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An evaluation of Beta-nicotyrine as a potential contributor to the abuse liability of e-cigarettes

Award Number: R01DA053608
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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An evaluation of Beta-nicotyrine as a potential contributor to the abuse liability of e-cigarettes - Project Summary/Abstract Addiction to ENDS products is a newly emerging form of nicotine addiction. Understanding the product characteristics and the harmful and potentially harmful constituents (HPHCs) that contribute to ENDS addiction is vital for effective FDA CTP regulation. This HPHC list, however, was last updated in 2012, just prior to the rise in ENDS popularity. Since two of the five addiction-related HPHCs are tobacco-related minor alkaloids (e.g., nornicotine), then it suggests research on ENDS-specific minor alkaloids is warranted. One uniquely prevalent minor alkaloid in ENDS is β-nicotyrine, which is formed by aging and/or aerosolizing e-liquids and can reach 25% of nicotine levels when vaped. Our pilot work found that β-nicotyrine approximately doubles the half-life of nicotine and that it functions as a nicotinic acetylcholine receptor (nAChR) agonist with functional efficacy at α4β2 nicotinic-AChRs similar to nornicotine. Given its a) abundance in ENDS aerosols, b) similarities to nornicotine, and c) ability to inhibit nicotine metabolism, β-nicotyrine may contribute to the addiction-relevant effects of ENDS and represent a novel HPHC. If we find β-nicotyrine has abuse liability or increases the abuse liability of nicotine, it suggests the CTP should consider it a HPHC given that the FDA considers other less prevalent minor alkaloids as HPHCs. The present project will initially characterize the pharmacokinetics of β- nicotyrine and its interaction with nicotine metabolism, and then subsequently determine its effects in FDA- recommended animal models of abuse liability, including drug discrimination, intracranial self-stimulation (ICSS) and drug self-administration. This project is innovative because: 1) it extends research on minor alkaloids, a class of constituents that includes HPHCs with established abuse liability, 2) it will be the first to examine the abuse liability of β-nicotyrine and its ability to alter the abuse liability of nicotine, including at vaping relevant concentrations, and 3) it will be the first to characterize the PK of β-nicotyrine and how it alters nicotine PK. In so doing, this project could elucidate novel mechanisms mediating ENDS addiction and test the proposed β- nicotyrine hypothesis.


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 = -$21,030 )
2026	2023	HENNEPIN HEALTHCARE RESEARCH INSTITUTE	701 PARK AVE	MINNEAPOLIS	MN	55415	HENNEPIN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	3	2/23/2026	NON-COMPETING CONTINUATION	-$21,030
														Subtotal = -$21,030

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2023	HENNEPIN HEALTHCARE RESEARCH INSTITUTE	701 PARK AVE	MINNEAPOLIS	MN	55415	HENNEPIN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	3	12/9/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	HENNEPIN HEALTHCARE RESEARCH INSTITUTE	701 PARK AVE	MINNEAPOLIS	MN	55415	HENNEPIN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	3	8/29/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $330,726 )
2023	2023	HENNEPIN HEALTHCARE RESEARCH INSTITUTE	701 PARK AVE	MINNEAPOLIS	MN	55415	HENNEPIN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	3	8/21/2023	NON-COMPETING CONTINUATION	$330,726
														Subtotal = $330,726

Issue Date FY: 2022 ( Subtotal = $328,441 )
2022	2022	HENNEPIN HEALTHCARE RESEARCH INSTITUTE	701 PARK AVE	MINNEAPOLIS	MN	55415	HENNEPIN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	2	8/23/2022	NON-COMPETING CONTINUATION	$328,441
2022	2021	HENNEPIN HEALTHCARE RESEARCH INSTITUTE	701 PARK AVE	MINNEAPOLIS	MN	55415	HENNEPIN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	1	10/27/2021	NEW	$0
														Subtotal = $328,441

Issue Date FY: 2021 ( Subtotal = $329,488 )
2021	2021	HENNEPIN HEALTHCARE RESEARCH INSTITUTE	701 PARK AVE	MINNEAPOLIS	MN	55415	HENNEPIN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	1	9/8/2021	NEW	$329,488
														Subtotal = $329,488

Grand Total All Awards = $967,625

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An evaluation of Beta-nicotyrine as a potential contributor to the abuse liability of e-cigarettes

Award Number: R01DA053608

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/15/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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