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An Addictions Neuroclinical Assessment Based Treatment for Smokers with an Alcohol Use Disorder

Award Number: R01CA252185
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/01/2021
PERIOD OF PERFORMANCE END DATE: 04/30/2026

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An Addictions Neuroclinical Assessment Based Treatment for Smokers with an Alcohol Use Disorder - PROJECT SUMMARY/ABSTRACT Together, tobacco and alcohol kill more than half a million people in the United States every year, making co- addiction to these substances the leading cause of preventable death. We propose a contingency management (CM) paradigm based on point-of-care urine tests that measure ethyl glucuronide. Theoretically framed within the Addiction Neuroclinical Assessment (ANA) with hypothesized mechanisms in core domains (i.e., incentive salience, negative emotionality and cognitive function), and proceeding from a sound and innovative scientific premise, we will, for the first time, target smoking and alcohol use by implementing an evidence-based behavioral treatment (CM) for alcohol among participants who have initiated frontline pharmacotherapy (varenicline; VC) for smoking cessation. This project seeks to replicate, harness and extend our previous findings from secondary analyses and pilot studies, which demonstrate that applying CM to target the use of alcohol can produce non- targeted reductions in smoking. We will do so by offering CM for alcohol use to smokers who are simultaneously initiating smoking cessation pharmacotherapy. We also seek to identify the most potent ANA-based mediators (e.g., incentive salience given that CM’s focus is on alternative reinforcement) of behavior change in response to treatment. Lastly, we will examine the extent to which biologic sex and baseline alcohol use and cigarette smoking interacts with CM to produce different levels of reduced alcohol use and cigarette smoking. Patients will take part in a 2-arm randomized controlled trial to evaluate the ability of a CM intervention to reduce alcohol use and cigarette smoking. After completing a 2-week induction period, patients will be randomized into 2 trial arms for a 12-week treatment period: 1) a CM intervention group that receives smoking cessation treatment as usual (TAU), which includes varenicline and counseling, and 2) a non-contingent (NC) control group that also receives TAU. Our Specific Aims are to: 1) Determine if CM+TAU is more effective than NC+TAU for reducing alcohol use and cigarette smoking. We hypothesize that CM will yield lower rates of biochemically-verified alcohol use and cigarette smoking, concurrent biochemically-verified alcohol use and smoking, and self-reported drinks per day, cigarettes per day, and heavy drinking days during the 12-week treatment and 6-month follow-up periods. 3) Identify the most potent ANA-based mediators of treatment response across the treatment groups. We hypothesize that higher executive dysfunction, negative emotionality, and alcohol- and smoking-related incentive salience will be associated with higher levels of alcohol use and cigarette smoking across treatments and over time; 3) Determine if biological sex or baseline severity of alcohol use and smoking interacts with treatment assignment to produce differential changes in our primary and secondary outcomes. We hypothesize that biological sex will significantly interact with treatment to produce differential outcomes, and that those with less severity of alcohol use and smoking at baseline will experience better outcomes. This investigation will support future studies that can identify personalized treatment for different sub-groups of smokers with an AUD.


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 = $539,828 )
2025	2025	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Cancer Cause and Prevention Research	000	5	6/13/2025	NON-COMPETING CONTINUATION	$539,828
														Subtotal = $539,828

Issue Date FY: 2024 ( Subtotal = $529,622 )
2024	2024	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Cancer Cause and Prevention Research	000	4	4/24/2024	NON-COMPETING CONTINUATION	$529,622
														Subtotal = $529,622

Issue Date FY: 2023 ( Subtotal = $562,526 )
2023	2023	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Cancer Cause and Prevention Research	000	3	5/1/2023	NON-COMPETING CONTINUATION	$562,526
														Subtotal = $562,526

Issue Date FY: 2022 ( Subtotal = $578,081 )
2022	2022	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Cancer Cause and Prevention Research	000	2	7/13/2022	NON-COMPETING CONTINUATION	$578,081
														Subtotal = $578,081

Issue Date FY: 2021 ( Subtotal = $600,704 )
2021	2021	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Cancer Cause and Prevention Research	000	1	4/28/2021	NEW	$600,704
														Subtotal = $600,704

Grand Total All Awards = $2,810,761

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An Addictions Neuroclinical Assessment Based Treatment for Smokers with an Alcohol Use Disorder

Award Number: R01CA252185

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/01/2021

PERIOD OF PERFORMANCE END DATE: 04/30/2026

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