Ketamine for OUD and Suicidal Ideation in the ED

Suicidal Ideation Clinical Trial

Official title:

Ketamine for the Treatment for Opioid Use Disorder and Suicidal Ideation in the Emergency Department

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111339
• Other study ID #: 2023P002857
• Status: Recruiting
• Phase: Phase 2
• Start date: May 13, 2024
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: Brigham and Women's Hospital
• Contact: Joji Suzuki, MD
• Phone: 617-732-5752
• Email: jsuzuki2[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English speaking adults aged 18 and above
• Diagnosed with DSM5 opioid use disorder, moderate or severe
• Endorsing suicidal ideation sufficiently severe to meet criteria for referral to an inpatient psychiatric facility or a crisis stabilization unit
• Any prior history of an opioid overdose
• Medically cleared

Exclusion Criteria:

• Any psychotic disorder, bipolar disorder, active homicidally
• Inability to perform consent due to impaired mental status, including substance intoxication
• Systolic blood pressure persistently elevated above 160mmHg, diastolic blood pressure greater than 100mmHg,or heart rate >100bmp, in the ED
• Clinical Opioid Withdrawal Scale (COWS) score of 12 or greater
• History of hypersensitivity to ketamine, or experience of emergence reaction
• History of hypersensitivity to ondansetron or concurrently using apomorphine
• History of any illicit or recreational use of ketamine in the past 12 months
• Receipt of ketamine treatment for depression in the past 3 months
• History of DSM5 hallucinogen use disorder, intracranial mass or bleed, porphyria, thyrotoxicosis, seizure disorder other than from alcohol withdrawal, liver cirrhosis, obstructive lung disease, or sleep apnea
• Cardiac or EKG abnormalities based on history, physical examination or the baseline EKG
• History within 6 months of thoracic surgery, lung cancer, head trauma, stroke, or myocardial infarction
• Liver dysfunction with LFTs >3x upper normal limit
• Current use of medications with known drug-drug interactions with ketamine (i.e., St. John's Wort, theophylline, opioid analgesics other than buprenorphine and methadone for the treatment OUD, CNS depressants other than benzodiazepines or phenobarbital)
• Pregnant
• Patients who are breastfeeding
• ASA class 3 or greater or documented history of difficult airway in EHR

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Suicidal Ideation

Intervention

Drug:
• Ketamine
The intervention will consist of a single infusion of ketamine in the ED at a dose of 0.8mg/kg over 40 minutes.

Other:
• Saline Solution
The placebo will be a 0.9% saline solution administered over 40 minutes.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 days after being discharged from inpatient unit or emergency department.
Primary	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.	7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.
Primary	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.	From the beginning on the infusion, every 15 minutes throughout infusion, and at the end of the infusion.
Secondary	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	Assessed daily while the participant remains in the ED, starting with the day that the ketamine/placebo infusion occurs until the discharge date.
Secondary	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.	7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.
Secondary	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.	28 days after being discharged from inpatient unit or emergency department.
Secondary	Urine Toxicology Result for Ketamine	The urine drug screen result (positive or negative) for ketamine will be assessed.	28 days after being discharged from inpatient unit or emergency department.
Secondary	Urine Toxicology Result for Opioids	The urine drug screen result (positive or negative) for opioids will be assessed.	28 days after being discharged from inpatient unit or emergency department.
Secondary	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.	28 days after being discharged from inpatient unit or emergency department.
Secondary	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	28 days after being discharged from inpatient unit or emergency department.
Secondary	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.	7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.
Secondary	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.	7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.