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Ketamine therapy for alcohol use disorder: real-world insights and hospital-based clinical trial

Award Number: K23AA033457
ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 09/01/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2031

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Ketamine therapy for alcohol use disorder: real-world insights and hospital-based clinical trial - PROJECT SUMMARY 1 CANDIDATE: Dale Terasaki, MD, MPH, is a hospital-based addiction medicine specialist who is committed to 2 reducing the morbidity and mortality of patients with alcohol and substance use disorders (AUD/SUD). His 3 career goal is to become a leading expert in ketamine/psychedelics and independent clinical researcher 4 developing innovative pharmacotherapies for AUD/SUD in medical settings. 5 CAREER DEVELOPMENT: To achieve this career goal, Dr. Terasaki will pursue coursework, trainings, 6 and individualized instruction in three specific areas: (1) pharmacoepidemiologic assessment of risks & 7 benefits of novel treatments to inform research & practice, (2) clinical trial design & management in medical 8 settings, and (3) alcohol outcome validation by biomarker and other measures. These training goals are closely 9 aligned with the research aims in this proposal and will catalyze the pursuit of future R01 funding. 10 RESEARCH CONTEXT: AUD ranks among the most prominent causes of medical illness and suffering in the 11 United States, with alcohol contributing to at least 1 of every 5 hospital admissions. Current options are largely 12 insufficient for the highest-risk patients who are frequently admitted to the hospital. The NMDA antagonist, 13 ketamine, may be well suited for these patients, and Dr. Terasaki conducted a pilot trial among hospitalized 14 patients with AUD finding promising results in terms of readmissions. Yet accurate alcohol use outcomes were 15 difficult to obtain, suggesting a corroborating role for biomarkers and other measures among this population. 16 Amid development of ketamine as a therapeutic agent for AUD/SUD, its non-prescribed use and development 17 of SUD is also proliferating in community settings, warranting further inquiry into this risk. 18 SPECIFIC AIMS: The goal of this proposal is to generate inferences about risks and benefits ketamine as a 19 hospital-based treatment for AUD. Aim 1: Determine if the presence of AUD diagnosis is associated with 20 higher odds of risky ketamine use using a case control design in a nationally representative surveillance tool. 21 Aim 2: Conduct a phase II randomized trial (n=70) of high-dose vs low-dose ketamine among hospitalized 22 patients with high-utilization AUD. Aim 3: Corroborate the self-reported primary trial outcome (2-level reduction 23 in WHO risk drinking level) by the alcohol biomarker, phosphatidylethanol (PEth). 24 MENTORSHIP: Dr. Terasaki has assembled a team of mentors, advisors, and consultants with extensive 25 experience supervising research and with complementary expertise in drug surveillance, alcohol clinical trials, 26 and ketamine pharmacotherapy. 27 ENVIRONMENT: Denver Health & Hospital Authority (safety net hospital system) and The University of 28 Colorado Anschutz Medical Campus (affiliated academic center) offer an ideal multi-institution environment to 29 pursue this training and research. Dr. Terasaki will succeed because of a dedicated mentorship/advisory team, 30 targeted clinical setting, and outstanding research infrastructure.


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: 2026 ( Subtotal = $189,000 )
2026	2026	DENVER HEALTH AND HOSPITAL AUTHORITY	777 BANNOCK ST	DENVER	CO	80204	DENVER	USA	Alcohol Research Programs	000	1	9/3/2026	NEW	$189,000
														Subtotal = $189,000

Grand Total All Awards = $189,000

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Ketamine therapy for alcohol use disorder: real-world insights and hospital-based clinical trial

Award Number: K23AA033457

ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 09/01/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2031

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