Physicians' Ratings of their Supervisor's Leadership Behaviors and Their Subsequent Burnout and Satisfaction: A Longitudinal Study.

OBJECTIVE: To evaluate the relationships between immediate supervisors' leadership qualities and the subsequent levels and changes in burnout and satisfaction of supervised physicians 2 years later. PARTICIPANTS AND METHODS: In 2015 and 2017 physicians were asked to complete surveys that included the 9-item Mayo Clinic Leadership Score (range, 9 to 45) assessing their supervisor, an item about satisfaction with the organization, and two items from the Maslach Burnout Inventory. Individual participants' responses to the surveys were linked. RESULTS: Among the 3698 physicians invited to complete both the 2015 and 2017 survey, 1795 (48.5%) responded. The mean composite baseline leadership score was 38.1 (SD, 8.4). Lower mean baseline leadership scores were reported by physicians who had burnout (mean [SD], 36.0 [9.7] vs 39.1 [7.3]; P<.001) 2 years later in comparison to those who did not have burnout 2 years later. In multivariable analysis, higher baseline leadership score of supervisors was independently associated with lower odds of physicians having burnout 2 years later (for each 1-point increase, odds ratio, 0.98; 95% CI, 0.96 to 0.99; P=.002) after adjusting for burnout at baseline, age, gender, length of service, and specialty. Baseline composite leadership score of supervisors was also independently associated with physicians' satisfaction with the organization 2 years later (odds ratio, 1.05; 95% CI, 1.03 to 1.07; P<.0001). CONCLUSION: Physicians' ratings of their immediate supervisors' leadership qualities were associated with their subsequent levels and changes in burnout and satisfaction 2 years later. Additional studies are needed to determine the effect of sharing such scores with immediate supervisors and providing additional leadership training to those with low scores, and if doing so ultimately reduces burnout and improves satisfaction of the supervised physicians.

Characterization of Nonphysician Health Care Workers' Burnout and Subsequent Changes in Work Effort.

Importance: Burnout is a pervasive, unrelenting problem among health care workers (HCWs), with detrimental impact to patients. Data on the impact of burnout on workforce staffing are limited and could help build a financial case for action to address system-level contributors to burnout. Objective: To explore the association of burnout and professional satisfaction with changes in work effort over 24 months in a large cohort of nonphysician HCWs. Design, Setting, and Participants: This longitudinal cohort study was conducted in Rochester, Minnesota; Scottsdale and Phoenix, Arizona; Jacksonville, Florida; and community-based hospitals and health care facilities in the Midwest among nonphysician HCWs who responded to 2 surveys from 2015 to 2017. Analysis was completed November 25, 2020. Exposures: Burnout, as measured by 2 items from the Maslach Burnout Inventory, and professional satisfaction. Main Outcomes and Measures: The main outcome was work effort, as measured in full-time equivalent (FTE) units, recorded in payroll records. Results: Data from 26 280 responders (7293 individuals aged 45-54 years [27.8%]; 20 263 [77.1%] women) were analyzed. A total of 8115 individuals (30.9%) had worked for the organization more than 15 years, and 6595 individuals (25.1%) were nurses. After controlling for sex, age, duration of employment, job category, baseline FTE, and baseline burnout, overall burnout (odds ratio [OR], 1.53; 95% CI, 1.38-1.70; P < .001), high emotional exhaustion at baseline (OR, 1.54; 95% CI, 1.39-1.71; P < .001), and high depersonalization at baseline (OR, 1.40; 95% CI, 1.21-1.62; P < .001) were associated with an HCW reducing their FTE over the following 24 months. Conversely, satisfaction with the organization at baseline was associated with lower likelihood of reduced FTE (OR, 0.73; 95% CI, 0.65-0.83; P < .001). Findings were similar when emotional exhaustion (OR per 1-point increase, 1.12; 95% CI, 1.10-1.16; P < .001), depersonalization (OR per 1-point increase, 1.10; 95% CI, 1.06-1.14; P < .001) and satisfaction with the organization (OR per 1-point increase, 0.83; 95% CI, 0.79-0.88; P < .001) were modeled as continuous measures. Nurses represented the largest group (1026 of 1997 nurses [51.4%]) reducing their FTE over the 24 months. Conclusions and Relevance: This cohort study found that burnout and professional satisfaction of HCWs were associated with subsequent changes in work effort over the following 24 months. These findings highlight the importance of addressing factors contributing to high stress among all HCWs as a workforce retention and cost reduction strategy.

The Association of Current Tobacco Status With Pain and Symptom Severity in Fibromyalgia Patients.

OBJECTIVE: To describe current tobacco use among patients with newly confirmed fibromyalgia and evaluate the association between tobacco use status and severity of reported pain and other fibromyalgia symptoms. PATIENTS AND METHODS: Participants in this study were adult patients (N=1068) with fibromyalgia who met American College of Rheumatology 2010/2011 clinical criteria for fibromyalgia at the time of initial presentation to a Midwest fibromyalgia clinic (June 1, 2018, through May 31, 2019). Multiple linear regression analyses were performed to assess the association of tobacco use status with the Widespread Pain Index (WPI) and Symptom Severity Scale (SSS) scores. Covariates included in these analyses included age, sex, body mass index, depression, opioid medication use, and use of fibromyalgia-specific pharmacotherapy. RESULTS: The patients were largely women (87.0%; n=929), white (87.9%; n=939), and with an average ± SD age of 46.6±13.9 years. The WPI and SSS scores were significantly greater in current tobacco users compared with never tobacco users (WPI effect estimate [EE] = 1.03; 95% CI, 0.30 to 1.76; type III P=.020; SSS EE = 0.47; 95% CI, 0.11 to 0.84; type III P=.036). The WPI score was negatively associated with age (EE = -0.02 per year; 95% CI, -0.03 to -0.001 per year; P=.037) and no use of opioid medication (EE = -1.08; 95% CI, -1.59 to -0.57; P<.001) while positively associated with higher body mass index (EE = 0.03 per 1 kg/m2; 95% CI, 0.001 to 0.06 per kg/m2; P=.04) and higher Patient Health Questionnaire-9 score (EE = 0.12; 95% CI, 0.08 to 0.16; P<.001). CONCLUSION: The results of our study suggest that tobacco use is associated with greater pain and other symptom severity in patients with fibromyalgia. These findings have important clinical and research implications for patients with fibromyalgia who use tobacco and who may benefit from early identification and timely implementation of tobacco cessation treatment to decrease pain and improve overall quality of life.

Frequently Reported Adverse Events With Smoking Cessation Medications: Post Hoc Analysis of a Randomized Trial.

OBJECTIVE: To compare the incidence, severity, and clinical course of frequently reported adverse events (AEs) after treatment with smoking cessation pharmacotherapies. METHODS: This was a multinational, multicenter, post hoc analysis of frequently reported treatment-emergent AEs from a large, phase 4, double-blind, randomized, triple-dummy, placebo-controlled trial (EAGLES), conducted between November 30, 2011, and January 13, 2015, that included smokers with and without psychiatric disorders (N=8144). Treatments were varenicline 1 mg twice daily, bupropion sustained-release 150 mg twice daily, and nicotine patch 21 mg once daily with tapering (12-week treatment, 12-week nontreatment follow-up), with incidence, time to onset, and duration of frequently reported AEs (≥5% of participants in any treatment group) measured. Risk differences for AEs for varenicline and bupropion vs nicotine patch were compared. RESULTS: Across frequently reported AEs, nausea, insomnia, abnormal dreams, anxiety, irritability, dry mouth, fatigue, and application site pruritus differed significantly in active treatment vs placebo groups. Risk differences were as follows: for nausea with varenicline vs nicotine patch, 15.50% (95% CI, 13.20% to 17.80%); for insomnia with bupropion vs nicotine patch, 2.58% (CI, 0.65% to 4.51%); and for abnormal dreams with varenicline and bupropion vs nicotine patch, -2.49% (CI, -4.35% to -0.64%) and -5.60% (CI, -7.27% to -3.93%), respectively. Frequently reported AEs of severe intensity and treatment discontinuation were experienced by less than 1.5% and less than 3% of participants across all groups, respectively. CONCLUSION: Active treatments were well tolerated with comparable AE profiles. Most AEs are not clinically important, and prescribers can reassure patients that those experienced will be manageable. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01456936.

Electronic Cigarette Use Is Not Associated with COVID-19 Diagnosis.

This analysis tested the hypothesis that current e-cigarette use was associated with an increased risk of SARS-CoV-2 infection in patients seeking medical care. E-cigarette and conventional cigarette use were ascertained using a novel electronic health record tool, and COVID-19 diagnosis was ascertained by a validated institutional registry. Logistic regression models were fit to assess whether current e-cigarette use was associated with an increased risk of COVID-19 diagnosis. A total of 69,264 patients who were over the age of 12 years, smoked cigarettes or vaped, and were sought medical care at Mayo Clinic between September 15, 2019 and November 30, 2020 were included. The average age was 51.5 years, 62.1% were females and 86.3% were white; 11.1% were currently smoking cigarettes or using e-cigarettes and 5.1% tested positive for SARS-CoV-2. Patients who used only e-cigarettes were not more likely to have a COVID-19 diagnosis (OR 0.93 [0.69-1.25], P = .628), whereas those who used only cigarettes had a decreased risk (OR 0.43 [0.35-0.53], P < .001). The OR for dual users fell between these 2 values (OR 0.67 [0.49-0.92], P = .013). Although e-cigarettes have the well-documented potential for harm, they do not appear to increase susceptibility to SARS-CoV-2 infection. This result suggests the hypothesis that any beneficial effects of conventional cigarette smoking on susceptibility are not mediated by nicotine.

Improved Documentation of Electronic Cigarette Use in an Electronic Health Record.

The use of electronic cigarettes (e-cigarettes) can affect patient health and clinical care. However, the current documentation of e-cigarette use in the electronic health records (EHR) is inconsistent. This report outlines how the ambulatory clinical practices of a large U.S. hospital system optimized its electronic health records (EHR) framework to better record e-cigarettes used by patients. The new EHR section for e-cigarette information was implemented for outpatient appointments. During a 30-week evaluation period post-implementation, 638,804 patients (12 yrs and older) completed ambulatory appointments within the health system; of these, the new section contained e-cigarette use information for 37,906 (6%) patients. Among these patients, 1005 (2.7%) were identified as current e-cigarette users (current every day or current some day e-cigarette use), 941 (2.5%) were reported as former e-cigarette users, and 35,960 (94%) had never used e-cigarettes. A separate EHR section to document e-cigarette use is feasible within existing clinical practice models. Utilization of the new section was modest in routine clinical practice, indicating the need for more intensive implementation strategies that emphasize the health effects of e-cigarette use, and how consistent ascertainment could improve clinical practice.

Design and Pilot Implementation of an Electronic Health Record-Based System to Automatically Refer Cancer Patients to Tobacco Use Treatment.

Continued tobacco use after cancer diagnosis is detrimental to treatment and survivorship. The current reach of evidence-based tobacco treatments in cancer patients is low. As a part of the National Cancer Institute Cancer Center Cessation Initiative, the Mayo Clinic Cancer Center designed an electronic health record (EHR, Epic©)-based process to automatically refer ambulatory oncology patients to tobacco use treatment, regardless of intent to cease tobacco use("opt out"). The referral and patient scheduling, accomplished through a best practice advisory (BPA) directed to staff who room patients, does not require a co-signature from clinicians. This process was piloted for a six-week period starting in July of 2019 at the Division of Medical Oncology, Mayo Clinic, Rochester, MN. All oncology patients who were tobacco users were referred for tobacco treatment by the rooming staff (n = 210). Of these, 150 (71%) had a tobacco treatment appointment scheduled, and 25 (17%) completed their appointment. We conclude that an EHR-based "opt-out" approach to refer patients to tobacco dependence treatment that does not require active involvement by clinicians is feasible within the oncology clinical practice. Further work is needed to increase the proportion of scheduled patients who attend their appointments.

Relationship Between Organizational Leadership and Health Care Employee Burnout and Satisfaction.

OBJECTIVE: To explore the relationship between immediate supervisor leadership behaviors and burnout and professional satisfaction of health care employees. PARTICIPANTS AND METHODS: From October 2 to 20, 2017, we surveyed nonphysician health care employees. The survey included 2 items from the Maslach Burnout Inventory and items on their immediate supervisor leadership behaviors. Logistic regression was performed to evaluate the relationship between the leadership score and the prevalence of burnout and satisfaction after adjusting for age, sex, duration of employment, and job category. Sensitivity analysis was performed using mixed models with a random intercept for work unit to assess the impact of the correlation within work units on burnout and satisfaction with the organization. RESULTS: Of the 57,414 employees surveyed, 39,896 (69.5%) responded and answered the leadership questions. Supervisor scores in each dimension and composite leadership scores correlated with burnout and satisfaction of employees (P<.001 for all). In logistic regression, each 1-point increase in leadership score was associated with a 7% decrease in odds of burnout and an 11% increase in odds of satisfaction (P<.001 for both) of employees. The mean composite leadership score rating of each immediate supervisor correlated with rate of burnout (r=-0.247; P<.001) and the satisfaction with the organization (r=0.416; P<.001) at the work unit level. CONCLUSION: Leadership qualities of immediate supervisors relate to burnout and satisfaction of nonphysician health care employees working in a large organization. Further studies are needed to determine whether strategies to monitor and improve supervisor leadership scores result in reduction in burnout and improved satisfaction among health care employees.

VpALI-Vaping-related Acute Lung Injury: A New Killer Around the Block.

The use of electronic cigarettes, known as vaping, has become increasingly popular over the past decade, particularly in the adolescent and young adult population, often exposing users to harmful chemicals. Vaping has been associated with a heterogeneous group of pulmonary disease. Recently, a multistate epidemic has emerged surrounding vaping-related acute lung injury, prompting the Centers for Disease Control and Prevention to list an official health advisory. In this review, we describe the current literature on the epidemiology, clinical significance, as well as recommended evaluation and treatment of vaping-related lung injury.

Tobacco Dependence Treatment Grants: A Collaborative Approach to the Implementation of WHO Tobacco Control Initiatives.

The number of global tobacco-related deaths is projected to increase from about 6 million to 8 million annually by 2030, with more than 80% of these occurring in low- and middle-income countries (LMICs). The World Health Organization Framework Convention on Tobacco Control (FCTC) came into force in 2005 and Article 14 relates specifically to the treatment of tobacco dependence. However, LMICs, in particular, face several barriers to implementing tobacco dependence treatment. This paper is a descriptive evaluation of a novel grant funding mechanism that was initiated in 2014 to address these barriers. Global Bridges. Healthcare Alliance for Tobacco Dependence Treatment aims to create and mobilize a global network of healthcare professionals and organizations dedicated to advancing evidence-based tobacco dependence treatment and advocating for effective tobacco control policy. A 2014 request for proposals (RFP) focused on these goals, particularly in LMICs, where funding for this work had been previously unavailable. 19 grants were awarded by Global Bridges to organizations in low- and middle-income countries across all six WHO regions. Virtually all focused on developing a tobacco dependence treatment curriculum for healthcare providers, while also influencing the political environment for Article 14 implementation. As a direct result of these projects, close to 9,000 healthcare providers have been trained in tobacco dependence treatment and an estimated 150,000 patients have been offered treatment. Because most of these projects are designed with a "train-the-trainer" component, two years of grant funding has been a tremendous catalyst for accelerating change in tobacco dependence treatment practices throughout the world. In order to foster such exponential growth and continue to maintain the impact of these projects, ongoing financial, educational, and professional commitments are required.

Cardiovascular Safety of Varenicline, Bupropion, and Nicotine Patch in Smokers: A Randomized Clinical Trial.

Importance: Quitting smoking is enhanced by the use of pharmacotherapies, but concerns have been raised regarding the cardiovascular safety of such medications. Objective: To compare the relative cardiovascular safety risk of smoking cessation treatments. Design, Setting, and Participants: A double-blind, randomized, triple-dummy, placebo- and active-controlled trial (Evaluating Adverse Events in a Global Smoking Cessation Study [EAGLES]) and its nontreatment extension trial was conducted at 140 multinational centers. Smokers, with or without established psychiatric diagnoses, who received at least 1 dose of study medication (n = 8058), as well as a subset of those who completed 12 weeks of treatment plus 12 weeks of follow up and agreed to be followed up for an additional 28 weeks (n = 4595), were included. Interventions: Varenicline, 1 mg twice daily; bupropion hydrochloride, 150 mg twice daily; and nicotine replacement therapy, 21-mg/d patch with tapering. Main Outcomes and Measures: The primary end point was the time to development of a major adverse cardiovascular event (MACE: cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) during treatment; secondary end points were the occurrence of MACE and other pertinent cardiovascular events (MACE+: MACE or new-onset or worsening peripheral vascular disease requiring intervention, coronary revascularization, or hospitalization for unstable angina). Results: Of the 8058 participants, 3553 (44.1%) were male (mean [SD] age, 46.5 [12.3] years). The incidence of cardiovascular events during treatment and follow-up was low (<0.5% for MACE; <0.8% for MACE+) and did not differ significantly by treatment. No significant treatment differences were observed in time to cardiovascular events, blood pressure, or heart rate. There was no significant difference in time to onset of MACE for either varenicline or bupropion treatment vs placebo (varenicline: hazard ratio, 0.29; 95% CI, 0.05-1.68 and bupropion: hazard ratio, 0.50; 95% CI, 0.10-2.50). Conclusions and Relevance: No evidence that the use of smoking cessation pharmacotherapies increased the risk of serious cardiovascular adverse events during or after treatment was observed. The findings of EAGLES and its extension trial provide further evidence that smoking cessation medications do not increase the risk of serious cardiovascular events in the general population of smokers. Trial Registration: clinicaltrials.gov Identifier: NCT01574703.

Varenicline for tobacco-dependence treatment in alcohol-dependent smokers: A randomized controlled trial.

BACKGROUND: Tobacco use is prevalent among persons with alcohol abuse and dependence. Varenicline has been shown to be the most effective pharmacotherapy for smoking cessation and may decrease alcohol consumption. The purpose of this study was to evaluate the efficacy of 12 weeks of varenicline for increasing smoking abstinence rates in smokers with alcohol abuse or dependence. METHODS: Participants were eligible for enrollment if they were 18 years or older, smoked 10 or more cigarettes per day for at least 6 months, had current alcohol abuse or dependence, and were interested in quitting smoking. Participants were randomly assigned to receive 12 weeks of varenicline 1 mg twice daily or matching placebo. The primary end point was 7-day point prevalence smoking abstinence at week 12. RESULTS: The 7-day point prevalence smoking abstinence rate at 12 weeks was significantly higher with varenicline (n = 16) than placebo (n = 17) (43.8% vs 5.9%; P = .01). At 24 weeks, the 7-day point prevalence smoking abstinence rate was still significantly higher with varenicline than placebo (31.3% vs 0%; P = .02). At 12 weeks, mean (SD) drinks per drinking day was significantly lower with varenicline than placebo (5.7 [3.9] vs 9.0 [5.3] drinks; treatment effect estimate, -2.8 [90% CI, -6.6 to -1.0]). Adverse events were minor and comparable to varenicline clinical trials. CONCLUSIONS: Varenicline is safe and efficacious for increasing smoking abstinence rates in smokers with alcohol abuse or dependence. Varenicline may decrease alcohol consumption in this population of smokers.

An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial.

BACKGROUND: Delivering effective tobacco dependence treatment that is feasible within lung cancer screening (LCS) programs is crucial for realizing the health benefits and cost savings of screening. Large-scale trials and systematic reviews have demonstrated that digital cessation interventions (i.e. web-based and text message) are effective, sustainable over the long-term, scalable, and cost-efficient. Use of digital technologies is commonplace among older adults, making this a feasible approach within LCS programs. Use of cessation treatment has been improved with models that proactively connect smokers to treatment rather than passive referrals. Proactive referral to cessation treatment has been advanced through healthcare systems changes such as modifying the electronic health record to automatically link smokers to treatment. METHODS: This study evaluates the impact of a proactive enrollment strategy that links LCS-eligible smokers with an evidence-based intervention comprised of a web-based (WEB) program and integrated text messaging (TXT) in a three-arm randomized trial with repeated measures at one, three, six, and 12 months post randomization. The primary outcome is biochemically confirmed abstinence at 12 months post randomization. We will randomize 1650 smokers who present for a clinical LCS to: (1) a usual care control condition (UC) which consists of Ask-Advise-Refer; (2) a digital (WEB + TXT) cessation intervention; or (3) a digital cessation intervention combined with tobacco treatment specialist (TTS) counseling (WEB + TXT + TTS). DISCUSSION: The scalability and sustainability of a digital intervention may represent the most cost-effective and feasible approach for LCS programs to proactively engage large numbers of smokers in effective cessation treatment. We will also evaluate the impact and cost-effectiveness of adding proven clinical intervention provided by a TTS. We expect that a combined digital/clinical intervention will yield higher quit rates than digital alone, but that it may not be as cost-effective or feasible for LCS programs to implement. This study is innovative in its use of interoperable, digital technologies to deliver a sustainable, scalable, high-impact cessation intervention and to facilitate its integration within clinical practice. It will add to the growing knowledge base about the overall effectiveness of digital interventions and their role in the healthcare delivery system. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03084835 . Registered on 9 March 2017.

Implementing evidence-based smoking cessation treatment in psychosocial care units (CAPS) in Brazil.

BACKGROUND: The prevalence of smoking among mental health and addiction (MHA) patients is 3 times higher than it is in the general population, yet this patient population has received little help to combat smoking. Considering this, psychosocial care centers (CAPS - Centros de Atenção Psicossocial) are strategic locations for integrating tobacco dependence treatment (TDT) into existing treatment activities. METHODS: Our team provided an 8-hour training package to the staff of CAPS that have not been providing specialized TDT for smokers. Our curriculum included the following topics focused on the implementation of treatment for MHA smokers: management, epidemiology, medications, psychotherapy, and smoking/mental health assessment instruments. RESULTS: Our team trained the staff of 17 CAPS units within 10 cities - which included more than 186 health professionals. There were many barriers encountered as we provided this training. A summary of problems we faced were as follows: resistance to incorporating TDT in addiction/mental health-care units, resistance to the implementation of cognitive-behavioral therapy (CBT) (psychodynamic therapy and harm reduction were preferred) and treatment for smoking is already implemented in primary care network; resistance to the use of medication in addiction treatment (a preference for psychotherapy and psychosocial approach). CONCLUSION: We learned a number of important lessons as we worked to improve the delivery of TDT to MHA patients in Brazil: provide clinicians an opportunity to explore how they feel/think about providing TDT to their clients at the very outset of the training, rather than focusing on a specific type of behavioral therapy for TDT (such as CBT), which some may find objectionable; use more generic descriptions of behavioral therapy such as 'supportive counseling'; include training professionals who are open to other forms of behavioral therapy in addition to psychoanalysis and discuss the important impact that MHA units can have in improving the quality of life for their patients who smoke.

Beliefs, Practices, and Self-efficacy of US Physicians Regarding Smoking Cessation and Electronic Cigarettes: A National Survey.

INTRODUCTION: We sought to assess physician knowledge/beliefs, self-efficacy, and experience/practice patterns surrounding smoking cessation and electronic cigarettes. METHODS: An eight-page survey sent via US Postal service. The initial invitation included a $10 cash incentive and up to three invitations were sent. Fifteen hundred US physicians were identified with equal representation from primary care physicians (internal medicine and family practice), surgical care physicians (general surgeons and anesthesiologists), and pulmonologists. RESULTS: Two hundred fourteen were not included in the analysis (183 non-deliverable, one deceased, 30 not practicing). 561/1286 (44%) remaining surveys were returned for analysis. Greater than 90% agreed that advising and assisting with smoking cessation is their responsibility; 86% advise and 65% assist their patients with smoking cessation more than 75% of the time. Approximately two-thirds of respondents report that their patients ask them about electronic cigarettes at least some of the time (≥25%); 58.4% report that they ask their patients about electronic cigarette use at least some of the time. Overall, 37.9% have at some point recommended electronic cigarettes to their patients that smoke, with 11.5% reporting recommending them at least 25% of the time. Surgical care providers appear less confident and less self-efficacious with smoking cessation, as well as with electronic cigarettes and appear less likely to endorse use of electronic cigarettes. DISCUSSION: US physicians are frequently discussing electronic cigarettes in a clinical context and a substantial proportion of US physicians have recommended electronic cigarettes to their patients. IMPLICATIONS: This study documents several important previously poorly characterized aspects of the role of electronic cigarettes in clinical care. The majority of US physicians are discussing electronic cigarettes in clinical contexts and a substantial proportion of US physicians have recommended electronic cigarettes to their patients. The extent of physician engagement on the topic of electronic cigarettes should be met with increased efforts to better characterize electronic cigarettes' appropriate role in smoking cessation and reduction.

Combination Varenicline and Lorcaserin for Tobacco Dependence Treatment and Weight Gain Prevention in Overweight and Obese Smokers: A Pilot Study.

INTRODUCTION: Post-cessation weight gain (PCWG) is a major barrier to maintaining abstinence, especially in weight-concerned smokers. Varenicline is the most effective medication for smoking cessation but has minimal impact on PCWG. Lorcaserin is an FDA-approved medication for weight management in overweight or obese patients which also provides a noticeable benefit in treating drug dependence. We hypothesized that combining varenicline with lorcaserin may help prevent PCWG. We conducted an open-label, single arm, Phase II clinical pilot study to obtain preliminary data on the safety and effectiveness of combination varenicline and lorcaserin in preventing PCWG in overweight and obese smokers. METHODS: Twenty overweight or obese (body mass index 27-40 kg/m2) cigarette smokers were enrolled. The primary outcomes were weight and waist circumference (WC) changes at 12 and 26 weeks in smokers meeting criteria for prolonged smoking abstinence. All participants received open-label varenicline (1 mg twice a day) and lorcaserin (10 mg twice a day) for 12 weeks with follow-up at 26 weeks. RESULTS: Ten subjects met criteria for prolonged smoking abstinence at 12 weeks (50%) and 6 at 26 weeks (30%). Among those achieving prolonged smoking abstinence at 12 weeks, WC was +0.2 ± 6.0 cm (90% CI; -2.9, +3.4) and weight gain was +1.1 ± 3.9 kg (90% CI; -0.9, +3.1). CONCLUSIONS: Weight gain and WC increases following prolonged smoking abstinence may be reduced among overweight and obese smokers using combination varenicline and lorcaserin. This combinatory treatment warrants further research in the obese and weight-concerned smoking population. IMPLICATIONS: This is the first published prospective pilot study to evaluate lorcaserin for use in reducing PCWG in overweight and obese smokers. When combined with varenicline, lorcaserin minimized PCWG and increases in WC. In addition to the benefit on PCWG reduction, lorcaserin may be a potential new pharmacological treatment for smoking cessation and warrants further larger studies.