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Integrated Therapies for Alcohol use in Alcohol-associated Liver Disease (ITAALD) – Mayo Clinic

Award Number: U01AA026974
ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2018
PERIOD OF PERFORMANCE END DATE: 06/30/2029

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Integrated Therapies for Alcohol use in Alcohol-associated Liver Disease (ITAALD) – Mayo Clinic - Alcohol-associated liver disease (ALD) is a leading cause of liver-related mortality/morbidity, and there is no FDA-approved therapy for any stage of ALD. Advanced ALD conditions, including severe alcohol-associated hepatitis (sAH) have especially poor outcomes. Indeed, the 90-day mortality for sAH is ~30%. Return to drinking impacts quality of life, morbidity and mortality in these patients. There are limited drug therapies or well-studied behavior therapies in this patient population. An optimal approach would be the integration of AUD and ASLD care givers and therapies, but there are no guidelines for this approach. Our proposed AUD/ALD team approach seeks to overcome the perceived stigma of alcohol misuse which can adversely affect treatment seeking, quality of care and patient outcomes. The AlcHepNet RCT was stopped at the interim analysis because of the unexpected 90% 90-day survival in sAH patients treated with prednisone using the Lille stopping rule. These dramatic results need to be confirmed, and novel therapies such as IL-22 need to be studied in sAH. Acamprosate appears to be the safest FDA-approved therapy for AUD in patients with ALD, but safety and efficacy in severe ALD need to be evaluated. Motivational interviewing/enhancement therapy is well-suited behavioral therapy for patients with ALD. Based on preliminary data and knowledge gaps, our overall hypothesis is that integrated management of ALD and AUD will improve clinical outcomes in patients with sAH and decompensated ALD. We will utilize the following AIMS: Aim 1. Perform a randomized controlled trial of treatment for steroid-eligible patients with severe AH. A SMART trial design will be used to compare daily prednisone for 28 days (with the 7-day Lille score-based stopping rule) vs IL-22 fusion protein (F-652) followed by randomization of each of these groups to receive motivational Interviewing/enhancement therapy combined with acamprosate vs usual care including referral to 12-step programs before discharge from the hospital. The primary endpoint of the trial will be a composite measure of mortality, liver, and alcohol use related outcomes at 6 months. AIM 2. Build a platform for biosamples, data repositories, and patient registries to support site-specific and network-wide ancillary studies. In summary, these proposed studies will leverage the existing resources of the AlcHepNet to evaluate the clinical impact of integrated ALD/AUD treatment in a cohort of patients for whom there are limited treatment options.


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 = $355,080 )
2025	2025	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Alcohol Research Programs	003	7	8/27/2025	NON-COMPETING CONTINUATION	$355,080
2025	2024	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Alcohol Research Programs	001	6	2/12/2025	COMPETING CONTINUATION	$1
2025	2024	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Alcohol Research Programs	002	6	8/26/2025	COMPETING CONTINUATION	$0
2025	2022	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Alcohol Research Programs	000	5	2/12/2025	NON-COMPETING CONTINUATION	-$1
														Subtotal = $355,080

Issue Date FY: 2024 ( Subtotal = $355,080 )
2024	2024	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Alcohol Research Programs	002	6	9/18/2024	COMPETING CONTINUATION	$355,080
2024	2022	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Alcohol Research Programs	001	5	9/18/2024	NON-COMPETING CONTINUATION	$0
2024	2022	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Alcohol Research Programs	000	5	5/30/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $355,080

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Alcohol Research Programs	000	5	9/28/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $369,000 )
2022	2022	MAYO CLINIC	200 FIRST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Alcohol Research Programs	001	5	6/15/2022	NON-COMPETING CONTINUATION	$369,000
2022	2021	MAYO CLINIC	200 FIRST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Alcohol Research Programs	000	4	5/18/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $369,000

Issue Date FY: 2021 ( Subtotal = $380,152 )
2021	2021	MAYO CLINIC	200 FIRST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Alcohol Research Programs	001	4	7/2/2021	NON-COMPETING CONTINUATION	$380,152
2021	2020	MAYO CLINIC	200 FIRST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Alcohol Research Programs	000	3	12/17/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $380,152

Issue Date FY: 2020 ( Subtotal = $380,152 )
2020	2020	MAYO CLINIC	200 FIRST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Alcohol Research Programs	002	3	6/24/2020	NON-COMPETING CONTINUATION	$380,152
2020	2019	MAYO CLINIC	200 FIRST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Alcohol Research Programs	000	2	11/28/2019	NON-COMPETING CONTINUATION	$0
2020	2019	MAYO CLINIC	200 FIRST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Alcohol Research Programs	001	2	5/5/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $380,152

Issue Date FY: 2019 ( Subtotal = $380,152 )
2019	2019	MAYO CLINIC	200 FIRST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Alcohol Research Programs	002	2	7/25/2019	NON-COMPETING CONTINUATION	$380,152
2019	2018	MAYO CLINIC	200 FIRST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Alcohol Research Programs	001	1	4/17/2019	SUPPLEMENT FOR EXPANSION	$0
2019	2018	MAYO CLINIC	200 FIRST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Alcohol Research Programs	000	1	4/16/2019	NEW	$0
														Subtotal = $380,152

Issue Date FY: 2018 ( Subtotal = $373,780 )
2018	2018	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Alcohol Research Programs	000	1	7/30/2018	NEW	$369,000
2018	2018	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Alcohol Research Programs	001	1	9/25/2018	SUPPLEMENT FOR EXPANSION	$4,780
														Subtotal = $373,780

Grand Total All Awards = $2,593,396

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Integrated Therapies for Alcohol use in Alcohol-associated Liver Disease (ITAALD) – Mayo Clinic

Award Number: U01AA026974

ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 08/01/2018

PERIOD OF PERFORMANCE END DATE: 06/30/2029

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