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RECRUITING

NCT07868913

PHASE2

Alleviating Suicidality by Combining Psychotherapy and IM Ketamine for Rapid Treatment in the Emergency Department

Sponsor: The University of Texas Health Science Center at San Antonio

View on ClinicalTrials.gov

Summary

Participants are asked to take part in this research study after coming to the Emergency Department with thoughts or behaviors of seriously hurting themselves. There are very few resources to treat acute suicidal thoughts or behaviors in an emergency department. The purpose of this study is to evaluate the effectiveness of combining an intramuscular (IM) injection of ketamine and Crisis Response Planning (CRP), a single, 45-60 minute psychological intervention with a therapist, to quickly reduce suicidal thoughts in patients treated in an emergency department (ED) prior to being admitted to the hospital.

Official title: ASPIRED: Alleviating Suicidality by Combining Psychotherapy and IM Ketamine for Rapid Treatment in the Emergency Department - A Randomized Clinical Trial.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-09-30

Completion Date

2028-09-30

Last Updated

2026-10-15

Healthy Volunteers

Conditions

Suicidal Ideation

Interventions

DRUG

Ketamine Injectable Solution

1 mg.kg IM ketamine is administered after enrollment and randomization

OTHER

Placebo Injection

Placebo is administered after enrollment and randomization

BEHAVIORAL

Crisis Response Plan

Crisis Response Planning is a collaborative, patient-centered psychosocial intervention that begins with a narrative assessment and concludes with the development of a personalized plan that outlines a series of self-regulatory strategies for managing acute emotional distress

OTHER

Safety Planning

The Safety Planning intervention (provided as standard of care at discharge) includes a brief review of current suicide risk, provides patients with a suite of cognitive tools for avoiding future acute crises, and allows for a discussion and teach-back period to ensure patients' understanding of and willingness to use the plan

Inclusion Criteria: * Adult men and women between the ages of 18 and 70 presenting to the Emergency Department with acute suicidal ideation anticipated to be admitted as an inpatient at University Health (UH) or Carl R Darnall Army Medical Center (CRDAMC) based on the ED and admitting providers determination that the patient warrants hospitalization for suicidality and the capacity of the institution to admit the patient. * Able to read and write English. Exclusion Criteria: * Serious mental illness with active and significant signs of psychosis, mania, hallucinations, paranoia, agitation, and drug-induced or other toxidromic symptoms determined to be the priority of treatment relative to treatment of the suicidal thoughts and behaviors. * Acute intoxication with clinically significant symptoms as determined by the ED provider to significantly increase the risk of participation (e.g., potential interaction with ketamine) or render the patient unable to consent. * The patient is not capable of understanding the research procedures and providing informed consent for themselves as determined by the research staff obtaining informed consent in consultation with the patient's ED provider. * Admittance to and treatment in an ED for acute suicidality within the past 30 days as determined by self-report, or if available, hospital records. * Lack of reliable means to be available for follow-up assessments (e. g, working mobile phone) as determined by self-report. * Persistent resting blood pressure lower than 90/60 or higher than 180/110, or persistent resting heart rate lower than 45 beats/minute or higher than 120 beats/minute. * Injuries requiring procedural sedation with ketamine as determined by the patient's ED provider. * Pregnancy as determined by pregnancy testing, or self-report of breast feeding. * Known hypersensitivity to ketamine as determined by self-report. * Legal or illegal use of ketamine in the previous 90 days as determined by self-report. * End-stage or severe cardiovascular (e.g., acute coronary syndrome (ACS) or decompensated heart failure), end-stage or severe liver, or kidney disease as determined by the ED chart history and ED provider's exam. * Patient is a prisoner as determined by prisoner escort. * Patient is physically restrained or actively under custody of law enforcement.

Locations (2)

Carl R Darnall Army Medical Center (CRDAMC)

Fort Hood, Texas, United States

University Hospital (UH)

San Antonio, Texas, United States