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Predicting Effects of ENDS Flavor Regulations on Tobacco Behavior, Toxicity, and Abuse Liability among African American Menthol Smokers

Award Number: R01DA050996
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. Black/African Americans (AA) have the highest tobacco-related cancer incidence and mortality rates of any racial/ethnic group. Over 70% of AA smokers smoke menthol as their usual brand, compared to 20% for White smokers. Menthol is the only characterizing flavor allowed in cigarettes under current federal regulations, and menthol use is associated with progression to established cigarette smoking as well as more difficulty quitting. Evidence regarding the effects of electronic nicotine delivery systems (ENDS, i.e., e-cigarettes) suggests these products may be a less harmful alternative to cigarettes. Little work has examined how ENDS uptake affects tobacco use and associated toxicity among AA smokers, particularly those who smoke menthol. Recently, FDA began regulating closed-system devices like JUUL, which have captured over 70% of the ENDS market and contributed to dramatic increases in youth ENDS use. As of early 2020, flavored ENDS cartridges (small, enclosed unit used as part of an ENDS) other than menthol/tobacco are banned in the US. However, to achieve its public health mission, the FDA must balance restricting access to ENDS flavors that appeal to youth with the need for evidence on “whether and how certain flavors may help adult cigarette smokers reduce cigarette use and switch to potentially less harmful products” (FDA, 2018). Understanding the potential of ENDS to reduce the public health burden of combusted tobacco use equitably requires a targeted study to predict how future ENDS flavor regulations will impact AA menthol smokers. The current study will evaluate whether ENDS menthol flavor availability affects measures of tobacco use, biomarkers of cigarette/ENDS exposure, and addiction among AA menthol smokers (N=210) by performing a 3-arm, parallel-group, 6-week clinical trial of ENDS provision with follow-up to 30 days. JUUL devices with compatible cartridges at 5% nicotine, which our team has extensively evaluated, will be provided. Study arms will differ by potential FDA regulations on ENDS flavor availability: 1) the current market where only menthol and tobacco flavored ENDS cartridges are available; 2) a market where only tobacco flavor is available, and 3) a market with only unflavored cartridges. Study visits will occur weekly beginning 1 week prior to randomization with daily tobacco use monitoring throughout and biomarker/self-report data collection at each weekly visit. AA menthol smokers are disproportionately harmed by tobacco products and could experience significant health benefits from increased availability of well-regulated ENDS. Results of this work will help FDA make predictions about the impact on AA menthol smokers of moving from the current regulatory market for cartridge-based ENDS where menthol and tobacco are available, to one where only tobacco or no flavors are available. Answers to these questions will address FDA's priorities in behavior, toxicity, and addiction, and will provide new data regarding the consequences of potential FDA regulatory actions on menthol flavor ENDS to help maximize health-promoting effects and minimize unintended consequences among AA menthol smokers.


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: 2024 ( Subtotal = $0 )
2024	2023	VIRGINIA COMMONWEALTH UNIVERSITY	910 WEST FRANKLIN ST	RICHMOND	VA	23284	RICHMOND CITY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	3	7/12/2024	NON-COMPETING CONTINUATION	$0
2024	2023	VIRGINIA COMMONWEALTH UNIVERSITY	910 WEST FRANKLIN ST	RICHMOND	VA	23284	RICHMOND CITY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	3	11/3/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $517,331 )
2023	2023	VIRGINIA COMMONWEALTH UNIVERSITY	910 WEST FRANKLIN ST	RICHMOND	VA	23284	RICHMOND CITY	USA	Drug Abuse and Addiction Research Programs	004	3	6/27/2023	SUPPLEMENT FOR EXPANSION	$23,561
2023	2023	VIRGINIA COMMONWEALTH UNIVERSITY	910 WEST FRANKLIN ST	RICHMOND	VA	23284	RICHMOND CITY	USA	Drug Abuse and Addiction Research Programs	001	2	1/23/2023	SUPPLEMENT FOR EXPANSION	$47,121
2023	2023	VIRGINIA COMMONWEALTH UNIVERSITY	910 WEST FRANKLIN ST	RICHMOND	VA	23284	RICHMOND CITY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	003	3	6/26/2023	NON-COMPETING CONTINUATION	$446,649
2023	2022	VIRGINIA COMMONWEALTH UNIVERSITY	910 WEST FRANKLIN ST	RICHMOND	VA	23284	RICHMOND CITY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	002	2	2/17/2023	NON-COMPETING CONTINUATION	$0
2023	2022	VIRGINIA COMMONWEALTH UNIVERSITY	912 W FRANKLIN ST	RICHMOND	VA	23284	RICHMOND CITY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	2	11/2/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $517,331

Issue Date FY: 2022 ( Subtotal = $454,834 )
2022	2022	VIRGINIA COMMONWEALTH UNIVERSITY	912 W FRANKLIN ST	RICHMOND	VA	23284	RICHMOND CITY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	2	6/23/2022	NON-COMPETING CONTINUATION	$454,834
														Subtotal = $454,834

Issue Date FY: 2021 ( Subtotal = $465,589 )
2021	2021	VIRGINIA COMMONWEALTH UNIVERSITY	912 W FRANKLIN ST	RICHMOND	VA	23284	RICHMOND CITY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	1	6/11/2021	NEW	$465,589
2021	2021	VIRGINIA COMMONWEALTH UNIVERSITY	912 W FRANKLIN ST	RICHMOND	VA	23284	RICHMOND CITY	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	1	6/15/2021	NEW	$0
														Subtotal = $465,589

Grand Total All Awards = $1,437,754

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Predicting Effects of ENDS Flavor Regulations on Tobacco Behavior, Toxicity, and Abuse Liability among African American Menthol Smokers

Award Number: R01DA050996

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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