Status:
TERMINATED
Ketamine for OUD and Suicidal Ideation in the ED
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Opioid Use Disorder
Suicidal Ideation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 si...
Detailed 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 treatme...
Eligibility Criteria
Inclusion
- Inclusion/Exclusion Criteria:
- To be eligible, individuals must be/have:
- English speaking adults aged 18 and above
- Diagnosed with DSM5 opioid use disorder, moderate or severe, or clinically suspected opioid use disorder
- 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
- Individuals with any of the following will be excluded:
- Any psychotic disorder or active homicidally
- Inability to perform consent due to impaired mental status
- Current substance intoxication or current (or within the past 1-month) mania, hypomania, mixed-episode, or psychosis
- Systolic blood pressure persistently elevated above 160mmHg, diastolic blood pressure greater than 100 mmHg, 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, 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, Central Nervous System (CNS) depressants other than benzodiazepines or phenobarbital)
- Pregnant
- Patients who are breastfeeding
- ASA class 3 or greater or documented history of difficult airway in HER
- Active exacerbation of COPD or asthma
- Currently participating or anticipated to participate in a concurrent investigational clinical trial
- High risk for adverse emotional or behavioral reaction based on the opinion of the study investigators, including evidence of a personality disorder
Exclusion
Key Trial Info
Start Date :
June 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT06111339
Start Date
June 14 2024
End Date
March 31 2025
Last Update
April 8 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115