NCT07868913 · The University of Texas Health Science Center at San Antonio
Alleviating Suicidality by Combining Psychotherapy and IM Ketamine for Rapid Treatment in the Emergency Department
(ASPIRED)
What this study is about
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.
View original scientific description
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.
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
Primary outcome measures
Depressive Symptoms Index - Suicidality Subscale (DSI-SS)
Time frame: Baseline, 24 hours and 28 days
A 4 item scale scored from 0-3 for each item and summed to give a total between 0-12 with a higher score indication greater suicidal ideation.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 UH or 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.
Where
- Fort Hood, Texas
- San Antonio, Texas
Collaborators
United States Department of Defense
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 9, 2026 · Source of record for eligibility and locations