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Nicotine flux, a potentially powerful tool for regulating nicotine delivery from electronic cigarettes: significance of nicotine flux to the rate of nicotine delivery and subjective effects

Award Number: R01DA052565
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2022
PERIOD OF PERFORMANCE END DATE: 01/31/2026

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Nicotine flux, a potentially powerful tool for regulating nicotine delivery from electronic cigarettes: significance of nicotine flux to the rate of nicotine delivery and subjective effects - Project summary. Electronic nicotine delivery systems (ENDS) heat and vaporize a nicotine-containing liquid to produce an aerosol that can deliver nicotine to the blood and the brain. ENDS are considered tobacco products in the US and are under the regulatory authority of the Food and Drug Administration. ENDS use has increased rapidly in the last decade, especially among youth: over 20% of US high school students are current ENDS users, and there is evidence of nicotine dependence in this population. Federal legislation has been proposed that would restrict ENDS liquid nicotine concentration to make ENDS “significantly less addictive and appealing to youth.” However, these and other efforts to curb addiction by limiting nicotine liquid concentration are unlikely to succeed because nicotine emissions from ENDS depend on multiple variables. For example, where nicotine concentration is limited, users can turn to a higher power ENDS device to attain more nicotine. To achieve the intended public health aims, regulations targeting addiction must focus on nicotine delivery, not nicotine concentration. While nicotine delivery cannot be regulated directly, the rate at which an ENDS emits nicotine, the “nicotine flux” can be regulated and, importantly, predicted from first-principles based on knowledge of a few device design and operating variables. However, to date there is no empirical evidence demonstrating the relationship between flux and delivery, nor between flux and the physiological and subjective effects that support nicotine dependence. Closing this gap is essential for providing an effective, first-principles framework for regulating ENDS. In Aim1, we will examine the relationship between nicotine flux, nicotine form, and the rate and dose of nicotine delivery. In the clinical lab at Yale University, participants will puff on ENDS devices under conditions that differ by flux and form, while arterial blood is sampled in high time resolution. The outcome will indicate the degree to which nicotine flux and form determine the speed and dose of ENDS nicotine delivery, and thus, abuse liability. In Aim2, we will assess the relationship between nicotine flux, form, and subjective effects. At the American University of Beirut, participants will use ENDS devices with varying nicotine fluxes and forms. Dependency measures, such as urge to smoke, craving, and abstinence, will be assessed. The outcome will indicate the degree to which nicotine flux/form influence subjective effects related to dependency, puffing intensity, and exposure to toxicants. In summary, this project will provide the empirical evidence needed for public health agencies to use nicotine flux as an encompassing and convenient construct to regulate nicotine delivery from ENDS.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = -$12,418 )
2026	2024	AMERICAN UNIVERSITY OF BEIRUT	3 DAG HAMMARSKJOLD PLZ	NEW YORK	NY	10017	NEW YORK	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	3	5/27/2026	NON-COMPETING CONTINUATION	-$12,418
														Subtotal = -$12,418

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	AMERICAN UNIVERSITY OF BEIRUT	3 DAG HAMMARSKJOLD PLZ	NEW YORK	NY	10017	NEW YORK	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	3	12/6/2024	NON-COMPETING CONTINUATION	$0
2025	2024	AMERICAN UNIVERSITY OF BEIRUT	3 DAG HAMMARSKJOLD PLZ	NEW YORK	NY	10017	NEW YORK	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	3	11/18/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $439,476 )
2024	2024	AMERICAN UNIVERSITY OF BEIRUT	3 DAG HAMMARSKJOLD PLZ	NEW YORK	NY	10017	NEW YORK	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	3	1/5/2024	NON-COMPETING CONTINUATION	$439,476
2024	2023	AMERICAN UNIVERSITY OF BEIRUT	3 DAG HAMMARSKJOLD PLZ	NEW YORK	NY	10017	NEW YORK	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	2	11/10/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $439,476

Issue Date FY: 2023 ( Subtotal = $443,108 )
2023	2023	AMERICAN UNIVERSITY OF BEIRUT	3 DAG HAMMARSKJOLD PLZ	NEW YORK	NY	10017	NEW YORK	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	003	2	6/23/2023	NON-COMPETING CONTINUATION	$0
2023	2023	AMERICAN UNIVERSITY OF BEIRUT	3 DAG HAMMARSKJOLD PLZ	NEW YORK	NY	10017	NEW YORK	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	2	5/24/2023	NON-COMPETING CONTINUATION	$0
2023	2023	AMERICAN UNIVERSITY OF BEIRUT	3 DAG HAMMARSKJOLD PLZ	NEW YORK	NY	10017	NEW YORK	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	2	1/18/2023	NON-COMPETING CONTINUATION	$443,108
2023	2022	AMERICAN UNIVERSITY OF BEIRUT	3 DAG HAMMARSKJOLD PLZ	NEW YORK	NY	10017	NEW YORK	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	002	1	6/5/2023	NEW	$0
														Subtotal = $443,108

Issue Date FY: 2022 ( Subtotal = $444,512 )
2022	2022	AMERICAN UNIVERSITY OF BEIRUT	3 DAG HAMMARSKJOLD PLAZA 8TH FL	NEW YORK	NY	10017	NEW YORK	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	005	1	4/8/2022	NEW	$0
2022	2022	AMERICAN UNIVERSITY OF BEIRUT	3 DAG HAMMARSKJOLD PLAZA 8TH FL	NEW YORK	NY	10017	NEW YORK	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	1	1/24/2022	NEW	$398,242
2022	2022	AMERICAN UNIVERSITY OF BEIRUT	3 DAG HAMMARSKJOLD PLAZA 8TH FL	NEW YORK	NY	10017	NEW YORK	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	003	1	2/4/2022	NEW	-$15,388
2022	2022	AMERICAN UNIVERSITY OF BEIRUT	3 DAG HAMMARSKJOLD PLAZA 8TH FL	NEW YORK	NY	10017	NEW YORK	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	002	1	2/2/2022	NEW	$0
2022	2022	AMERICAN UNIVERSITY OF BEIRUT	3 DAG HAMMARSKJOLD PLAZA 8TH FL	NEW YORK	NY	10017	NEW YORK	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	1	1/27/2022	NEW	$61,658
2022	2022	AMERICAN UNIVERSITY OF BEIRUT	3 DAG HAMMARSKJOLD PLAZA 8TH FL	NEW YORK	NY	10017	NEW YORK	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	004	1	2/21/2022	NEW	$0
														Subtotal = $444,512

Grand Total All Awards = $1,314,678

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Nicotine flux, a potentially powerful tool for regulating nicotine delivery from electronic cigarettes: significance of nicotine flux to the rate of nicotine delivery and subjective effects

Award Number: R01DA052565

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/01/2022

PERIOD OF PERFORMANCE END DATE: 01/31/2026

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