Ketamine for OUD and Suicidal Ideation in the ED

• Status: Recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Ketamine

Criteria

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