam. The policy change does not diminish the importance of offering high-quality tobacco cessation services in conjunction with routine LDCT for LCS. However, LCS programs face a range of barriers to implementing tobacco use treatment in their settings. As a result, implementation has lagged. Closing the "evidence to practice" gap is the focus of implementation science, a field that offers a set of rigorous methods and a systematic approach to identifying and overcoming contextual barriers to implementing evidence-based guidelines in a range of clinical settings. In this paper, we describe how implementation science frameworks and methods can be used to help guide LCS programs in their efforts to integrate tobacco use treatment and discuss policy changes needed to further facilitate the delivery of TUT as an essential component of the LCS process.

Lung cancer is the leading cause of cancer death in the United States. There is strong evidence, from a large number of international studies, that lung cancer screening for people who meet specific criteria, can reduce lung cancer-related deaths. Based on these findings, the Centers for Medicare and Medicaid decided to provide insurance coverage for lung cancer screening for eligible patients. This includes people aged 50­80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years. Over 50% of people who seek lung cancer screening report current cigarette smoking. Studies show that offering these smokers support to quit at the time of screening can further increase survival rates by reducing both deaths from lung cancer and other tobacco-related diseases. Unfortunately, lung cancer screening programs do not consistently provide effective treatments to help smokers quit. This is a missed opportunity to engage smokers in quitting when the health risk of tobacco use is most salient, and therefore smokers may be more willing to engage in tobacco use treatment. This paper provides detailed guidance on how programs can implement high quality tobacco use treatment services in conjunction with lung cancer screening.

Optimizing the Implementation of Tobacco Treatment for People with HIV: A Pilot Study.

People with HIV (PWH) have higher rates of tobacco use compared to their societal counterparts and are disproportionately affected by tobacco-related morbidity and mortality. A needs assessment was conducted to assess provider beliefs and opinions on tobacco treatment barriers and treatment approaches. The results highlighted a disconnect between the known importance of quitting smoking and barriers in linking patients to treatment, such as lack of patient interest and other patient issues being a higher priority. Using this assessment data, a treatment delivery approach, Proactive Outreach with Medication Opt-out for Tobacco Treatment Engagement (PrOMOTE), was devised and piloted. PrOMOTE consisted of an outpatient clinical pharmacist trained in tobacco treatment proactively contacting patients for counseling and to prescribe smoking cessation pharmacotherapy (varenicline or dual nicotine replacement therapy (NRT)) using an opt-out approach. The pilot was conducted with 10 PWH and patient reach and opt-out rates were evaluated. Of the 10 patients contacted, 7 were reached and none opted out of the pharmacotherapy prescription (varenicline = 6; NRT = 1). Providers know the importance of smoking cessation for PWH but encounter several barriers to implementing treatment. Using PrOMOTE methods to deliver tobacco treatment increased the reach and pharmacotherapy acceptance rate of PWH who smoke.

Tobacco Treatment Outcomes for Hospital Patients With and Without Mental Health Diagnoses.

Background: The prevalence of mental health conditions is higher in cigarette smokers than nonsmokers. However, those with diagnosed mental health disorders are understudied within general inpatient hospital settings. This study seeks to evaluate how having a mental health diagnosis influences response to a brief opt-out inpatient tobacco treatment intervention. Methods: Data included 4,153 admitted patients who completed a tobacco treatment visit. Post-discharge self-reported abstinence was obtained via response to an automated call 1-month after discharge. Mental health co-morbidities were assessed by reviewing electronic medical records. Logistic regression was used to assess associations between having a mental health diagnosis and patients' smoking history, interest in quitting smoking, and post-discharge abstinence. Results: Overall 34.1% of patients were diagnosed with mental health disorders, most commonly depression or substance use disorders. Patients with a diagnosed mental health disorder were more likely to report a history of long-term heavy smoking and were less likely to express an interesting in remaining abstinent from smoking after hospitalization. An intent-to-treat analysis using logistic regression analysis found lower rates of self-reported smoking abstinence in those with a mental health disorder compared to those without (9 vs. 13.2%, p < 0.001). Conclusions: Patients with a history of mental health diagnoses, such as depression or substance use disorders, was associated with lower rates of smoking abstinence in patients after hospitalization. Hospital based opt-out smoking cessation programs have shown to be generally effective and efficient. However, certain subpopulations may require tailored intervention in order to improve treatment outcomes. Future research is needed to develop brief, effective tobacco treatment for hospital patients with comorbid mental health diagnoses.

Reappraising Choice in Addiction: Novel Conceptualizations and Treatments for Tobacco Use Disorder.

The introduction of alternative nicotine and tobacco products (such as e-cigarettes, heat-not-burn devices, nicotine pouches) warrants an updated framework from which to conceptualize tobacco use disorder (TUD). The following review provides considerations for TUD within the context of novel products. Historically, the tobacco industry falsely claimed that cigarettes were not addictive or harmful and that those who smoked simply chose to do so. This generated an inaccurate lay perception that smoking is a free or informed choice. Research on nicotine pharmacology demonstrates the powerful addictive potential of nicotine, which is shaped by dose, speed of delivery, and other constituents generated. In addition, non-pharmacologic reinforcers motivate and maintain tobacco use behaviors for both traditional cigarettes and novel products. The negative consequences of combustible tobacco use are well known; however, these outcomes may differ for alternative products. Strategies used for combustible product cessation may be adapted for novel products, and treatment recommendations for TUD should be made within the context of a harm reduction framework wherein alternative product use may be the desired outcome. Providers must therefore be willing to modify their perceptions of products and treatment recommendations accordingly. Better public health outcomes are accomplished through promotion of abstinence from combustible smoking. For those who cannot wean from nicotine entirely, switching to less risky modes of delivery might be a secondary goal, with an eventual aim of stopping use of the alternative product. Implications: Given the advent of novel, alternative tobacco products, tobacco use disorder (TUD) must be conceptualized within a contemporary framework that includes harm reduction and alternative outcomes. The unique contributions of nicotine pharmacology, non-pharmacologic reinforcers, and consequences of use can be used to inform treatments for TUD with the ultimate goal of improving the health of individuals who use tobacco.

Reporting Treatment Fidelity in Behavioral Tobacco Treatment Clinical Trials: Scoping Review and Measurement Recommendations.

INTRODUCTION: Adoption of rigorous standards for reporting treatment fidelity is essential for advancing discovery, validation, and implementation of behavioral treatments. Whereas the NIH Behavior Change Consortium (BCC) developed an assessment tool to assess the quality of reporting and monitoring of treatment fidelity across health behavior change interventions, it has not yet been applied specifically to treatment fidelity in behavioral tobacco treatment trials. AIMS AND METHODS: We conducted a scoping review of peer-reviewed, clinical trials of behavioral adult tobacco treatment interventions published in English between 2006 and 2018. Using the BCC treatment fidelity checklist, articles were coded for the presence or absence of various treatment fidelity strategies within each of 5 domains: Design, Training, Delivery, Receipt, and Enactment. Eligible articles (N = 755) were coded by two independent coders. RESULTS: The proportion of reporting strategies varied within the fidelity domains, ranging from 5.2% to 96.3% in Design, 1.9% to 24.9% in Training, 2.6% to 32.3% in Delivery, 5.2% to 44.3% in Receipt, and 6.7% to 43.2% in Enactment. The mean proportion of adherence to treatment fidelity strategies within each domain was: Design (68%), Training (14%), Delivery (15%), Receipt (16%), and Enactment (25%). Only 11 studies achieved ≥80% reporting across >1 fidelity domain. There was no evidence for improvement in fidelity reporting across the 13-year time frame from the initial BCC publication to the present. CONCLUSIONS: These findings illustrate the lack of consistency in fidelity reporting in tobacco treatment trials and underscore the challenges faced in evaluating rigor and reproducibility, as well as interpretation and dissemination of findings. Recommendations are made for improving fidelity reporting in tobacco treatment trials. IMPLICATIONS: The SRNT Treatment Research Network sponsored a scoping review to summarize the current state of reporting treatment fidelity and make recommendations for best practices in reporting fidelity in tobacco treatment trials. The review identified a lack of consistency in fidelity reporting, illustrating the challenges faced in evaluating rigor, and reproducibility, as well as interpretation and dissemination of findings.

Associations between cancer diagnosis and patients' responses to an inpatient tobacco treatment intervention.

BACKGROUND: Diagnosis of a chronic illness, such as cancer may influence health behavior changes, such as smoking cessation. The present analyses examine associations between a cancer diagnosis (i.e., yes or no) and response to an opt-out smoking cessation bedside intervention provided to hospitalized patients. It was hypothesized that patients with a past or present cancer diagnosis would report higher motivation and engagement with quitting smoking, and higher rates of smoking abstinence after hospital discharge, compared to those without a cancer diagnosis. METHODS: Chart review was conducted on 5287 inpatients who accepted bedside treatment from a counselor and opted-in to automated follow-up calls from July 2014 to December 2019. RESULTS: At the time of inpatient assessment, those with a past or present cancer diagnosis (n = 419, 7.9%) endorsed significantly higher levels of importance of quitting than those without a cancer diagnosis (3.92/5 vs. 3.77/5), and were more likely to receive smoking cessation medication upon discharge (17.9% vs. 13.3%). Follow-up data from 30-days post-discharge showed those with a cancer diagnosis endorsed higher rates of self-reported abstinence (20.5%) than those without a cancer diagnosis (10.3%; p < 0.001). CONCLUSION: Being hospitalized for any reason provides an opportunity for smokers to consider quitting. Having a previous diagnosis of cancer appears to increase intention to quit and lead to higher rates of smoking cessation in patients who are hospitalized compared to patients without cancer. Future research needs to work toward optimizing motivation for smoking cessation while admitted to a hospital and on improving quit rates for all admitted patients, regardless of diagnosis.

Preoperative contingency management intervention for smoking abstinence in cancer patients: trial protocol for a multisite randomised controlled trial.

INTRODUCTION: Continued smoking following a cancer diagnosis has substantial health risks including increased overall and cancer-specific mortality, risk of secondary malignancies, cancer treatment toxicity and risk of surgical complications. These risks can be mitigated by quitting smoking. The preoperative period represents a prime opportunity in which to administer robust smoking cessation treatment to both improve health and support and improve surgical outcomes. We will conduct a randomised clinical trial to evaluate the effectiveness of financial incentives delivered contingent on biochemically verified smoking abstinence (contingency management (CM)) in patients with cancer undergoing surgery. METHODS AND ANALYSIS: The study will take place across two study sites, and participants (N=282) who smoke, are diagnosed with or suspected to have any type of operable cancer and have a surgical procedure scheduled in the next 10 days to 5 weeks will be randomised to receive standard care plus Monitoring Only or CM prior to surgery. All patients will receive breath carbon monoxide (CO) tests three times per week, nicotine replacement therapy and counselling. The CM group will also earn payments for self-reported smoking abstinence confirmed by CO breath test ≤4 ppm on an escalating schedule of reinforcement (with a reset if they smoked). Point prevalence abstinence (PPA) outcomes (self-report of 7-day abstinence confirmed by CO≤4 ppm and/or anabasine ≤2 ng/mL) will be assessed on the day of surgery and 6 months after surgery. The effect of CM on 7-day PPA at the time of surgery and 6-month follow-up will be modelled using generalised linear mixed effects models. ETHICS AND DISSEMINATION: This study has been reviewed and approved by the Medical University of South Carolina Institutional Review Board. We will disseminate our scientific results through traditional research-oriented outlets such as presentations at scientific meetings and publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04605458.

Predictors of Enrollment of Older Smokers in Six Smoking Cessation Trials in the Lung Cancer Screening Setting: The Smoking Cessation at Lung Examination (SCALE) Collaboration.

SIGNIFICANCE: Increased rates of smoking cessation will be essential to maximize the population benefit of low-dose CT screening for lung cancer. The NCI's Smoking Cessation at Lung Examination (SCALE) Collaboration includes eight randomized trials, each assessing evidence-based interventions among smokers undergoing lung cancer screening (LCS). We examined predictors of trial enrollment to improve future outreach efforts for cessation interventions offered to older smokers in this and other clinical settings. METHODS: We included the six SCALE trials that randomized individual participants. We assessed demographics, intervention modalities, LCS site and trial administration characteristics, and reasons for declining. RESULTS: Of 6285 trial- and LCS-eligible individuals, 3897 (62%) declined and 2388 (38%) enrolled. In multivariable logistic regression analyses, Blacks had higher enrollment rates (OR 1.5, 95% CI 1.2,1.8) compared to Whites. Compared to "NRT Only" trials, those approached for "NRT + prescription medication" trials had higher odds of enrollment (OR 6.1, 95% CI 4.7,7.9). Regarding enrollment methods, trials using "Phone + In Person" methods had higher odds of enrollment (OR 1.6, 95% CI 1.2,1.9) compared to trials using "Phone Only" methods. Some of the reasons for declining enrollment included "too busy" (36.6%), "not ready to quit" (8.2%), "not interested in research" (7.7%), and "not interested in the intervention offered" (6.2%). CONCLUSION: Enrolling smokers in cessation interventions in the LCS setting is a major priority that requires multiple enrollment and intervention modalities. Barriers to enrollment provide insights that can be addressed and applied to future cessation interventions to improve implementation in LCS and other clinical settings with older smokers. IMPLICATIONS: We explored enrollment rates and reasons for declining across six smoking cessation trials in the lung cancer screening setting. Offering multiple accrual methods and pharmacotherapy options predicted increased enrollment across trials. Enrollment rates were also greater among Blacks compared to Whites. The findings offer practical information for the implementation of cessation trials and interventions in the lung cancer screening context and other clinical settings, regarding intervention modalities that may be most appealing to older, long-term smokers.