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4th Generation e-cigarettes in African American Smokers: Reducing Harm and Quitting Combustible Cigarettes in Dual Users

Award Number: R01MD018123
ORGANIZATION: NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/14/2022
PERIOD OF PERFORMANCE END DATE: 02/28/2027

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4th Generation e-cigarettes in African American Smokers: Reducing Harm and Quitting Combustible Cigarettes in Dual Users - PROJECT SUMMARY E-cigarettes (EC) are an effective harm reduction strategy in adult combustible cigarette smokers who exclusively switch to EC, yet African American (AA) have been slower to adopt EC and are underrepresented in EC research, contributing to an almost complete lack of knowledge about EC as a harm reduction strategy for a group experiencing the highest risk of tobacco-related morbidity and mortality. Relatively little is known about 4th generation nicotine salt-based pod systems (NSPS), which are the leading class of EC. NSPS EC contain high nicotine concentrations with rapid nicotine delivery that facilitates exclusive switching. Our pilot data provide strong preliminary evidence of EC as a harm reduction strategy for AA smokers but there is an urgent need to conduct a fully powered trial with longer follow-up. Moreover, to enhance EC as a harm reduction strategy, there is a critical need for interventions to support exclusive switching in dual cig-EC users who try but initially fail. No such interventions exist. A recent open label study found that varenicline (VAR) helped dual users eliminate cigarette use but this has strategy not been tested in an RCT. Failure to intervene with dual users is a missed opportunity among a group who comprises the largest proportion of EC users (> 50%) and is already motivated to reduce their harm from smoking. The objectives of this application are to 1) compare short- and long-term harm reduction and abuse liability potential (i.e., withdrawal, craving, dependence) of a NSPS EC in AA exclusive EC, dual cig-EC, and exclusive cig users, 2) characterize factors that predict who switches fully, partially, or not at all, and 3) examine if harm reduction can be further enhanced by treating dual users with VAR to eliminate cigarette smoking. Objectives will be accomplished by conducting a 6-week open- label trial of a NSPS EC and counseling to facilitate a complete switch to EC in AA cigarette smokers (n=500) who are not interested in quitting all nicotine products but are interested in switching to EC. We enhance harm reduction potential and capitalize on a missed opportunity by offering dual users additional support to make a complete switch. At six weeks, those who are dual users (n= ~221) will receive an additional 12 weeks of the NSPS EC, ongoing counseling to make a complete switch, and be randomized to receive 12 weeks of VAR or placebo (PBO) to support quitting combustible cigarettes. Follow-up will continue for one-year, providing, to our knowledge, the first evidence on the long-term harm reduction potential of NSPC EC. The current study is the first to examine the short- and long-term harm reduction potential of NSPS EC in a priority population and the first to examine pharmacological support for dual cig-EC users in making a complete switch to EC. Findings have the potential to support EC as a harm reduction strategy among a disparate group that arguably stands to benefit from it the most, contribute to the overall goal of reducing tobacco-related morbidity and mortality, and narrow the health disparity gap for AA 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: 2025 ( Subtotal = $624,808 )
2025	2025	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	3901 RAINBOW BLVD	KANSAS CITY	KS	66160	WYANDOTTE	USA	Minority Health and Health Disparities Research	002	4	4/18/2025	NON-COMPETING CONTINUATION	$624,808
2025	2024	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	3901 RAINBOW BLVD	KANSAS CITY	KS	66160	WYANDOTTE	USA	Minority Health and Health Disparities Research	001	3	4/18/2025	NON-COMPETING CONTINUATION	$0
2025	2024	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	3901 RAINBOW BLVD	KANSAS CITY	KS	66160	WYANDOTTE	USA	Minority Health and Health Disparities Research	000	3	3/7/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $624,808

Issue Date FY: 2024 ( Subtotal = $614,275 )
2024	2024	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	3901 RAINBOW BLVD	KANSAS CITY	KS	66160	WYANDOTTE	USA	Minority Health and Health Disparities Research	001	3	6/17/2024	NON-COMPETING CONTINUATION	$44,329
2024	2024	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	3901 RAINBOW BLVD	KANSAS CITY	KS	66160	WYANDOTTE	USA	Minority Health and Health Disparities Research	000	3	2/9/2024	NON-COMPETING CONTINUATION	$569,946
														Subtotal = $614,275

Issue Date FY: 2023 ( Subtotal = $642,979 )
2023	2023	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	3901 RAINBOW BLVD	KANSAS CITY	KS	66160	WYANDOTTE	USA	Minority Health and Health Disparities Research	000	2	2/21/2023	NON-COMPETING CONTINUATION	$642,979
2023	2022	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	3901 RAINBOW BLVD	KANSAS CITY	KS	66160	WYANDOTTE	USA	Minority Health and Health Disparities Research	001	1	2/22/2023	NEW	$0
														Subtotal = $642,979

Issue Date FY: 2022 ( Subtotal = $642,875 )
2022	2022	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Minority Health and Health Disparities Research	000	1	5/14/2022	NEW	$642,875
														Subtotal = $642,875

Grand Total All Awards = $2,524,937

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4th Generation e-cigarettes in African American Smokers: Reducing Harm and Quitting Combustible Cigarettes in Dual Users

Award Number: R01MD018123

ORGANIZATION: NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/14/2022

PERIOD OF PERFORMANCE END DATE: 02/28/2027

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