RECRUITING

Ketamine & Crisis Response Plan for Suicidal Ideation in the ED

Conditions

Suicide Ketamine Crisis Response Plan Suicidal Ideation Emergency Department Acute Suicidality Intramuscular Ketamine Emergency Room

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this randomized pilot trial is to assess the feasibility of administering a combination of 100mg intramuscular (IM) ketamine and Crisis Response Plan (a short psychosocial intervention) for patients with acute suicidality in the context of the Emergency Department setting. This study will assess a combination of a pharmacologic intervention and a psychosocial one. The pharmacologic intervention is a one-time dose of 100mg ketamine delivered intramuscularly (IM) while the patient is in the ED. The psychosocial intervention under study is a brief, patient-centered therapy which takes, on average, 30 minutes to administer. Both interventions will be administered only once. The main questions this study aims to answer are: * Determine if 100mg of IM ketamine and Crisis Response Plan in combination results in greater short-term reductions in suicidal ideation in adult patients who report acutely elevated suicide risk during an ED visit. * Examine potential weight-based dose response differences in the reductions in suicidal ideation to determine if future treatment protocols with IM ketamine may benefit from weight-based dosing.

Official Title

A Randomized Pilot Trial of Intramuscular Ketamine and Crisis Response Planning for Suicide Prevention in the Emergency Department

Quick Facts

Study Start:2023-01-06

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05696691

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Adult men and women between the ages of 18 and 70 presenting to the Emergency Department with acute suicidal ideation. * Patient cleared for admission to the University Hospital inpatient psychiatric unit. * Decision to admit the patient to the inpatient unit or psychiatric stabilization unit made prior to consent to prevent study procedures from complicating or influencing the disposition and treatment as usual for suicidal patients reporting to the ED. * Individuals presenting to the ED for other complaints but found to have suicidal ideation necessitating admission will also be eligible. * Able to read and write English.	* Serious mental illness with active and significant signs of psychosis, mania, hallucinations, paranoia, agitation, and drug-induced or other toxidromic symptoms. * Acute intoxication with clinically significant symptoms (as defined by the attending clinician's assessment of patients' clinical sobriety). * The patient is not capable of understanding the research procedures and providing informed consent for themselves. * Lack of reliable means to be available for follow-up assessments (e.g, working mobile phone). * 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. * Pregnancy or breast feeding. * Known hypersensitivity to ketamine. * Legal or illegal use of ketamine in the previous 90 days. * End-stage or severe cardiovascular (e.g., ACS or decompensated heart failure), liver, or kidney disease. * Patient is a prisoner. * Patient is physically restrained or actively under custody of law enforcement. Once a patient is no longer under custody of law enforcement or physically restrained, the patient may be considered eligible and may consent to voluntary enrollment in the study.

Inclusion Criteria

Exclusion Criteria

* Adult men and women between the ages of 18 and 70 presenting to the Emergency Department with acute suicidal ideation.
* Patient cleared for admission to the University Hospital inpatient psychiatric unit.
* Decision to admit the patient to the inpatient unit or psychiatric stabilization unit made prior to consent to prevent study procedures from complicating or influencing the disposition and treatment as usual for suicidal patients reporting to the ED.
* Individuals presenting to the ED for other complaints but found to have suicidal ideation necessitating admission will also be eligible.
* Able to read and write English.

* Serious mental illness with active and significant signs of psychosis, mania, hallucinations, paranoia, agitation, and drug-induced or other toxidromic symptoms.
* Acute intoxication with clinically significant symptoms (as defined by the attending clinician's assessment of patients' clinical sobriety).
* The patient is not capable of understanding the research procedures and providing informed consent for themselves.
* Lack of reliable means to be available for follow-up assessments (e.g, working mobile phone).
* 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.
* Pregnancy or breast feeding.
* Known hypersensitivity to ketamine.
* Legal or illegal use of ketamine in the previous 90 days.
* End-stage or severe cardiovascular (e.g., ACS or decompensated heart failure), liver, or kidney disease.
* Patient is a prisoner.
* Patient is physically restrained or actively under custody of law enforcement. Once a patient is no longer under custody of law enforcement or physically restrained, the patient may be considered eligible and may consent to voluntary enrollment in the study.

Contacts and Locations

Study Contact

Stehanie Perez, MHA

CONTACT

2104508973

perezs11@uthscsa.edu

Principal Investigator

Robert De Lorenzo, MD, MSM

PRINCIPAL_INVESTIGATOR

UT Health San Antonio

Romeo Fairley, MD, MPH

STUDY_DIRECTOR

UT Health San Antonio

Alan Peterson, PhD, ABPP

STUDY_DIRECTOR

UT Health San Antonio

Stacey Young-McCaughan, RN, PhD

STUDY_DIRECTOR

UT Health San Antonio

Study Locations (Sites)

University Hospital

San Antonio, Texas, 78229

United States

Collaborators and Investigators

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

Robert De Lorenzo, MD, MSM, PRINCIPAL_INVESTIGATOR, UT Health San Antonio
Romeo Fairley, MD, MPH, STUDY_DIRECTOR, UT Health San Antonio
Alan Peterson, PhD, ABPP, STUDY_DIRECTOR, UT Health San Antonio
Stacey Young-McCaughan, RN, PhD, STUDY_DIRECTOR, UT Health San Antonio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-06

Study Completion Date2026-12

Study Record Updates

Study Start Date2023-01-06

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Ketamine
Crisis Response Plan
Suicidal Ideation
Emergency Department
Acute Suicidality
Intramuscular Ketamine
Emergency Room

Additional Relevant MeSH Terms

Suicide