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Zonisamide for the Treatment of Alcohol Use Disorder in the Addiction Neuroclinical Assessment Framework

Award Number: R01AA028796
ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2020
PERIOD OF PERFORMANCE END DATE: 07/31/2025

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Zonisamide for the Treatment of Alcohol Use Disorder in the Addiction Neuroclinical Assessment Framework - PROJECT SUMMARY/ABSTRACT Alcohol use disorder (AUD) is an alarming public health problem that costs the US more than $249 billion annually. AUDs leads to a devastatingly diverse set of negative health outcomes, including significantly increased risk of hypertension, stroke, pancreatitis, liver cirrhosis, Alzheimer’s disease, multiple cancers, and multiple types of cognitive dysfunction. Disulfiram, naltrexone, and acamprosate are the only FDA-approved medications for the treatment of AUD and are only modestly effective. Zonisamide (ZON) is an anticonvulsant medication with GABAnergic, glutamatergic and monoaminergic effects which has shown significant promise in animal and human laboratory settings, and small clinical trials for the treatment of AUD. ZON could represent a critical new tool for clinicians, but previous studies have been limited by a couple of key factors (e.g., no objective evidence recent alcohol consumption, no objective evidence of medication adherence) that this study is designed to overcome. Theoretically framed within the Addiction Neuroclinical Assessment with hypothesized mechanisms in core domains (i.e., incentive salience, negative emotionality and cognitive function), and proceeding from a sound scientific premise we will target reduced alcohol use among AUD patients in primary care using a carefully designed combination of contingency management (CM, or incentives in exchange for objectively verified evidence of behavior) delivered at thrice-weekly visits during the first 4- weeks of ZON treatment to jumpstart reductions in drinking. For the remaining 8-weeks of ZON, CM will be delivered at weekly visits in exchange for evidence of 100% or higher medication adherence. The goal of this study is to complete a double-blind, placebo-controlled RCT to evaluate the ability of ZON to significantly decrease alcohol use among treatment-seeking AUD adults. Individuals will be randomized into 1 of 2 trial arms that will receive: 1) ZON plus standard treatment (ST), which includes Take Control bibliotherapy modules and CM through the 12-week treatment period (ZON+ST), or 2) Matched placebo plus ST (PLO+ST). The primary outcome will be biochemically-verified alcohol use during the treatment period. We will use a 2-week, single- blind placebo induction period wherein participants will be required to demonstrate a 75% medication adherence rate before continuing into the 12-week treatment period. Follow-up will occur at 1, 6 and 12-months. Our Specific Aims are to: 1) Determine if ZON+ST is more effective than PLO+ST for reducing biochemically- verified alcohol use and other alcohol use outcomes; 2) Identify ANA-based mediators of treatment response across the treatment groups; 3) Determine a.) if biological sex, baseline depression and baseline severity of alcohol use interacts with treatment assignment to produce differential changes in our primary and secondary outcomes; and b.) whether groups differ on adverse events or medication adherence. This project focuses on the efficacy of a promising pharmacotherapy for AUDs using a double-blind placebo-controlled design that will rigorously measure alcohol use and medication adherence.


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 = $586,597 )
2024	2024	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Alcohol Research Programs	000	5	7/15/2024	NON-COMPETING CONTINUATION	$586,597
														Subtotal = $586,597

Issue Date FY: 2023 ( Subtotal = $635,863 )
2023	2023	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Alcohol Research Programs	000	4	8/23/2023	NON-COMPETING CONTINUATION	$635,863
														Subtotal = $635,863

Issue Date FY: 2022 ( Subtotal = $635,863 )
2022	2022	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Alcohol Research Programs	000	3	7/14/2022	NON-COMPETING CONTINUATION	$635,863
														Subtotal = $635,863

Issue Date FY: 2021 ( Subtotal = $635,863 )
2021	2021	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Alcohol Research Programs	000	2	7/26/2021	NON-COMPETING CONTINUATION	$635,863
														Subtotal = $635,863

Issue Date FY: 2020 ( Subtotal = $665,501 )
2020	2020	WASHINGTON STATE UNIVERSITY	240 FRENCH ADMINISTRATION BLDG	PULLMAN	WA	99164	WHITMAN	USA	Alcohol Research Programs	000	1	9/11/2020	NEW	$665,501
														Subtotal = $665,501

Grand Total All Awards = $3,159,687

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Zonisamide for the Treatment of Alcohol Use Disorder in the Addiction Neuroclinical Assessment Framework

Award Number: R01AA028796

ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/15/2020

PERIOD OF PERFORMANCE END DATE: 07/31/2025

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