학술논문
Nicotine flux as a powerful tool for regulating nicotine delivery from e-cigarettes: Protocol of two complimentary randomized crossover clinical trials.
Document Type
Academic Journal
Author
El-Hellani A; Division of Environmental Health Sciences, College of Public Health, The Ohio State University, Columbus, Ohio, United States of America.; Center for Tobacco Research, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States of America.; Hanna E; Department of Mechanical Engineering, Maroun Semaan Faculty of Engineering and Architecture, American University of Beirut, Beirut, Lebanon.; Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, Virginia, United States of America.; Sharma M; Section of Pulmonary, Critical Care, and Sleep Medicine, Yale School of Medicine, New Haven, Connecticut, United States of America.; Blohowiak R; Section of Pulmonary, Critical Care, and Sleep Medicine, Yale School of Medicine, New Haven, Connecticut, United States of America.; Joseph P; Section of Pulmonary, Critical Care, and Sleep Medicine, Yale School of Medicine, New Haven, Connecticut, United States of America.; Eid T; Department of Laboratory Medicine, Yale School of Medicine, Washington, DC, United States of America.; Nadim H; Department of Laboratory Medicine, Yale School of Medicine, Washington, DC, United States of America.; El-Hage R; Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, Virginia, United States of America.; Department of Chemistry, Faculty of Arts and Sciences, American University of Beirut, Beirut, Lebanon.; Salman R; Department of Mechanical Engineering, Maroun Semaan Faculty of Engineering and Architecture, American University of Beirut, Beirut, Lebanon.; Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, Virginia, United States of America.; Karaoghlanian N; Department of Mechanical Engineering, Maroun Semaan Faculty of Engineering and Architecture, American University of Beirut, Beirut, Lebanon.; Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, Virginia, United States of America.; Adeniji A; Division of Environmental Health Sciences, College of Public Health, The Ohio State University, Columbus, Ohio, United States of America.; Center for Tobacco Research, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States of America.; Salam S; Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, Virginia, United States of America.; Department of Chemistry, Faculty of Arts and Sciences, American University of Beirut, Beirut, Lebanon.; Talih F; Clinical Psychiatry, Faculty of Medicine, American University of Beirut, Beirut, Lebanon.; Elbejjani M; Clinical Research Institute & Department of Internal Medicine, Faculty of Medicine, American University of Beirut, Beirut, Lebanon.; Breland A; Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, Virginia, United States of America.; Department of Psychology, Virginia Commonwealth University, Richmond, Virginia, United States of America.; Eissenberg T; Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, Virginia, United States of America.; Department of Psychology, Virginia Commonwealth University, Richmond, Virginia, United States of America.; Shihadeh A; Department of Mechanical Engineering, Maroun Semaan Faculty of Engineering and Architecture, American University of Beirut, Beirut, Lebanon.; Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, Virginia, United States of America.; Baldassarri SR; Section of Pulmonary, Critical Care, and Sleep Medicine, Yale School of Medicine, New Haven, Connecticut, United States of America.; Yale Center for the Study of Tobacco Product Use and Addiction, Yale University, New Haven, Connecticut, United States of America.; Program in Addiction Medicine, Yale School of Medicine, Washington, DC, United States of America.; Talih S; Department of Mechanical Engineering, Maroun Semaan Faculty of Engineering and Architecture, American University of Beirut, Beirut, Lebanon.; Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, Virginia, United States of America.
Source
Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE
Subject
Language
English
Abstract
Introduction: Electronic cigarette (EC) use has increased rapidly in the last decade, especially among youth. Regulating nicotine delivery from ECs could help curb youth uptake and leverage EC use in harm reduction yet is complicated by varying device and liquid variables that affect nicotine delivery. Nicotine flux, the nicotine emission rate, is a parameter that incorporates these variables and focuses on the performance rather than the design of an EC. Nicotine flux therefore could be a powerful regulatory tool if it is shown empirically to predict nicotine delivery and subjective effects related to dependence.
Methods and Analysis: This project consists of two complementary clinical trials. In Trial I, we will examine the relationship between nicotine flux and the rate and dose of nicotine delivery from ECs, hence, impacting abuse liability. It will also examine the extent to which this relationship is mediated by nicotine form (i.e., freebase versus protonated). At Yale School of Medicine (YSM), study participants will puff EC devices under conditions that differ by flux and form, while arterial blood is sampled in high time resolution. In Trial II, we will assess the relationship between nicotine flux, form, and subjective effects. At the American University of Beirut (AUB), participants will use EC devices with varying nicotine fluxes and forms, while dependency measures, such as the urge to use ECs, nicotine craving, and withdrawal symptoms, will be assessed. We will also monitor puffing intensity and real-time exposure to toxicants.
Ethics and Dissemination: The protocol of Trial I and Trial II was approved by YSM and AUB IRBs, respectively. We will disseminate study results through peer-reviewed publications and conference presentations.
Trial Registration: NCT05706701 for Trial I and NCT05430334 for Trial II.
Competing Interests: AS and TEissenberg are paid consultants in litigation against the tobacco and EC industry and are named on a patent for a device that measures the puffing behavior of EC users and another patent application for a smoking cessation intervention. TEissenberg is also named on a patent application for a smartphone app that determines EC device and liquid characteristics. All other authors declare no conflict of interest. This does not alter our adherence to PLOS ONE policies on sharing data and materials.
(Copyright: © 2023 El-Hellani et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
Methods and Analysis: This project consists of two complementary clinical trials. In Trial I, we will examine the relationship between nicotine flux and the rate and dose of nicotine delivery from ECs, hence, impacting abuse liability. It will also examine the extent to which this relationship is mediated by nicotine form (i.e., freebase versus protonated). At Yale School of Medicine (YSM), study participants will puff EC devices under conditions that differ by flux and form, while arterial blood is sampled in high time resolution. In Trial II, we will assess the relationship between nicotine flux, form, and subjective effects. At the American University of Beirut (AUB), participants will use EC devices with varying nicotine fluxes and forms, while dependency measures, such as the urge to use ECs, nicotine craving, and withdrawal symptoms, will be assessed. We will also monitor puffing intensity and real-time exposure to toxicants.
Ethics and Dissemination: The protocol of Trial I and Trial II was approved by YSM and AUB IRBs, respectively. We will disseminate study results through peer-reviewed publications and conference presentations.
Trial Registration: NCT05706701 for Trial I and NCT05430334 for Trial II.
Competing Interests: AS and TEissenberg are paid consultants in litigation against the tobacco and EC industry and are named on a patent for a device that measures the puffing behavior of EC users and another patent application for a smoking cessation intervention. TEissenberg is also named on a patent application for a smartphone app that determines EC device and liquid characteristics. All other authors declare no conflict of interest. This does not alter our adherence to PLOS ONE policies on sharing data and materials.
(Copyright: © 2023 El-Hellani et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)