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The role of brief potent glutamatergic modulation in addressing problem drinking: a randomized, controlled trial

Award Number: R01AA027509
ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Project Summary: Alterations in glutamate neurotransmission are recognized as an important target of pharmacotherapy for alcohol use disorder (AUD). Preliminary investigations with ketamine, a glutamate modulator with potent prefrontal effects, suggest sub-anesthetic infusions may work to facilitate behavioral modification by addressing critical vulnerabilities for a variety of substance use disorders, including AUD. Expanding on a preliminary study suggesting that ketamine reduces number of heavy drinking days (HDD) when combined with motivational enhancement therapy (MET), this 12-week trial powered to detect proportional differences consistent with our prior data (n=120) aims to evaluate whether ketamine promotes a reduction in HDDs relative to an active control (midazolam). We will randomize (1:1) 120 participants seeking treatment for AUD and demonstrating high baseline problem drinking to 2 infusions of ketamine or midazolam separated by 5 weeks (0.71 mg/kg ketamine or 0.025 m/kg midazolam over 52 min). Further, in order to more rigorously assess the impact of behavioral treatment on the efficacy of ketamine, we will employ a two by two factorial (2x2) design, with participants in each medication arm randomized (1:1) either to standard medication management, or to a manualized sequence of motivational enhancement therapy (MET) followed by mindfulness-based relapse prevention (MBRP). MBRP is expected to facilitate relapse prevention after individuals have reduced use or initiated abstinence during MET. We predict that, compared to the control midazolam, ketamine will significantly reduce the proportion of individuals with HDDs. An important secondary hypothesis is that those receiving ketamine and behavioral treatment will demonstrate significantly better outcomes than individuals receiving ketamine alone. Other aims pertain to the effects of ketamine on number of daily drinks, and number of drinking days; the impact of ketamine on time to first HDD or drop-out; and the evaluation of added effectiveness when ketamine is combined with MET/MBRP. If successful, this project stands to contribute significantly to the treatment of AUD, for which new pharmacotherapy strategies are needed. Future studies might test other medications using the design introduced here, as well as focus on clarifying the mechanisms by which ketamine addresses 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: 2023 ( Subtotal = $0 )
2023	2022	RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC.	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Alcohol Research Programs	000	4	9/14/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $708,284 )
2022	2022	RESEARCH FOUNDATION FOR MENTAL HYGIENE INC	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Alcohol Research Programs	000	4	8/19/2022	NON-COMPETING CONTINUATION	$708,284
														Subtotal = $708,284

Issue Date FY: 2021 ( Subtotal = $708,284 )
2021	2021	RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC.	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Alcohol Research Programs	000	3	8/23/2021	NON-COMPETING CONTINUATION	$708,284
														Subtotal = $708,284

Issue Date FY: 2020 ( Subtotal = $708,284 )
2020	2020	RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC.	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Alcohol Research Programs	001	2	8/18/2020	NON-COMPETING CONTINUATION	$708,284
2020	2019	RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC.	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Alcohol Research Programs	000	1	1/24/2020	NEW	$0
														Subtotal = $708,284

Issue Date FY: 2019 ( Subtotal = $743,120 )
2019	2019	RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC.	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Alcohol Research Programs	000	1	9/18/2019	NEW	$743,120
														Subtotal = $743,120

Grand Total All Awards = $2,867,972

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The role of brief potent glutamatergic modulation in addressing problem drinking: a randomized, controlled trial

Award Number: R01AA027509

ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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