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The Combination of Donepezil and Cognitive Training for Treating Alcohol Use Disorder

Award Number: R01AA029075
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: 09/20/2021
PERIOD OF PERFORMANCE END DATE: 05/31/2026

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The Combination of Donepezil and Cognitive Training for Treating Alcohol Use Disorder - Project Summary/Abstract Alcohol use disorder (AUD) is a serious public health problem. Alcohol-related brain defects and alcohol- associated cognitive impairments contribute to the progression of AUD. About 50-80% of patients with AUD have cognitive impairments. These cognitive impairments persist over years and get worse with age. Moreover, alcohol-related cognitive impairments may impact AUD outcomes because executive functions and memory are necessary for self-regulation and learning, which are important during recovery. These cognitive impairments are especially prevalent in the early phase of recovery and reduce the ability to benefit from current AUD treatments. Previous research has suggested that cognitive remediation therapy (CRT) may improve cognitive function and AUD treatment outcomes. There are randomized clinical trials demonstrating that CRT reduces alcohol craving or drinking. However, a few studies also reported that CRT is not effective in reducing drinking. Thus, CRT may need to be augmented by another intervention (e.g., cognitive-enhancing pharmacotherapy) to increase the benefits of CRT. Emerging neurobiological evidence suggests that an anticholinesterase agent donepezil may treat AUD. Donepezil is currently approved by the Food and Drug Administration (FDA) for the treatment of dementia of the Alzheimer's type. Since donepezil has been clinically used as a cognitive enhancer, donepezil may treat AUD while enhancing neurocognitive functioning in patients with AUD. Our pilot data showed that donepezil + CRT might be safe and effective in treating AUD in patients with AUD and mild cognitive impairment. Thus, we here propose a 13-week, randomized, double-blind, placebo-controlled, between-subjects trial comparing 4 groups (donepezil + CRT vs. donepezil alone vs. CRT alone vs. placebos) as a treatment for AUD in a total of 160 patients with AUD. There are two main objectives. Aim #1: To evaluate if donepezil + CRT is superior to placebo in reducing heavy drinking as measured by weekly Time Line Follow Back (TLFB). We hypothesize that donepezil + CRT (group 1) is superior to placebo (group 4) in reducing heavy drinking over 13 weeks of active intervention. We also hypothesize that donepezil alone (group 2) or CRT alone (group 3) is superior to placebo (group 4) in reducing weekly heavy drinking days, and group 1 is superior to groups 2 and 3. Aim #2: To evaluate if donepezil + CRT is superior to placebo in improving global neurocognitive functioning. We hypothesize that donepezil + CRT is superior to placebo in improving global neurocognitive functioning on a global index of neurocognitive function at 7 weeks and at 13 weeks. This project will be the first randomized controlled trial testing donepezil for 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 = $475,048 )
2025	2025	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Alcohol Research Programs	000	5	5/15/2025	NON-COMPETING CONTINUATION	$475,048
														Subtotal = $475,048

Issue Date FY: 2024 ( Subtotal = $475,726 )
2024	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Alcohol Research Programs	000	4	6/28/2024	NON-COMPETING CONTINUATION	$475,726
														Subtotal = $475,726

Issue Date FY: 2023 ( Subtotal = $475,726 )
2023	2023	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Alcohol Research Programs	000	3	6/5/2023	NON-COMPETING CONTINUATION	$475,726
														Subtotal = $475,726

Issue Date FY: 2022 ( Subtotal = $475,726 )
2022	2022	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Alcohol Research Programs	001	2	5/26/2022	NON-COMPETING CONTINUATION	$475,726
2022	2021	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Alcohol Research Programs	000	1	3/2/2022	NEW	$0
														Subtotal = $475,726

Issue Date FY: 2021 ( Subtotal = $475,726 )
2021	2021	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Alcohol Research Programs	000	1	9/20/2021	NEW	$475,726
														Subtotal = $475,726

Grand Total All Awards = $2,377,952

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The Combination of Donepezil and Cognitive Training for Treating Alcohol Use Disorder

Award Number: R01AA029075

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: 09/20/2021

PERIOD OF PERFORMANCE END DATE: 05/31/2026

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