Skip to content
TerminatedPhase 2

Ketamine for OUD and Suicidal Ideation in the ED

NCT06111339 · Brigham and Women's Hospital

Closed to entry
Status
Not accepting participants
Phase 2
Phase
4
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Lower Suicidal Ideation

    Measured over 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

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

  • Incidence of Serious Adverse Events (SAE)

    Measured over From the beginning on the infusion, every 15 minutes throughout infusion, and at the end of the infusion.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
Brigham and Women's HospitalBostonMassachusettsUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06111339 on ClinicalTrials.gov →

Last updated in the registry 2025-04-08. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits