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Targeted tobacco regulatory science: Nicotine dose effects in animal models of smoking initiation in vulnerable adolescent subpopulations

Award Number: R01DA042525
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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PROJECT SUMMARY/ABSTRACT The purpose of this project is to provide scientific data to the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) to support setting nicotine standards for tobacco products to reduce their addictiveness and adverse public health impact. This proposal addresses the specific RFA-OD-15-006 priority area of using animal models to study adolescent nicotine reinforcement and use behaviors, including initiation. In order to achieve the greatest net population impact, “targeted tobacco regulatory science” is needed to take into account the variability in risk of nicotine addiction between vulnerable subpopulations.. Applying nicotine standards to the general population that are based on vulnerable subgroups will achieve the greatest net population reduction in smoking and improvement in public health. The overall aim of this project is to determine whether depression or attention deficit hyperactivity disorder (ADHD) predispose adolescents to nicotine addiction by lowering the nicotine reinforcement threshold. Adolescents with comorbid depression and Attention Deficit Hyperactivity Disorder (ADHD) have a higher incidence of smoking, start smoking at a younger age, exhibit a faster progression to daily smoking and dependence, and are less successful quitting. We hypothesize that the greater vulnerability of these subgroups is due to their greater sensitivity to nicotine reinforcement (i.e. a lower nicotine reinforcement threshold). Experimental analysis of initiation of smoking in adolescents, and control of nicotine or other drug exposure in general, is difficult or impossible to accomplish in human studies, but can be addressed with animal models. Thus, animal research is vital to the FDA CTP to obtain the most comprehensive and accurate scientific information on which to base a ruling for nicotine standards for tobacco products. Given the greater vulnerability to addiction of adolescents with the comorbidities mentioned above, specific aims of this project are to test the general hypothesis that the nicotine reinforcement threshold is lower in adolescent rat models of depression (Flinders Sensitive Line, Aim 1), and ADHD (Spontaneously Hypertensive Rat, Aim 2) compared to control strains. In each model, the threshold reinforcing nicotine dose for acquisition of nicotine self-administration (NSA) will be determined during adolescence. Elasticity of demand for nicotine (i.e. sensitivity to price) will also be conducted to assess persistence of NSA during increases in price of nicotine (i.e., difficulty reducing intake). In addition, the ability of strain and individual differences in nicotine pharmacokinetics and sex differences to modulate or predict these measures of NSA will be assessed. These data will provide insight into the relative risk of nicotine reinforcement in adolescents, and how these are modified by key comorbidities and other individual differences. This type of “targeted tobacco regulatory science” is vital to the efforts of the FDA CTP to establish nicotine standards sufficient to prevent smoking initiation in both the general population and vulnerable subpopulations of adolescents, and thereby maximize the net population impact of a nicotine reduction policy on public health.


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: 2022 ( Subtotal = -$1,980 )
2022	2018	HENNEPIN HEALTHCARE RESEARCH INSTITUTE	701 PARK AVE	MINNEAPOLIS	MN	55415	HENNEPIN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	3	12/6/2021	SUPPLEMENT FOR EXPANSION	-$1,980
														Subtotal = -$1,980

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2018	HENNEPIN HEALTHCARE RESEARCH INSTITUTE	701 PARK AVE	MINNEAPOLIS	MN	55415	HENNEPIN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	3	6/24/2021	SUPPLEMENT FOR EXPANSION	$0
2021	2018	HENNEPIN HEALTHCARE RESEARCH INSTITUTE	701 PARK AVE	MINNEAPOLIS	MN	55415	HENNEPIN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	3	6/22/2021	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = -$1,922 )
2020	2018	HENNEPIN HEALTHCARE RESEARCH INSTITUTE	701 PARK AVE	MINNEAPOLIS	MN	55415	HENNEPIN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	3	9/8/2020	SUPPLEMENT FOR EXPANSION	-$1,922
														Subtotal = -$1,922

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2018	HENNEPIN HEALTHCARE RESEARCH INSTITUTE	701 PARK AVE	MINNEAPOLIS	MN	55415	HENNEPIN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	3	2/21/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $487,819 )
2018	2018	MINNEAPOLIS MEDICAL RESEARCH FOUNDATION	701 PARK AVE	MINNEAPOLIS	MN	55415	HENNEPIN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	3	5/24/2018	NON-COMPETING CONTINUATION	$423,477
2018	2018	MINNEAPOLIS MEDICAL RESEARCH FOUNDATION	701 PARK AVE	MINNEAPOLIS	MN	55415	HENNEPIN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	3	8/7/2018	SUPPLEMENT FOR EXPANSION	$64,342
														Subtotal = $487,819

Issue Date FY: 2017 ( Subtotal = $460,351 )
2017	2017	MINNEAPOLIS MEDICAL RESEARCH FOUNDATION	701 PARK AVE	MINNEAPOLIS	MN	55415	HENNEPIN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	002	2	6/29/2017	NON-COMPETING CONTINUATION	$460,351
2017	2017	MINNEAPOLIS MEDICAL RESEARCH FOUNDATION	701 PARK AVE	MINNEAPOLIS	MN	55415	HENNEPIN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	2	5/25/2017	NON-COMPETING CONTINUATION	$460,351
2017	2017	MINNEAPOLIS MEDICAL RESEARCH FOUNDATION	701 PARK AVE	MINNEAPOLIS	MN	55415	HENNEPIN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	2	6/15/2017	NON-COMPETING CONTINUATION	-$460,351
														Subtotal = $460,351

Issue Date FY: 2016 ( Subtotal = $514,144 )
2016	2016	MINNEAPOLIS MEDICAL RESEARCH FOUNDATION	825 SOUTH 8TH STREET, STE M-50	MINNEAPOLIS	MN	55404	HENNEPIN	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	1	8/15/2016	NEW	$514,144
														Subtotal = $514,144

Grand Total All Awards = $1,458,412

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Targeted tobacco regulatory science: Nicotine dose effects in animal models of smoking initiation in vulnerable adolescent subpopulations

Award Number: R01DA042525

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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