This is a pilot, double-blind, placebo-controlled randomized clinical trial of individuals with opioid use disorder (OUD) with suicidal ideation in the emergency department (ED) to receive either a single infusion of ketamine 0.8mg/kg (n=25) or saline placebo (n=25). The primary aim is to evaluate the safety of the ketamine treatment. The secondary aim is to determine the preliminary efficacy of opioid- and suicide-related outcomes.
Individuals with opioid use disorder (OUD) seeking medical care in the emergency department (ED) will be first evaluated as per usual clinical care by the ED staff, including any acute medical treatment for overdose or any other acute medical issues needing treatment. For those who endorse suicidal ideation, after medical clearance, the standard medical care will involve the evaluation of patients by the psychiatry consult service in the ED. Patients evaluated by psychiatry who require further behavioral health care and do not have acute medical issues remain in the ED awaiting admission to an inpatient psychiatry unit or other linkages to care. Potential participants will be approached after the psychiatry evaluation is complete and a decision has been made to keep the patients in the ED for continued psychiatric care or admit them medically. After applying the full inclusion and exclusion criteria, those who remain eligible will be randomized to receive in a double-blind fashion either a single infusion of ketamine (0.8mg/kg) or a saline placebo. Safety assessments will be conducted during and after the receipt of ketamine or placebo, and at follow-up assessments after discharge from the emergency department of the hospital following inpatient psychiatric treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
4
The intervention will consist of a single infusion of ketamine in the ED at a dose of 0.8mg/kg over 40 minutes.
The placebo will be a 0.9% saline solution administered over 40 minutes.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Lower Suicidal Ideation
For suicidal ideation, the Columbia Suicide Severity Rating Scale (C-SSRS), which is a 5-item tool, will be used to assess suicidal ideation.
Time frame: 7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.
Less Illicit Opioid Use
For illicit opioid use, the outcome is the proportion of abstinent days during the 28-day period after discharge from the ED or the inpatient psychiatric unit, assessed using the self-report Timeline Follow Back (TLFB). The TLFB is a gold-standard calendar method to assess substance use in the prior 28 days.
Time frame: 28 days after being discharged from inpatient unit or emergency department.
Incidence of Serious Adverse Events (SAE)
The primary safety outcome is the incidence of serious adverse events (SAE) defined as hypertensive urgency (SBP\>180mmHg or DBP\>110mmHg) or tachycardia (HR\>130bmp). Vital signs will be monitored throughout the ketamine administration.
Time frame: From the beginning on the infusion, every 15 minutes throughout infusion, and at the end of the infusion.
Opioid Withdrawal
Opioid withdrawal will be measured using the Clinical Opioid Withdrawal Scale (COWS). Scoring: 5-12 = mild 13-24 = moderate 25-36 = moderately severe \>36 = severe withdrawal
Time frame: Assessed daily while the participant remains in the ED, starting with the day that the ketamine/placebo infusion occurs until the discharge date.
Days to Relapse
Days to Relapse will be assessed using the self-report Timeline Follow Back (TLFB). The TLFB is a gold-standard calendar method to assess substance use in the prior 28 days.
Time frame: 7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.
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Percentage of Addiction Treatment Engagement
Evaluating whether the patient is engaged or not in treatment, such as meeting their primary care physician or addiction specialist.
Time frame: 28 days after being discharged from inpatient unit or emergency department.
Urine Toxicology Result for Ketamine
The urine drug screen result (positive or negative) for ketamine will be assessed.
Time frame: 28 days after being discharged from inpatient unit or emergency department.
Urine Toxicology Result for Opioids
The urine drug screen result (positive or negative) for opioids will be assessed.
Time frame: 28 days after being discharged from inpatient unit or emergency department.
Emergence of Psychiatric Adverse Effects
The CADSS is a scale with 6 subject-rated items. Items are divided into 3 components-depersonalization, derealization, and amnesia.
Time frame: 28 days after being discharged from inpatient unit or emergency department.
Emergence of Psychiatric Adverse Effects
The PRISE is a patient self-report tool used to qualify side effects in the following domains: gastrointestinal, heart, skin, nervous system, eyes/ears, genital/urinary, sleep, sexual functioning, and other. Each domain has multiple symptoms which can be endorsed. For each domain the patient rates whether the symptoms are tolerable or distressing
Time frame: 28 days after being discharged from inpatient unit or emergency department.
Craving for Opioids
The Opioid Craving Questionnaire (3-item scale) will assess opioid craving. Each question assesses opioid craving with answer choices ranging from 0 (not at all) to 10 (extremely strong) or 0 (not at all) to 10 (I'm sure I would use opiates). A higher score for each question indicates higher opioid cravings.
Time frame: 7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.
Craving for Ketamine
The Ketamine Craving Questionnaire (3-item scale) will assess ketamine craving. Each question assesses ketamine craving with answer choices ranging from 0 (not at all) to 10 (extremely strong) or 0 (not at all) to 10 (I'm sure I would use ketamine). A higher score for each question indicates higher ketamine cravings.
Time frame: 7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.