NCT06111339

Ketamine for OUD and Suicidal Ideation in the ED

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Opioid Use Disorder
• Suicidal Ideation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-14
• Primary completion: 2025-03-11
• Completion: 2025-03-31
• First posted: 2023-11-01
• Last updated: 2025-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study