Notice of Special Interest (NOSI): Electronic Nicotine Delivery Systems (ENDS) and Alternative Nicotine and Tobacco Delivery Systems: Basic Mechanisms of Health Effects

Organization
NIH
Type
NIH
Application Due Date
05-08-2023
Number
NOT-OD-21-127
Comments
First Available Due Date: 10/5/21. Expiration Date: 5/8/23.
Brief Description

The Office of Disease Prevention and participating ICOs are issuing this Notice to communicate our interest in research examining how electronic nicotine delivery systems (ENDS) affect normal and disease states relevant to human cells, tissues, organs, and behaviors. Research on alternative nicotine and tobacco delivery systems [e.g., heated tobacco products (also called heat-not-burn)] will also be considered. Studies exclusively examining smokeless tobacco or combustible tobacco products (e.g., cigarettes, cigars) will be considered non-responsive.

Background:

Electronic Nicotine Delivery Systems (ENDS) are designed to heat a liquid solution, typically containing nicotine, into an aerosol to be inhaled by a user. ENDS represent a diverse class of products that include e-cigarettes, vapes, vaporizers, vape pens, hookah pens, and pods. In recent years, heated tobacco products, which do not involve combustion and are sometimes called “heat-not-burn", have become available in the United States. For the purposes of this Notice, research examining products within the entire class of ENDS and heated tobacco products is sought. Other emerging non-combustible products will be considered on a case-by-case basis.

Adult prevalence of ENDS in 2019 was 4.5%, with young adults having the highest prevalence among all age groups (2020 Morbidity and Mortality Weekly Report). Current electronic cigarette use among young adults aged 18-24 increased from 7.6% in 2018 to 9.3% in 2019 (2019 Morbidity and Mortality Weekly Report)Youth ENDS use is also a significant concern. According to the 2020 National Youth Tobacco Survey, 20% (3 million) of high school students and 4.7% (550,000) of middle school students reported current e-cigarette use.

The tobacco product landscape is continuously changing. Despite rapidly accumulating research, significant gaps remain in our understanding of the public health effects posed by ENDS and heated tobacco products. More information is needed to understand the risk profile of the various devices or products and the aerosols they generate. The constantly changing landscape presents additional challenges for understanding how variable patterns of use and exposure to ENDS aerosol affect biological, physiological, and behavioral health outcomes.

Research is needed to understand how ENDS product characteristics, product user characteristics, as well as the communication and policy environment interact to affect ENDS use patterns (e.g., exclusive use vs. dual use with combustible cigarettes). For example, although many adult smokers report using ENDS to help them quit smoking or to reduce their cigarette consumption, as noted in the 2020 Surgeon General’s Report on Smoking Cessation, there is presently inadequate evidence to conclude that e-cigarettes, in general, increase smoking cessation.

The degree to which changes in the devices, products, or aerosols affect nicotine delivery is unknown. Furthermore, questions about their effect on human physiology and behavior still exist. For example, while many of the flavoring chemicals used in the liquids are approved for use in foods, there is incomplete information on their effects when inhaled. Such gaps in our understanding around ENDS and heated tobacco products indicate the need for further investigation at the molecular, cellular, physiological, and behavioral levels to increase our understanding of the risks and potential benefits. These and other research gaps introduce challenges for accurate and meaningful communication about ENDS and heated tobacco products’ impact on an individual’s health.

Research Objectives:

This NOSI encourages research on ENDS and heated tobacco products related to:

  • evaluating the biological mechanisms whereby aerosols affect the normal and disease states relevant to human cells, tissues, or organs
  • understanding the generation and characteristics of aerosols
  • understanding how constituents alter molecular, cellular, and physiological pathways important in maintaining homeostatic functions or progression to disease states
  • developing specific biomarkers that reflect short- and long-term exposure to aerosols and could provide information on the risks or benefits of exposure
  • understanding the short- and long-term health effects across subject populations
  • understanding the neurobiological and behavioral mechanisms associated with exposure to aerosols, and their long-term consequences
  • determining whether and how exposure to aerosols specifically affects development during adolescence, given that this is a window of neural plasticity and dynamic hormonal changes; and
  • Identifying potential sex differences in the effects of aerosol exposure

This NOSI encourages feasibility and pilot research, as well as efficacy and effectiveness research on new or adapted interventions. Investigators must carefully review the specific research interests of NIH Institutes, Centers, and Offices that are participating in this NOSI. Responsive studies should make use of human cells or specimens, and where appropriate, may utilize cell or animal models that are relevant to humans and well justified. Research with a focus on other non-combustible nicotine and tobacco products will be considered on a case-by-case basis. Specific Research areas of interest for participating NIH institutes are listed below.

Where appropriate, the standardized research e-cigarette (https://www.drugabuse.gov/funding/supplemental-information-nida-e-cig) should be considered for use in addressing specific research questions, or as a comparator for commercially available ENDS.

Investigators who conduct original and innovative basic biomedical, social, behavioral, clinical, or population-based research directed toward eliminating health disparities are invited to apply to this NOSI. Research shows that diverse teams working together outperform homogenous teams. Scientists and trainees from diverse backgrounds and with different life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. Diverse teams of scientists will lead the way to develop more innovative inclusive research that will more broadly enhance public health. Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support, and maintain the quality of our scientific workforce. It is expected that research programs will include a diverse group of scientists, including individuals from underrepresented backgrounds as per NOT OD 20-031 (Notice of NIH's Interest in Diversity).