Ketamine for OUD and Suicidal Ideation in the ED

NCT06111339 | Terminated Phase 2 FDA Drug

• 1 other identifier: 2023P002857
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Opioid Use Disorder; Suicidal Ideation

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (9)

• Opioid Withdrawal

  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

  7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.

• Percentage of Addiction Treatment Engagement

  28 days after being discharged from inpatient unit or emergency department.

• Urine Toxicology Result for Ketamine

  28 days after being discharged from inpatient unit or emergency department.

• Urine Toxicology Result for Opioids

  28 days after being discharged from inpatient unit or emergency department.

Study Arms (2)

Ketamine

EXPERIMENTAL

This arm will receive ketamine (n=25)

Drug: Ketamine

Saline Placebo

PLACEBO COMPARATOR

This arm will receive the saline placebo (n=25)

Other: Saline Solution

Interventions

Ketamine DRUG

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

Ketamine

Saline Solution OTHER

The placebo will be a 0.9% saline solution administered over 40 minutes.

Saline Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Suicidal Ideation

Interventions

Ketamine; Saline Solution

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will then be randomized in a double-blind fashion to receive either ketamine (0.8 mg/kg) or a matched volume saline placebo in the ED. Randomization will use a permuted block method58. The randomization ratio will be 1:1. A biostatistician will generate the randomization codes and provide the randomization list to the hospital's Investigational Drug Services (IDS). The study RA will contact IDS once the participant has signed informed consent and IDS staff will randomize participants. Both RA, study team and the clinical team will be blinded to the allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Addiction Psychiatry

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: November 1, 2023
• Study Start: June 14, 2024
• Primary Completion: March 11, 2025
• Study Completion: March 31, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

US (1)