Factors associated with 60-day readmission among inpatients with COVID-19 at 21 United States health systems.

Identifying patients at risk for readmission after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection could facilitate care planning and prevention. This retrospective cohort study of 60-day readmission included 105 543 COVID-19 patients at 21 US healthcare systems who were discharged alive between February 2020 and November 2021. Generalized linear mixed regression analyses tested predictors of 60-day readmission and severity. The all-cause readmission rate was 15% (95% confidence interval [CI] = 10%-21%), with 22% (95% CI = 18%-26%) of readmitted patients needing intensive care, and 6% (95% CI = 05%-07%) dying. Factors associated with readmission included male sex, government insurance, positive smoking history, co-morbidity burden, longer index admissions, and diagnoses at index admission (e.g., cancer, chronic kidney disease, and liver disease). Death and intensive care rates at readmission declined postvaccine availability. Receiving at least two COVID-19 vaccine doses, which were more common among older patients and those with comorbid conditions, was not independently associated with readmission but predicted a reduced risk of death at readmission. This retrospective cohort study identified factors associated with all-cause readmission for patients re-admitted to the same health system after hospitalization with SARS-CoV-2 infection. Patients who are male, who smoke, who have a higher comorbidity burden, and have government insurance may benefit from additional postacute care planning.

The Relationship of COVID-19 Vaccination with Mortality Among 86,732 Hospitalized Patients: Subpopulations, Patient Factors, and Changes over Time.

BACKGROUND: Information on COVID-19 vaccination effects on mortality among patients hospitalized with COVID-19 could inform vaccination outreach efforts and increase understanding of patient risk. OBJECTIVE: Determine the associations of vaccination status with mortality in adult patients hospitalized with COVID-19. DESIGN: This retrospective cohort study assessed the characteristics and mortality rates of adult patients hospitalized with COVID-19 across 21 healthcare systems in the USA from January 1, 2021, to January 31, 2022. PARTICIPANTS: Adult patients admitted to participating hospitals who had COVID-19 diagnoses and/or positive PCR tests and completed their hospital stay via discharge or death. MAIN MEASURE: In-hospital mortality vs. discharge (outcome) and patient age, sex, race, ethnicity, BMI, insurance status, comorbidities, and vaccination status extracted from the electronic health record (EHR). KEY RESULTS: Of 86,732 adult patients hospitalized with COVID-19, 45,082 (52%) were female, mean age was 60 years, 20,800 (24%) were Black, and 22,792 (26.3%) had one or more COVID-19 vaccinations. Statistically adjusted mortality rates for unvaccinated and vaccinated patients were 8.3% (95% CI, 8.1-8.5) and 5.1% (95% CI, 4.8-5.4) respectively (7.9% vs. 4.5% with no immune compromise). Vaccination was associated with especially large reductions in mortality for obese (OR = 0.67; 95% CI 0.56-0.80) and severely obese (OR = 0.52; 95% CI, 0.41-0.67) patients and for older patients (OR = 0.99; 95% CI, 0.98-0.99). Mortality likelihood was higher later in the study period (August 2021-January 31, 2022) than earlier (January 1, 2021-July 30, 2021) (OR = 1.10; 95% CI = 1.04-1.17) and increased significantly for vaccinated patients from 4.6% (95% CI, 3.9-5.2%) to 6.5% (95% CI, 6.2-6.9%). CONCLUSIONS: Patients vaccinated for COVID-19 had reduced mortality, especially for obese/severely obese and older individuals. Vaccination's protective effect against mortality declined over time and hospitalized obese and older individuals may derive especially great benefit from prior vaccination against SARS-CoV-2.

Smoking Status, Nicotine Medication, Vaccination, and COVID-19 Hospital Outcomes: Findings from the COVID EHR Cohort at the University of Wisconsin (CEC-UW) Study.

INTRODUCTION: Available evidence is mixed concerning associations between smoking status and COVID-19 clinical outcomes. Effects of nicotine replacement therapy (NRT) and vaccination status on COVID-19 outcomes in smokers are unknown. METHODS: Electronic health record data from 104 590 COVID-19 patients hospitalized February 1, 2020 to September 30, 2021 in 21 U.S. health systems were analyzed to assess associations of smoking status, in-hospital NRT prescription, and vaccination status with in-hospital death and ICU admission. RESULTS: Current (n = 7764) and never smokers (n = 57 454) did not differ on outcomes after adjustment for age, sex, race, ethnicity, insurance, body mass index, and comorbidities. Former (vs never) smokers (n = 33 101) had higher adjusted odds of death (aOR, 1.11; 95% CI, 1.06-1.17) and ICU admission (aOR, 1.07; 95% CI, 1.04-1.11). Among current smokers, NRT prescription was associated with reduced mortality (aOR, 0.64; 95% CI, 0.50-0.82). Vaccination effects were significantly moderated by smoking status; vaccination was more strongly associated with reduced mortality among current (aOR, 0.29; 95% CI, 0.16-0.66) and former smokers (aOR, 0.47; 95% CI, 0.39-0.57) than for never smokers (aOR, 0.67; 95% CI, 0.57, 0.79). Vaccination was associated with reduced ICU admission more strongly among former (aOR, 0.74; 95% CI, 0.66-0.83) than never smokers (aOR, 0.87; 95% CI, 0.79-0.97). CONCLUSIONS: Former but not current smokers hospitalized with COVID-19 are at higher risk for severe outcomes. SARS-CoV-2 vaccination is associated with better hospital outcomes in COVID-19 patients, especially current and former smokers. NRT during COVID-19 hospitalization may reduce mortality for current smokers. IMPLICATIONS: Prior findings regarding associations between smoking and severe COVID-19 disease outcomes have been inconsistent. This large cohort study suggests potential beneficial effects of nicotine replacement therapy on COVID-19 outcomes in current smokers and outsized benefits of SARS-CoV-2 vaccination in current and former smokers. Such findings may influence clinical practice and prevention efforts and motivate additional research that explores mechanisms for these effects.

Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation: A Randomized Clinical Trial.

Importance: Smoking cessation medications are routinely used in health care. Research suggests that combining varenicline with the nicotine patch, extending the duration of varenicline treatment, or both, may increase cessation effectiveness. Objective: To compare combinations of varenicline plus the nicotine or placebo patch vs combinations used for either 12 weeks (standard duration) or 24 weeks (extended duration). Design, Settings, and Participants: Double-blind, 2 × 2 factorial randomized clinical trial conducted from November 11, 2017, to July 9, 2020, at 1 research clinic in Madison, Wisconsin, and at 1 clinic in Milwaukee, Wisconsin. Of the 5836 adults asked to participate in the study, 1251 who smoked 5 cigarettes/d or more were randomized. Interventions: All participants received cessation counseling and were randomized to 1 of 4 medication groups: varenicline monotherapy for 12 weeks (n = 315), varenicline plus nicotine patch for 12 weeks (n = 314), varenicline monotherapy for 24 weeks (n = 311), or varenicline plus nicotine patch for 24 weeks (n = 311). Main Outcomes and Measures: The primary outcome was carbon monoxide-confirmed self-reported 7-day point prevalence abstinence at 52 weeks. Results: Among 1251 patients who were randomized (mean [SD] age, 49.1 [11.9] years; 675 [54.0%] women), 751 (60.0%) completed treatment and 881 (70.4%) provided final follow-up. For the primary outcome, there was no significant interaction between the 2 treatment factors of medication type and medication duration (odds ratio [OR], 1.03 [95% CI, 0.91 to 1.17]; P = .66). For patients randomized to 24-week vs 12-week treatment duration, the primary outcome occurred in 24.8% (154/622) vs 24.3% (153/629), respectively (risk difference, -0.4% [95% CI, -5.2% to 4.3%]; OR, 1.01 [95% CI, 0.89 to 1.15]). For patients randomized to varenicline combination therapy vs varenicline monotherapy, the primary outcome occurred in 24.3% (152/625) vs 24.8% (155/626), respectively (risk difference, 0.4% [95% CI, -4.3% to 5.2%]; OR, 0.99 [95% CI, 0.87 to 1.12]). Nausea occurrence ranged from 24.0% to 30.9% and insomnia occurrence ranged from 24.4% to 30.5% across the 4 groups. Conclusions and Relevance: Among adults smoking 5 cigarettes/d or more, there were no significant differences in 7-day point prevalence abstinence at 52 weeks among those treated with combined varenicline plus nicotine patch therapy vs varenicline monotherapy, or among those treated for 24 weeks vs 12 weeks. These findings do not support the use of combined therapy or of extended treatment duration. Trial Registration: ClinicalTrials.gov Identifier: NCT03176784.

Anxiety Sensitivity and Distress Tolerance in Smokers: Relations With Tobacco Dependence, Withdrawal, and Quitting Success†.

INTRODUCTION: This study examined relations of two affective vulnerabilities, high anxiety sensitivity (AS) and low distress tolerance (DT), with tobacco dependence, withdrawal, smoking cessation, and pharmacotherapy response. METHODS: Smokers interested in quitting (N = 1067; 52.2% female, 28.1% African American) were randomized to 12 weeks of nicotine patch, nicotine patch plus nicotine lozenge, or varenicline. Baseline questionnaires assessed AS, DT, negative affect, anxiety, and dependence. Withdrawal was assessed the first-week post-quit via ecological momentary assessment. RESULTS: DT, but not AS, predicted biochemically confirmed point-prevalence abstinence at multiple endpoints: weeks 4, 12, 26, and 52 post-quit (ps < .05); relations remained after controlling for pharmacotherapy treatment, AS, baseline negative affect, anxiety, and anxiety disorder history (ps < .05). Additional exploratory analyses examining week 4 abstinence showed DT predicted abstinence (p = .004) even after controlling for baseline dependence, post-quit withdrawal (craving and negative affect), and treatment. DT moderated treatment effects on abstinence in exploratory analyses (interaction p = .025); those with high DT were especially likely to be abstinent at week 4 with patch plus lozenge versus patch alone. CONCLUSIONS: DT, but not AS, predicted abstinence over 1 year post-quit (higher DT was associated with higher quit rates), with little overlap with other affective measures. DT also predicted early abstinence independent of dependence and withdrawal symptoms. Results suggest low DT may play a meaningful role in motivation to use tobacco and constitute an additional affective risk factor for tobacco cessation failure beyond negative affect or clinical affective disorders. IMPLICATIONS: People in a stop-smoking study who reported a greater ability to tolerate distress were more likely to quit smoking and remain smoke-free 1 year later. Smokers with high DT were more likely to be smoke-free 4 weeks after their target quit day if they received nicotine patch plus nicotine lozenge rather than nicotine patch alone. TRIAL REGISTRATION: NCT01553084.

E-cigarette Dependence Measures in Dual Users: Reliability and Relations With Dependence Criteria and E-cigarette Cessation.

BACKGROUND: Electronic cigarettes (e-cigarettes) have drastically changed the nicotine and tobacco product landscape. However, their potential public health impact is still unclear. A reliable and valid measure of e-cigarette dependence would likely advance assessment and prognostication of the public health impact of e-cigarettes. The aim of this research was to examine the internal consistency, structure, and validity of three e-cigarette dependence scales. METHODS: Adult dual users (smokers who also vape, N = 256) enrolled in an observational cohort study (45.1% women, 70.7% white). At baseline, participants completed the e-cigarette Fagerström Test of Cigarette Dependence (e-FTCD), the e-cigarette Wisconsin Inventory of Smoking Dependence Motives (e-WISDM), and the Penn State Electronic Cigarette Dependence Index (PS-ECDI). All participants provided a urine sample for cotinine analysis and reported e-cigarette use at 1 year. RESULTS: The e-WISDM subscales had the highest internal consistency (α = .81-.96), then the PS-ECDI (α = .74) and e-FTCD (α = .51). A single-factor structure for the e-FTCD and an 11-factor structure for the e-WISDM were supported, but the PS-ECDI did not have a single-factor structure. All three e-cigarette dependence scales were highly correlated with validation criteria including continued e-cigarette use at 1 year, but not with e-liquid nicotine concentration or cotinine. CONCLUSIONS: The e-WISDM and PS-ECDI had stronger internal consistency than did the e-FTCD, despite the e-FTCD's single-factor structure, but all 3 measures appear to be valid measures of e-cigarette dependence as suggested by their significant relations with self-perceived addiction, heavy use, early use after overnight deprivation, and continued use over time. IMPLICATIONS: This research provides empirical support for three e-cigarette dependence measures: the e-FTCD, the PS-ECDI, and the e-WISDM among dual users of e-cigarettes and combustible cigarettes. The PS-ECDI and e-WISDM are more reliable, but all three measures were strongly correlated with key dependence constructs such as heavy use and continued use over time.

Electronically Monitored Nicotine Gum Use Before and After Smoking Lapses: Relationship With Lapse and Relapse.

INTRODUCTION: Greater use of nicotine replacement therapy (NRT) is related to smoking cessation success, but the causal direction is unclear. This study characterized the relationship between NRT use and smoking lapse and relapse. METHODS: Participants (N = 416 smokers; 57% female, 85% White) were recruited from primary care for a smoking cessation factorial experiment and analyzed if abstaining ≥1 day in the first 2 weeks post-target quit day (TQD). Participants were randomized to counseling and 8 versus 26 weeks of nicotine patch plus nicotine gum post-TQD. Participants carried electronic dispensers that timestamped each gum use. Participants who lapsed (smoked after abstaining) within 6 weeks post-TQD were matched with nonlapsers (n = 146 pairs) on multiple variables. We compared lapsers' versus matched nonlapsers' gum use in the 5 days before and after the lapsers' first lapse. RESULTS: By week 6 post-TQD, 63% of participants lapsed. Compared with nonlapsers, lapsers used less gum 1 and 2 days pre-"lapse" and on the 5 days post-lapse. Lapsers used less gum during the 5 days post-lapse than the 5 days pre-lapse. Univariate survival analyses with lapsers showed greater gum use during both pre- and post-lapse periods predicted longer latency to relapse in the first 6 weeks. CONCLUSIONS: In a smoking cessation attempt using nicotine patch plus gum, lapsers versus matched nonlapsers used less gum immediately preceding and following their first lapse. Lower mean gum use before and after lapses predicted a more rapid escalation to relapse. Decreased nicotine gum use both precedes and follows returns to smoking during cessation attempts. IMPLICATIONS: This research examined electronically monitored nicotine gum use collected in real time and found that among smokers engaged in a quit attempt, lapsers (vs. matched nonlapsers) tended to decrease their gum use 1-2 days prior to lapsing and to further decrease their gum use from pre- to post-lapse. Decreased gum use pre-lapse may signal heightened lapse risk in 1-2 days, with lower level of gum use predicting a more precipitous course of relapse. These results encourage further exploration of objective measures of smoking medication use patterns to examine their signaling properties and to inform understanding of cessation failure. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT01120704.

Financial incentives to Medicaid smokers for engaging tobacco quit line treatment: maximising return on investment.

BACKGROUND: Low-income smokers experience greater difficulty in quitting smoking than do other smokers. Providing financial incentives for treatment engagement increases smoking cessation success. This study models the cost-effectiveness of varying levels of financial incentives to maximise return on investment (ROI) for engaging low-income Medicaid recipients who smoke to take calls from a tobacco quit line. METHODS: Participants (N=1900) were recruited from May 2013 to June 2015 through quit line-based (n=980), clinic-based (n=444) or community-based referrals (n=476) into the Wisconsin Medicaid Quit Line Incentive project. Incentive (n=948) and control group participants (n=952) received $30 versus $0 per call, respectively, for taking up to five Wisconsin Tobacco Quit Line (WTQL) calls. Cost-effectiveness analyses estimated the incremental cost-effectiveness ratio for alternative financial incentives for engagement with WTQL calls. Probabilistic sensitivity analysis was employed to determine an optimal strategy for financial incentives to minimise the cost per individual who quit smoking. RESULTS: Using fixed payments, the incremental cost-effectiveness ratio of $2316 per smoker who quit in the randomised trial decreased to $2150 per smoker who quit when the incentives were modelled at $20 per each of five WTQL calls taken. Using variable payments, the minimal cost per additional smoker who quit was $2125 when incentives for the first four WTQL calls were set at $20, and the financial payment for the fifth WTQL call was set at $70. CONCLUSIONS: Modelling suggests that financial incentives in the amount of $20 per call for taking the first four quit line calls and $70 for taking a fifth quit line call maximise ROI to engage low-income smokers with evidence-based smoking cessation treatment.

Paying Low-Income Smokers to Quit? The Cost-Effectiveness of Incentivizing Tobacco Quit Line Engagement for Medicaid Recipients Who Smoke.

OBJECTIVES: To determine the cost-effectiveness of an incentive-based stop-smoking intervention that paid Medicaid recipients who smoke to take calls from a tobacco quit line. METHODS: A cost-effectiveness analysis was conducted alongside a randomized controlled trial. The analysis was conducted from a health care systems perspective on the basis of costs and effectiveness over a 6-month follow-up. Participants (n = 1900) were recruited from May 2013 to June 2015 through quit line (n = 980), clinic-based (n = 444), or community-based (n = 476) referrals. Incentive group participants (n = 948) received $30 a call for taking up to five tobacco quit line calls and $40 for biochemically verified tobacco abstinence at 6 months. Control group participants (n = 952) did not receive financial incentives for taking quit line calls. Intervention resource costs included incentive payments to participants, counselor and administrative staff time, and smoking cessation medications. Smoking status at baseline and 6 months was determined for all study participants via carbon monoxide (CO) breath tests (abstinence: CO < 7 ppm). Cost-effectiveness analysis calculated the incremental cost-effectiveness ratio (ICER). RESULTS: Incentive treatment produced higher 6-month CO-confirmed 7-day point-prevalence abstinence than did the control treatment (21.6 vs. 13.8%; P < 0.001). The ICER of the financial incentives intervention was $2316 (95% confidence interval $1582-$4270) per additional person who quit. The study ICER compares favorably with other smoking treatments, such as varenicline combined with proactive telephone counseling, whose ICER has been estimated at $2600 per additional smoker who quits. CONCLUSIONS: Use of financial incentives to engage with tobacco quit line treatment is a cost-effective option to enhance smoking cessation rates for low-income smokers.

Changes in carotid artery structure with smoking cessation.

Carotid artery grayscale ultrasound echogenicity and texture features predict cardiovascular disease events. We evaluated the longitudinal effects of smoking cessation on four grayscale ultrasound measures. This was a secondary analysis of data from 188 age, sex, and body mass index (BMI)-matched smokers (94 eventual abstainers [EA], 94 continued smokers [CS]) from a smoking cessation trial that had carotid ultrasound examinations at baseline and after 3 years. General linear models that included time, smoking group (EA or CS), and a time*smoking interaction term were used to examine the impact of smoking abstinence on carotid artery grayscale marker values at year 3. Participants were mean (SD) 50.3 (11.4) years old (57% female, 86% white). The baseline grayscale median value (GSM) was inversely correlated with age, BMI, insulin resistance, and smoking pack-years (r = -0.20 to -0.30, p < 0.007 for all). There was a significant time*smoking status interaction for predicting GSM at year 3: GSM decreased significantly in the EA group compared to the CS group (-3.63 [13.00] vs CS 0.39 [12.06] units; p = 0.029). BMI increased more in the EA than the CS group (2.42 [3.00] vs CS 0.35 [2.57] kg/m2; p < 0.001). After adjusting for changes in BMI, the time*smoking status interaction no longer was significant (p = 0.138). From baseline to year 3, contrast increased similarly in both groups. Entropy and angular second moment did not change significantly in either group. Changes in carotid ultrasound echogenicity and grayscale texture features during a smoking cessation attempt are modest and mostly related to weight gain. Clinicaltrials.gov Identifier: NCT01553084.

A Randomized Controlled Trial of an Optimized Smoking Treatment Delivered in Primary Care.

Background: The effectiveness of smoking cessation treatment is limited in real-world use, perhaps because we have not selected the components of such treatments optimally nor have treatments typically been developed for and evaluated in real-world clinical settings. Purpose: To validate an optimized smoking cessation treatment package that comprises intervention components identified as effective in factorial screening experiments conducted as per the Multiphase Optimization Strategy (MOST). Methods: Adult smokers motivated to quit were recruited from primary care clinics (N = 623). Participants were randomized to receive either recommended usual care (R-UC; 10 min of in-person counseling, 8 weeks of nicotine patch, and referral to quitline services) or abstinence-optimized treatment (A-OT; 3 weeks of prequit mini-lozenges, 26 weeks of nicotine patch + mini-lozenges, three in-person and eight phone counseling sessions, and 7-11 automated calls to prompt medication use). The key outcomes were self-reported and biochemically confirmed (carbon monoxide, CO <6 ppm) 7-day point-prevalence abstinence. Results: A-OT participants had significantly higher self-reported abstinence rates than R-UC participants at 4, 8, 16, and 26 weeks (ORs: 1.91-3.05; p <. 001). The biochemically confirmed 26-week abstinence rates were lower than the self-reported 26-week rates, but revealed a similar treatment effect size (OR = 2.94, p < .001). There was no moderation of treatment effects on 26-week abstinence by demographic, psychiatric, or nicotine dependence variables. A-OT had an incremental cost-effectiveness ratio for 26-week CO-confirmed abstinence of $7,800. Conclusions: A smoking cessation treatment that is optimized via MOST development meaningfully enhances cessation rates beyond R-UC smoking treatment in smokers seen in primary care. Clinical Trial Registration: NCT02301403.

Identifying Differences in Rates of Invitation to Participate in Tobacco Treatment in Primary Care.

INTRODUCTION: The progress achieved in reducing tobacco use has not been consistent across groups of smokers, and health systems are inconsistently implementing best practice guidelines. Guideline implementation could be associated with improved treatment invitation rates. AIMS: To evaluate differences in tobacco treatment invitation rates based on patient characteristics in primary care clinics implementing best practice guidelines. METHODS: A secondary analysis of patients presenting to 11 primary care clinics from 2 Wisconsin health systems from June 2010 to February 2013. The main outcome was whether patients received an invitation to participate in tobacco treatment. Invitation rates were examined by sex, age group (≤ 24 years, 25-44, 45-64, ≥ 64), race (white, black, other), insurance status (private, Medicare, Medicaid, none), and visit diagnosis ("high-risk" [cardiovascular and pulmonary disease, malignancy, pregnancy] vs "low-risk" [all other ICD-9 categories]). Moderation effects of health systems also were examined. RESULTS: Of the 95,471 patients seen, 84,668 (89%) were screened for smoking. Among the 15,193 smokers, 10,242 (67%) were invited to participate. Invited patients were older, white or black, and carried low-risk diagnoses. Invitation rates and patient-level differences varied between the health systems. CONCLUSIONS: Variable treatment invitation rates and health system differences remain evident in the primary care setting employing robust clinical practice guideline recommendations.

Offering smoking treatment to primary care patients in two Wisconsin healthcare systems: Who chooses smoking reduction versus cessation?

Smokers unwilling to make a quit attempt can still benefit from smoking intervention. However, it is unclear what proportion of smokers will enter such a Motivation phase intervention, and whether such an intervention attracts different types of smokers than does abstinence oriented treatment. We conducted a study from June 2010 to October 2013 based on a chronic care model of tobacco treatment among study eligible primary care patients (N=1579; 58% women, 89% White) presenting for regular health care visits in southern Wisconsin, U.S. Medical assistants, prompted via the electronic health record (EHR), invited smokers (n=10,242) to learn more about treatment options to help them either reduce their smoking or quit. Of those invited to learn more who were then reached by study staff, 10.2% (n=1046) reported interest in reduction treatment and 24% (n=2465) reported interest in cessation treatment. Patients who selected and ultimately entered reduction (n=492) versus cessation (n=1087) were more likely to report: older age; a history of anxiety; lower motivation to quit; lower primary dependence motives; more close friends or family who smoke; and a greater interval since their last quit attempt. Results suggest that Motivation phase treatment aimed at smoking reduction may increase the proportion and range of smokers inducted into tobacco treatment.

Effects of Nicotine Patch vs Varenicline vs Combination Nicotine Replacement Therapy on Smoking Cessation at 26 Weeks: A Randomized Clinical Trial.

IMPORTANCE: Smoking cessation medications are routinely used in health care; it is vital to identify medications that most effectively treat this leading cause of preventable mortality. OBJECTIVE: To compare the efficacies of varenicline, combination nicotine replacement therapy (C-NRT), and the nicotine patch for 26-week quit rates. DESIGN, SETTING, AND PARTICIPANTS: Three-group randomized intention-to-treat clinical trial occurring from May 2012 to November 2015 among smokers recruited in the Madison, Wisconsin, and Milwaukee, Wisconsin, communities; 65.5% of smokers offered the study (2687/4102) refused participation prior to randomization. INTERVENTIONS: Participants were randomized to one of three 12-week open-label smoking cessation pharmacotherapy groups: (1) nicotine patch only (n = 241); (2) varenicline only (including 1 prequit week; n = 424); and (3) C-NRT (nicotine patch + nicotine lozenge; n = 421). Six counseling sessions were offered. MAIN OUTCOMES AND MEASURES: The primary outcome was carbon monoxide-confirmed self-reported 7-day point-prevalence abstinence at 26 weeks. Secondary outcomes were carbon monoxide-confirmed self-reported initial abstinence, prolonged abstinence at 26 weeks, and point-prevalence abstinence at weeks 4, 12, and 52. RESULTS: Among 1086 smokers randomized (52% women; 67% white; mean age, 48 years; mean of 17 cigarettes smoked per day), 917 (84%) provided 12-month follow-up data. Treatments did not differ on any abstinence outcome measure at 26 or 52 weeks, including point-prevalence abstinence at 26 weeks (nicotine patch, 22.8% [55/241]; varenicline, 23.6% [100/424]; and C-NRT, 26.8% [113/421]) or at 52 weeks (nicotine patch, 20.8% [50/241]; varenicline, 19.1% [81/424]; and C-NRT, 20.2% [85/421]). At 26 weeks, the risk differences for abstinence were, for patch vs varenicline, -0.76% (95% CI, -7.4% to 5.9%); for patch vs C-NRT, -4.0% (95% CI, -10.8% to 2.8%); and for varenicline vs C-NRT, -3.3% (95% CI, -9.1% to 2.6%). All medications were well tolerated, but varenicline produced more frequent adverse events than did the nicotine patch for vivid dreams, insomnia, nausea, constipation, sleepiness, and indigestion. CONCLUSIONS AND RELEVANCE: Among adults motivated to quit smoking, 12 weeks of open-label treatment with nicotine patch, varenicline, or C-NRT produced no significant differences in biochemically confirmed rates of smoking abstinence at 26 weeks. The results raise questions about the relative effectiveness of intense smoking pharmacotherapies. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01553084.

Mindfulness training for smokers via web-based video instruction with phone support: a prospective observational study.

BACKGROUND: Many smokers are unable to access effective behavioral smoking cessation therapies due to location, financial limitations, schedule, transportation issues or other reasons. We report results from a prospective observational study in which a promising novel behavioral intervention, Mindfulness Training for Smokers was provided via web-based video instruction with telephone-based counseling support. METHODS: Data were collected on 26 low socioeconomic status smokers. Participants were asked to watch eight video-based classes describing mindfulness skills and how to use these skills to overcome various core challenges in tobacco dependence. Participants received eight weekly phone calls from a smoking cessation coach who provided general support and answered questions about the videos. On the quit day, participants received two weeks of nicotine patches. RESULTS: Participants were a mean of 40.5 years of age, smoked 16.31 cigarettes per day for 21.88 years, with a mean of 6.81 prior failed quit attempts. Participants completed a mean of 5.55 of 8 online video classes with a mean of 23.33 minutes per login, completed a mean of 3.19 of 8 phone coach calls, and reported a mean meditation practice time of 12.17 minutes per day. Smoking abstinence was defined as self-reported abstinence on a smoking calendar with biochemical confirmation via carbon monoxide breath-test under 7 parts per million. Intent-to-treat analysis demonstrated 7-day point prevalence smoking abstinence at 4 and 6-months post-quit of 23.1% and 15.4% respectively. Participants showed a significant pre- to post-intervention increase in mindfulness as measured by the Five-Factor Mindfulness Questionnaire, and a significant pre- to post-intervention decrease in the Anxiety Sub-scale of the Depression Anxiety and Stress Scale. CONCLUSIONS: Results suggest that Mindfulness Training for Smokers can be provided via web-based video instruction with phone support and yield reasonable participant engagement on intervention practices and that intervention efficacy and mechanism of effect deserve further study. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02164656 , Registration Date June 13, 2014.

Randomized trial on mindfulness training for smokers targeted to a disadvantaged population.

We report the results of a randomized trial comparing a novel smoking cessation treatment Mindfulness Training for Smokers (MTS) to a usual care therapy (Controls), which included the availability of a tobacco quit line and nicotine patches. Data were collected from 196 low socioeconomic status smokers in 2010-2011 in Madison, Wisconsin. Participants were randomized to either MTS or a telephonic quit line. The primary outcome was 6-month smoking abstinence measured by carbon monoxide breath testing and Time-Line Follow-Back. Among treatment initiators (randomized participants who participated in the intervention), abstinence rates were significantly different between the MTS (38.7%) and control (20.6%, p = .05) groups. Study limitations are also discussed. Results suggest that further study is warranted.

Culturally-Tailored Smoking Cessation for Adult American Indian Smokers: A Clinical Trial.

This collaborative, community-engaged project developed and tested a Culturally-Tailored Treatment (CTT) for American Indian/Alaska Native (AI/AN) smokers in the Menominee tribal community. One hundred three adult AI/AN smokers were randomized to receive either Standard Treatment (n= 53) or CTT (n = 50) for smoking cessation. Both treatment conditions included 12 weeks of varenicline and four individual counseling sessions but differed in terms of cultural tailoring of the counseling. The primary outcome was 7-day biochemically-confirmed point-prevalence abstinence (PPA) at the 6-month end-of-study visit. Both intention-to-treat (ITT) and responder-only analyses were conducted. There were no statistically significant group differences in 7-day PPA. The overall ITT abstinence rate at 6 months was 20%; the responder-only rate was 42%. The current study represents the first randomized smoking cessation clinical trial testing a culturally-tailored smoking cessation intervention designed for a specific AI/AN tribal community that combined FDA-approved cessation medication (varenicline) and innovative cultural intervention components.

What to do after smoking relapse? A sequential multiple assignment randomized trial of chronic care smoking treatments.

AIM: To compare effects of three post-relapse interventions on smoking abstinence. DESIGN: Sequential three-phase multiple assignment randomized trial (SMART). SETTING: Eighteen Wisconsin, USA, primary care clinics. PARTICIPANTS: A total of 1154 primary care patients (53.6% women, 81.2% White) interested in quitting smoking enrolled from 2015 to 2019; 582 relapsed and were randomized to relapse recovery treatment. INTERVENTIONS: In phase 1, patients received cessation counseling and 8 weeks nicotine patch. Those who relapsed and agreed were randomized to a phase 2 relapse recovery group: (1) reduction counseling + nicotine mini-lozenges + encouragement to quit starting 1 month post-randomization (preparation); (2) repeated encouragement to quit starting immediately post-randomization (recycling); or (3) advice to call the tobacco quitline (control). The first two groups could opt into phase 3 new quit treatment [8 weeks nicotine patch + mini-lozenges plus randomization to two treatment factors (skill training and supportive counseling) in a 2 × 2 design]. Phase 2 and 3 interventions lasted ≤ 15 months. MEASUREMENTS: The study was powered to compare each active phase 2 treatment with the control on the primary outcome: biochemically confirmed 7-day point-prevalence abstinence 14 months post initiating phase 2 relapse recovery treatment. Exploratory analyses tested for phase 3 counseling factor effects. FINDINGS: Neither skill training nor supportive counseling (each on versus off) increased 14-month abstinence rates; skills on versus off 9.3% (14/151) versus 5.2% (8/153), P = 0.19; support on versus off 6.6% (10/152) versus 7.9% (12/152), P = 0.73. Phase 2 preparation did not produce higher 14-month abstinence rates than quitline referral; 3.6% (8/220) versus 2.1% [3/145; risk difference = 1.5%, 95% confidence interval (CI) = -1.8-5.0%, odds ratio (OR) = 1.8, 95% CI = 0.5-6.9]. Recycling, however, produced higher abstinence rates than quitline referral; 6.9% (15/217) versus 2.1% (three of 145; risk difference, 4.8%, 95% CI = 0.7-8.9%, OR = 3.5, 95% CI = 1.0-12.4). Recycling produced greater entry into new quit treatment than preparation: 83.4% (181/217) versus 55.9% (123/220), P < 0.0001. CONCLUSIONS: Among people interested in quitting smoking, immediate encouragement post-relapse to enter a new round of smoking cessation treatment ('recycling') produced higher probability of abstinence than tobacco quitline referral. Recycling produced higher rates of cessation treatment re-engagement than did preparation/cutting down using more intensive counseling and pharmacotherapy.

Quitline cessation counseling for young adult smokers: a randomized clinical trial.

INTRODUCTION: One in 5 young adults in the United States currently smoke, and young adults are less likely than other smokers to make aided quit attempts. Telephone quitlines may be a useful tool for treating this population. This study tested a quitline-based smoking cessation intervention versus mailed self-help materials in smokers 18-24 years old. METHODS: This was a 2-group randomized clinical trial. The quitline-based counseling intervention (CI) included up to 4 proactive telephone counseling sessions; participants in the self-help (SH) group received only mailed cessation materials. Participants included 410 young adults who had smoked at least 1 cigarette in the past 30 days and who called the Wisconsin Tobacco Quit Line (WTQL) for help with quitting. Primary study outcomes included whether or not a quit date was set, whether or not a serious quit attempt was undertaken, and self-reported 7-day point-prevalence abstinence at 1-, 3-, and 6-month postenrollment. RESULTS: The CI and SH groups did not differ in the intent-to-treat abstinence analyses at any of the follow-ups. However, the CI group was significantly more likely to set a quit date at 1-month postenrollment. Follow-up response rates were low (67.8% at 1 month; 53.4% at 3 months; and 48.3% at 6 months) reflecting lower motivation to participate in this kind of research. CONCLUSIONS: Relative to self-help, quitline counseling motivated young adults to set a quit date but abstinence rates were not improved. Research is needed on how to motivate young adult smokers to seek cessation treatment including quitline services.

Enhancing tobacco quitline effectiveness: identifying a superior pharmacotherapy adjuvant.

INTRODUCTION: Telephone tobacco quitlines are effective and are widely used, with more than 500,000 U.S. callers in 2010. This study investigated the clinical effectiveness and cost-effectiveness of 3 different quitline enhancements: combination nicotine replacement therapy (NRT), longer duration of NRT, and counseling to increase NRT adherence. METHODS: In this study, 987 quitline callers were randomized to a combination of quitline treatments in a 2 × 2 × 2 factorial design: NRT duration (2 vs. 6 weeks), NRT type (nicotine patch only vs. patch plus nicotine gum), and standard 4-call counseling (SC) versus SC plus medication adherence counseling (MAC). The primary outcome was 7-day point-prevalence abstinence (PPA) at 6 months postquit in intention-to-treat (ITT) analyses. RESULTS: Combination NRT for 6 weeks yielded the highest 6-month PPA rate (51.6%) compared with 2 weeks of nicotine patch (38.4%), odds ratios [OR] = 1.71 (95% confidence interval [CI]:1.20-2.45). A similar result was found for 2 weeks of combination NRT (48.2%), OR = 1.49 (95% CI: 1.04-2.14) but not for 6 weeks of nicotine patch alone (46.2%), OR = 1.38 (95% CI: 0.96-1.97). The MAC intervention effect was nonsignificant. Cost analyses showed that the 2-week combination NRT group had the lowest cost per quit ($442 vs. $464 for 2-week patch only, $505 for 6-week patch only, and $675 for 6-week combination NRT). CONCLUSIONS: Combination NRT for 2 or 6 weeks increased 6-month abstinence rates by 10% and 13%, respectively, over rates produced by 2 weeks of nicotine patch when offered with quitline counseling. A 10% improvement would potentially yield an additional 50,000 quitters annually, assuming 500,000 callers to U.S. quitlines per year.