About

Frank Thomas Leone, MD, MS, is a Professor of Medicine specializing in Pulmonary, Allergy, and Critical Care at the Hospital of the University of Pennsylvania. He serves as the Director of the Comprehensive Smoking Treatment Program at the University of Pennsylvania and is a Senior Fellow at the Leonard Davis Institute of Health Economics at the Wharton School. Dr. Leone is a member of the Abramson Cancer Center's Tobacco & Environmental Carcinogenesis Program. His research expertise includes tobacco dependence treatment strategies, smoking cessation, physician training, physician decision-making, and behavioral economics. His clinical expertise encompasses tobacco smoking cessation, nicotine dependence, tobacco use treatment systems-based interventions, and tobacco use treatment training programs for healthcare providers. Dr. Leone's educational background includes a B.A. in Biology from Hofstra University, graduate studies in Pharmacology at the University of Pennsylvania, an M.D. from the University of Pittsburgh School of Medicine, and an M.S. in Clinical Epidemiology from the University of Pennsylvania.

Research topics

• Medicine
• Anesthesia
• Environmental health
• Psychology

Selected publications

• Text-Message Outreach to Connect Adolescents and Young Adults to Nicotine Treatment: A Pilot Study in Pediatric Primary Care

  Academic Pediatrics · 2026-04-10

  articleOpen access

  OBJECTIVE: Strategies are needed to increase adolescent and young adult (AYA) engagement in nicotine use treatment. We assessed feasibility, acceptability, and clinical impact of text-message outreach connecting AYA to nicotine use treatment across a large health network. METHODS: This quality improvement pilot study included 2 phases of text-message outreach following primary care visits. All patients aged 13 to 22 completed an in-visit confidential electronic health questionnaire assessing past 30-day nicotine use. Phase 1: patients selected whether to receive text outreach about quitting resources. Phase 2: all patients reporting nicotine use who provided a phone number on the electronic questionnaire received automatic text outreach. Treatment options included a text-messaging program (This is Quitting) and/or nicotine replacement therapy. Outcome measures included feasibility (phone number provision), acceptability (treatment interest), and clinical impact (treatment connection). RESULTS: Among 23,411 AYA screened from February to June 2024, 919 (3.9%) reported past 30-day nicotine use. For feasibility, 90% and 91% of AYA who reported nicotine use provided a phone number in each phase, respectively. Acceptability was higher in Phase 1 versus Phase 2 (11% vs 2%), but clinical impact was similar (2% vs 1%). Overall, 824 patients who reported nicotine use provided a phone number (90%), 59 expressed treatment interest (6%), and 16 connected to treatment (2%). CONCLUSIONS: Text-message outreach was feasible but achieved low acceptability and clinical impact. Barriers included a high rate of messages blocked as spam, limited interventions for AYA with infrequent nicotine use, and barriers to accessing NRT related to cost and confidentiality.

  PublisherOA PDFDOI

• Differences in Cognition and Smoking Abstinence Rates Among People With and Without HIV Who Smoke

  Nicotine & Tobacco Research · 2025-06-27 · 1 citations

  articleOpen access

  INTRODUCTION: High rates of smoking among people with HIV (PWH) persist and may be due to HIV-associated neurocognitive disorders exacerbating abstinence-induced cognitive deficits, leading to higher risk of relapse. This study assessed differences in smoking abstinence rates and abstinence-induced cognitive deficits among PWH and people without (PWOH). METHODS: In this prospective observational design (NCT03169101), treatment-seeking adults completed two laboratory sessions during a pre-quit phase to assess cognition: once following 24h abstinence and once smoking-as-usual. Cognition was measured through response inhibition, working memory, and verbal memory tasks. All received standard smoking cessation treatment over 8 weeks (i.e., counseling, nicotine patch). Point-prevalence abstinence was assessed at end-of-treatment. RESULTS: Our sample included 210 participants (38.1% PWH; 61.9% PWOH), who were mostly male (59.5%) and Black/African-American (76.7%). No significant HIV status by abstinence condition interactions emerged for any cognitive outcome (all ps > .4). There were significant abstinence-induced deficits in response inhibition (p = .02), working memory response time (p = .005), and verbal memory (p=<.001). No significant differences emerged in abstinence rates between PWH and PWOH (31.2%, 32.3%, respectively; OR = 1.26, 95% CI: 0.67, 2.39, p = .48). CONCLUSION: Despite prior research suggesting differences in abstinence rates and cognition between PWH and PWOH who smoke, hypotheses were not supported. However, this is one of a few studies to directly compare people with and without HIV in a rigorously designed mechanistic smoking cessation study. Given that cognition does not appear to play a primary role in smoking among PWH, more work is needed to understand the mechanisms driving disproportionate smoking rates among PWH.

  PublisherOA PDFDOI

• Use of organizational change strategies and personalized agency feedback improves addressing tobacco in behavioral health outpatient treatment settings

  Frontiers in Health Services · 2025-10-07

  articleOpen access

  Introduction Implementing evidence-based interventions for tobacco use disorder (TUD) in community mental health agencies is critical, given the low adoption rates of these interventions and the high rates of TUD among patients, contributing to the high morbidity and shortened lifespan of this population. Implementation efforts require enhancing organizational preparedness to integrate these evidence-based interventions. Purpose When the Addressing Tobacco Through Organizational Change (ATTOC) model was evaluated in a cluster-randomized trial (with 13 clinics, 610 clients, and 222 staff) and compared with an education-only intervention, ATTOC proved to be better at having more TUD treatment, policies, and staff skills. This paper presents a secondary analysis focusing only on the ATTOC sites, examining whether clinic-level preparedness is associated with increased implementation activities and estimating the combined direct and indirect impact on patient referrals to evidence-based TUD interventions. Methods Seven sites applied the ATTOC model over 9 months, with the ATTOC Environmental Scan (ES) conducted at baseline and 3, 6, and 9 months to assess the following: (1) the environment inside and outside the building, (2) staff training and personal tobacco use, (3) clinical TUD services and documentation, and (4) tobacco policies. Summary statistics are provided, and generalized linear mixed model analyses for repeated measures were used to assess time trends and relationships among composite preparedness, activities, and number of referrals. Results Over the 9-month period, significant improvements were observed in ES composite preparedness ( p &amp;lt; 0.001) and individual ES areas ( p &amp;lt; 0.001 for each). Eight out of 11 ATTOC Dashboard items showed significant changes, including increased number of patients treated ( p = 0.002); tobacco discussions ( p = 0.022); provision of educational brochures ( p = 0.034); referrals to a Nicotine Anonymous group ( p &amp;lt; 0.001), an in-house wellness or tobacco group ( p &amp;lt; 0.001), and state quitline ( p = 0.012); and documentation in treatment plans ( p = 0.008). Both composite preparedness ( p = 0.006) and composite activities ( p &amp;lt; 0.001) were significantly associated with the number of composite referrals. Conclusion Significant TUD intervention uptake was found over time through the ATTOC model organizational change intervention and tracking tools.

  PublisherOA PDFDOI

• Critical Gaps in the Scientific Basis for Electronic Cigarette Regulation

  CHEST Journal · 2025-11-19

  article1st authorCorresponding
  PublisherDOI

• Pilot Trial of a Behavioral Economics-Informed Clinical Decision Support Alert to Improve Inpatient Tobacco Use Treatment Rates

  Nicotine & Tobacco Research · 2025-06-17 · 1 citations

  articleSenior author

  INTRODUCTION: Evidence-based tobacco use treatment (TUT) improves clinical outcomes, yet few clinicians initiate TUT for hospitalized patients who smoke. Clinical decision support (CDS) tools embedded in electronic health records (EHRs) offer opportunities to guide clinicians toward desired behaviors. CDS alerts informed by behavioral economics (BE-CDS) may increase TUT by presenting preselected orders and requiring justification to opt out. We conducted a pilot study to evaluate the impact of a BE-CDS alert on TUT ordering for inpatients who smoke. AIMS AND METHODS: In a two-arm randomized trial at a large US academic health system, 50 clinicians were randomized to receive either a BE-CDS alert or a standard reminder encouraging inpatient pharmacotherapy and outpatient follow-up. Alerts were triggered upon chart entry for eligible patients. The primary outcome was the rate of any TUT-related order (medication, counseling, or referral). Clinician feedback on alert appropriateness and workflow impact was also collected. RESULTS: From June 2022 to December 2023, 635 inpatients met the inclusion criteria. There were no significant differences in rates of any TUT order (25.2% vs. 28.5%, p = .27), inpatient medication (17.2% vs. 18.4%, p = .62), or discharge medication (7.1% vs. 6.6%, p = .90). Referral to outpatient follow-up was higher in the BE-CDS group (8.4% vs. 3.3%; OR = 2.54, p = .01). Number of alerts delivered, and White patient race, were associated with increased TUT rates. Clinicians preferred the BE-CDS format but cited alert workflow placement as more influential than alert design. CONCLUSIONS: BE-CDS improved referral rates but did not significantly impact overall TUT. Further research should explore deeper drivers of inpatient TUT decision-making. TRIAL REGISTRATION: ClinicalTrials.gov. NCT04738643. Registered February 4, 2021. https://clinicaltrials.gov/study/NCT04738643. IMPLICATIONS: Compared to the standard electronic practice reminders, behavioral economics-informed clinical decision support alerts increased referrals to outpatient tobacco use treatment services for inpatients who smoke, but did not increase tobacco treatment intervention rates during the inpatient stay. Several variables appear to influence rates of tobacco use treatment, including the number of alert interactions and patient race. This pilot study suggests that the barriers to inpatient tobacco interventions may be complex and therefore insensitive to simple behavioral economic nudges.

  PublisherDOI

• Differences in Cognition and Smoking Abstinence Rates Among People With and Without HIV

  Drug and Alcohol Dependence · 2025-02-01

  article
  PublisherDOI

• Effects of Inhaled Tobacco and Cannabis Co-Use on Respiratory Health and Tobacco Cessation: An Official American Thoracic Society Research Statement

  American Journal of Respiratory and Critical Care Medicine · 2025-08-22 · 3 citations

  articleOpen access

  Abstract Background Tobacco and cannabis are among the most widely used substances globally, and rates of co-use are on the rise. Understanding the impact of inhaled tobacco-cannabis co-use on health outcomes and tobacco cessation is critical for guiding patients and clinicians. Objectives To summarize the existing evidence, identify knowledge gaps, and prioritize research questions related to effects of inhaled tobacco-cannabis co-use on tobacco cessation and lung health. Methods A multidisciplinary committee was convened to review the evidence, identify knowledge gaps, and develop research questions in four priority research areas: 1) common data elements and terminology, 2) patterns and prevalence of co-use, 3) impact of co-use on tobacco cessation, and 4) effects of co-use on lung health. A modified Delphi process was conducted in three rounds to reach consensus on prioritizing research questions. Results The evidence reviewed by the expert panel in four priority research areas yielded the following gaps in the literature with high priority to address with future research: 1) lack of consensus on terminology and recommended co-use data elements, 2) limited research on co-use and tobacco-related disparities, 3) insufficient evidence on how cannabis use affects tobacco cessation, and 4) alarming yet inconsistent findings on the effects of co-use on lung health. Conclusions This statement outlines and guides a research agenda on the effects of inhaled tobacco-cannabis co-use on tobacco cessation and lung health. Consensus-driven recommendations include adopting harmonized terms and minimum data elements, studying the prevalence of co-use among populations experiencing tobacco-related disparities, evaluating the impact of co-use on tobacco cessation pharmacotherapies, and assessing the effects of co-use on the development and progression of lung diseases.

  PublisherOA PDFDOI

• A formative study to develop nudges informed by behavioral economics to increase engagement with tobacco treatment among people who smoke receiving care for HIV

  Drug and Alcohol Dependence Reports · 2025-06-25 · 1 citations

  articleOpen access

  The rate of tobacco use among people with HIV (PWH) is >2 fold higher vs. the general population and accounts for more life years lost than the virus. Yet, evidence-based tobacco treatments are uncommonly offered by clinicians or used by PWH. Biases informed by behavioral economics concerning tobacco treatments may drive this practice gap. This formative study tested nudges in the form of messages that target four behavioral economic biases – status quo, availability, omission, and focusing effect – to determine which message would be most strongly associated with PWH willingness to use or clinician referral for tobacco treatment; 19 clinicians and 75 PWH assessed pair-wise comparisons of the four messages with instructions to select the message that, if sent via text or a patient portal, or via the electronic medical record (EMR) at a clinic visit, would increase willingness to use or provide a referral for tobacco treatment. There were significant differences in reported preference across the messages among PWH (χ 2 [3]=24.79, p <0.001) and clinicians ( χ 2 [3]=33.85 , p <0.001). The message that addressed focusing effect bias was most preferred for increasing use and referral for tobacco treatment among PWH (29%) and clinicians (38%). A message that addressed focusing effect bias was associated with greater interest in the use of or referral for tobacco treatment within HIV care. These results can help design a clinical trial to test the effectiveness of these messages within the clinical workflow for their effects on actual use of and referral for tobacco treatment for PWH. • Messages targeting focusing effect bias related to tobacco treatment in HIV care. • Behavioral economics can provide a framework for implementing tobacco treatment. • Results can guide subsequent implementation science studies of tobacco treatment.

  PublisherDOI

• University of Pennsylvania Telehealth Research Center of Excellence

  JNCI Monographs · 2024-06-26 · 1 citations

  articleOpen access

  Drawing from insights from communication science and behavioral economics, the University of Pennsylvania Telehealth Research Center of Excellence (Penn TRACE) is designing and testing telehealth strategies with the potential to transform access to care, care quality, outcomes, health equity, and health-care efficiency across the cancer care continuum, with an emphasis on understanding mechanisms of action. Penn TRACE uses lung cancer care as an exemplar model for telehealth across the care continuum, from screening to treatment to survivorship. We bring together a diverse and interdisciplinary team of international experts and incorporate rapid-cycle approaches and mixed methods evaluation in all center projects. Our initiatives include a pragmatic sequential multiple assignment randomized trial to compare the effectiveness of telehealth strategies to increase shared decision-making for lung cancer screening and 2 pilot projects to test the effectiveness of telehealth to improve cancer care, identify multilevel mechanisms of action, and lay the foundation for future pragmatic trials. Penn TRACE aims to produce new fundamental knowledge and advance telehealth science in cancer care at Penn and nationally.

  PublisherOA PDFDOI

• Effect of early medication adherence on behavioral treatment utilization and smoking cessation among individuals with current or past major depressive disorder

  Addictive Behaviors · 2024-01-04 · 1 citations

  articleOpen access
  PublisherOA PDFDOI

Recent grants

• NIH Grant U10HL051810

  NIH · $5.5M · 2004

Frequent coauthors

• Stanley J. Szefler

  Children's Hospital Colorado

  182 shared

• Elliot Israel

  177 shared

• Monica Kraft

  Icahn School of Medicine at Mount Sinai

  176 shared

• Michael E. Wechsler

  National Jewish Health

  176 shared

• Robert F. Lemanske

  University of Wisconsin–Madison

  175 shared

• John V. Fahy

  University of California System

  175 shared

• Stephen P. Peters

  Wake Forest University

  175 shared

• Stephen C. Lazarus

  175 shared