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

The National Institute on Alcohol Abuse and Alcoholism awarded Denver Health and Hospital Authority $189,000 on September 1, 2026, under the Alcohol Research Programs (CFDA 93.273) to support a project grant for ketamine therapy research in alcohol use disorder.

Principal investigator Dale Terasaki, MD, MPH, an addiction medicine specialist at Denver Health, will conduct a hospital-based clinical trial and real-world outcomes study of ketamine as a pharmacotherapy for alcohol use disorder (AUD) in hospitalized patients. The research addresses gaps in current treatment options for high-risk, frequently hospitalized patients with AUD. Dr. Terasaki's prior pilot work demonstrated promising reductions in hospital readmissions but identified challenges in obtaining accurate alcohol use outcomes, suggesting a need for biomarker validation and alternative measurement approaches. The study will also examine risks associated with non-prescribed ketamine use and ketamine use disorder development in community settings.

The award supports both research activities and career development. Dr. Terasaki will pursue training and individualized instruction in pharmacoepidemiologic assessment of novel treatments, clinical trial design and management in medical settings, and alcohol outcome validation by biomarker and other measures. These training goals are aligned with the research aims and intended to support pursuit of future R01 funding.

Work is performed in Denver, Colorado, with a period of performance from September 1, 2026, through August 31, 2031. The assistance type is a Project Grant.

Abstract

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.